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The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacitidine + Durvalumab | Experimental | Participants received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
|
| Azacitidine Alone | Active Comparator | Participants received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine | Drug | Administered by subcutaneous injection on Days 1 to 7 of each 4-week treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MDS Cohort: Overall Response Rate | Overall response rate (ORR) is defined as the percentage of participants achieving a complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI) based on International Working Group (IWG) 2006 response criteria for MDS and central review. CR: ≤ 5% myeloblasts in bone marrow (BM), and peripheral blood: hemoglobin ≥ 11 g/dL; platelets ≥ 100 × 10⁹/L; neutrophils ≥ 1.0 × 10⁹/L; blasts 0% PR: BM blasts decreased by ≥ 50% but still > 5%; peripheral blood as for CR mCR: BM ≤ 5% myeloblasts and decrease by ≥ 50% HI: Any of the following: •Hemoglobin increase by ≥ 1.5 g/dL or reduction of units of red blood cell (RBC) transfusions of at least 4 RBC transfusions/8 weeks compared with pretreatment •Absolute increase in platelets of ≥ 30 × 10⁹/L if pretreatment value > 20 × 10⁹/L or increase from < 20 × 10⁹/L to > 20 × 10⁹/L and by at least 100% •At least 100% increase in neutrophils and an absolute increase of > 0.5 × 10⁹/L | Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 239 days (AZA) and 215 days (DUR) in the AZA + DUR group and 210 days in the AZA alone group. |
| AML Cohort: Overall Response Rate | Overall response rate for AML is defined as the percentage of participants achieving an overall response of morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) based on modified IWG 2003 response criteria for AML and central review. CR: The following conditions must be met: •Absolute neutrophil count (ANC) ≥ 1.0 x10⁹/L •Platelet count ≥ 100 x10⁹/L •The bone marrow should contain less than 5% blast cells; •Auer rods should not be detectable; •No platelet, or whole blood transfusions for 7days prior to the date of the hematology assessment. CRi: Defined as a morphologic complete remission but the ANC count may be < 1.0 x10⁹/L and/or the platelet count may be < 100 x10⁹/L. | Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 198 days (AZA) and 171 days (DUR) in the AZA + DUR group and 203 days in the AZA alone group. |
| Measure | Description | Time Frame |
|---|---|---|
| MDS Cohort: Kaplan Meier Estimate of Time to First Response | Time to first response is defined as the time from randomization to the earliest date any response (complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI)) based on International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who did not achieve any defined response were censored at the date of last adequate response assessment, disease progression, or death, whichever occurred first. Response was assessed following every 3 treatment cycles until treatment discontinuation. |
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Inclusion Criteria:
For both cohorts:
Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Female subjects of childbearing potential may participate, providing they meet the following conditions:
Male subject must:
Understand and voluntarily sign a biomarker-specific component of the informed consent form prior to any study-related procedures conducted.
Willing and able to adhere to the study visit schedule and other protocol requirements.
MDS Cohort:
Age ≥ 18 years at the time of signing the informed consent form.
Central confirmation of diagnosis of previously untreated primary or secondary myelodysplastic syndromes (MDS) as per World Health Organization (WHO) classification. Results of central pathology review are required prior to receiving the first dose of IP.
Central confirmation of the categorization of the MDS risk classification, as per the Revised - International prognostic scoring system (IPSS-R) Intermediate risk with >10% blasts or poor or very poor cytogenetics, or IPSS-R High or Very High risk (results of central pathology review required prior to receiving the first dose of IP).
Acute myeloid leukemia (AML) Cohort:
Age ≥ 65 years at the time of signing the informed consent form (ICF).
Central confirmation of diagnosis of one of the following untreated AML as per WHO classification:
Central confirmation of intermediate or poor risk status, based on Cytogenetics for acute myeloid leukemia.
Exclusion Criteria:
For both cohorts:
Prior hematopoietic stem cell transplant.
Considered eligible for hematopoietic stem cell transplant (allogeneic or autologous) at the time of signing the ICF.
Prior exposure to azacitidine, decitabine or prior exposure to the investigational oral formulation of decitabine, or other oral azacitidine derivative.
Inaspirable bone marrow.
Use of any of the following within 28 days prior to the first dose of IP:
Prior history of malignancies (except MDS for AML subjects), unless the subject has been free of the disease for ≥ 2 years. However, subjects with the following history/concurrent conditions are allowed:
Pregnant or breast-feeding females or females who intend to become pregnant during study participation.
Subject has active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease [exclude only if active within the last 6 months prior to signing the ICF], or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
Significant active cardiac disease within the previous 6 months prior to signing the ICF, including:
Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment), uncontrolled hypertension, cardiac arrhythmia, pneumonitis, interstitial lung disease, active peptic ulcer disease or gastritis that would limit compliance with study requirement.
Known human immunodeficiency virus (HIV) or hepatitis C (HCV) infection, or evidence of active hepatitis B virus (HBV) infection.
Known or suspected hypersensitivity to azacitidine, mannitol, or durvalumab, its constituents, or to any other humanized monoclonal antibody.
Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
Prior anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), programmed death-1 (PD-1), or programmed death ligand-1 (PD-L1) or other immune checkpoint mAb exposure.
Other investigational monoclonal antibodies (mAbs) within 6 months prior to first dose of IP.
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion:
History of primary immunodeficiency.
Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP (NOTE: Subjects, if enrolled, should not receive live vaccine during the study and for 30 days after the last dose of durvalumab).
Unwilling or unable to complete subject reported outcome assessments without assistance or with minimal assistance from trained site personnel and/or caregiver.
Subjects who have had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia.
Presence of advanced malignant hepatic tumors.
Any of the following laboratory abnormalities:
MDS Cohort:
Any previous cytotoxic, cytostatic, hormonal, biological or immunological treatment for MDS (ESA with or without G-CSF are allowed under certain conditions, see exclusion criterion # 5).
Any investigational therapy within 28 days prior to the first dose of IP.
Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
Absolute white blood cell (WBC) count ≥ 15 × 10^9/L.
AML Cohort:
Previous cytotoxic, cytostatic, hormonal, biological or immunological treatment (ESA with or without G-CSF and iron chelating therapy and hydroxyurea are allowed under certain conditions, see exclusion criterion #5) or biologic treatment for AML.
Any investigational therapy within 28 days prior to the first dose of IP.
Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
Prior use of targeted therapy agents (eg, FLT3 inhibitors, other kinase inhibitors).
Suspected or proven acute promyelocytic leukemia (French-American-British (FAB) M3) based on morphology, immunophenotype, molecular assay, or karyotype; AML associated with t(9;22) karyotype, biphenotypic acute leukemia or AML with previous hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms.
Acute myeloid leukemia associated with inv(16), t(8;21), t(16;16), t(15;17) karyotypes or molecular evidence of such translocations if not associated with a c-Kit mutation.
Absolute WBC count ≥ 15 × 10^⁹/L (NOTE: Hydroxyurea is not allowed to attain a WBC count ≤ 15 x 10⁹/L).
Known history or presence of Sweet Syndrome at screening
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| Name | Affiliation | Role |
|---|---|---|
| CL Beach, Pharm D | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06520 | United States | ||
| Georgetown University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40546817 | Derived | Bewersdorf JP, Hasle V, Shallis RM, Thompson E, Lopes de Menezes D, Rose S, Boss I, Mendez L, Podoltsev N, Stahl M, Kewan T, Halene S, Haferlach T, Fox BA, Zeidan AM. Integrated Immune Landscape Analysis of RNA Splicing Factor-Mutant AML and Higher risk MDS Treated with Azacitidine +/- Durvalumab. Ther Adv Hematol. 2025 Jun 21;16:20406207251347344. doi: 10.1177/20406207251347344. eCollection 2025. | |
| 38883163 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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Within each cohort participants were randomized in a 1:1 ratio to receive either azacitidine plus durvalumab or azacitidine alone. Randomization was stratified according to cytogenetic risk: • Very good, good and intermediate versus poor and very poor for MDS • Intermediate versus poor for AML .
This study consisted of 2 cohorts: • Adults with previously untreated intermediate, high or very high risk myelodysplastic syndromes (MDS) not eligible for hematopoietic stem cell transplantation (HSCT). • Adults with previously untreated acute myeloid leukemia (AML) ≥ 65 years and not eligible for HSCT with intermediate or poor cytogenetic risk.
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| ID | Title | Description |
|---|---|---|
| FG000 | MDS: Azacitidine + Durvalumab | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 5, 2019 | Oct 17, 2019 |
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| Durvalumab | Biological | Administered by intravenous infusion on Day 1 of every 4-week treatment cycle. |
|
|
| From randomization to the earliest date any response (up to approximately 34 months) |
| MDS Cohort: Kaplan Meier Estimate of Relapse-free Survival | Relapse-free survival is defined as the time from the date of first documented response (complete remission (CR), partial remission (PR)) to the date of disease relapse or death from any cause, whichever occurred first according to the International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Participants who received a subsequent therapy before the date of disease relapse or death were censored at the time of subsequent therapy. Relapse after CR or PR is defined as at least one of the following: •Return to pretreatment bone marrow blast % •Decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets •Reduction in hemoglobin concentration by ≥ 1.5 g/dL or transfusion dependence. Response was assessed following every 3 treatment cycles until treatment discontinuation. | From randomization to to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months) |
| MDS Cohort: Percentage of Participants Who Achieved a Cytogenetic Response | Cytogenetic response is defined as the percentage of participants who achieved a complete cytogenetic response or partial cytogenetic response according to the International Working Group (IWG) 2006 response criteria and central review. Complete cytogenetic response: Disappearance of the baseline chromosomal abnormality without appearance of new abnormalities. Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Response was assessed following every 3 treatment cycles until treatment discontinuation. | From randomization up to approximately 34 months |
| MDS Cohort: Kaplan-Meier Estimate of Progression-free Survival (PFS) | Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD), relapse, or death due to any cause during or after the treatment period, whichever occurred first, according to the International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Progressive disease is defined as follows: - an increase in BM blasts relative to nadir: •If nadir less than 5% blasts: ≥ 50% increase in blasts to > 5% blasts •If nadir 5% - 10% blasts: ≥ 50% increase in blasts to > 10% blasts •If nadir 10% - 20% blasts: ≥ 50% increase in blasts to > 20% blasts •If nadir 20% - 30% blasts: ≥ 50% increase in blasts to > 30% blasts And any of the following: •At least 50% decrement from maximum remission/response levels in granulocytes or platelets •Reduction in Hgb concentration by ≥ 2 g/dL •Transfusion dependence | From randomization to the first documented progressive disease (PD), relapse, or death due to any cause (up to approximately 34 months) |
| MDS Cohort: Kaplan-Meier Estimate of Duration of Response | Duration of response is defined as the time from when the first overall response (complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI)) was observed until relapse, progressive disease (PD), or death, as defined by the International Working Group (IWG) 2006 response criteria and central review. If no relapse, PD, or death was observed, the duration of response was censored at the last response assessment date that the participant was known to be progression-free. Response was assessed following every 3 treatment cycles until treatment discontinuation. | From randomization to the first overall response, or death (up to approximately 34 months) |
| MDS Cohort: Kaplan-Meier Estimate of Time to AML Transformation | Participants were monitored for transformation to acute myeloid leukemia (AML) until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial. Time to transformation to AML is defined as the time from the date of randomization until the date the participant had documented transformation to AML (defined as at least 30% of myeloblasts in the bone marrow). Participants with no transformation to AML were censored at the date of their last disease assessment. | From randomization to the date the participant had documented transformation to AML (up to approximately 34 months) |
| MDS Cohort: Percentage of Participants With Disease Transformation to AML | Disease transformation to acute myeloid leukemia (AML) is defined as at least 30% myeloblasts in the bone marrow. Participants were monitored for transformation to AML until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial. Participants with no transformation to AML were censored at the date of their last disease assessment. | From randomization until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial (up to approximately 34 months) |
| AML Cohort: Kaplan Meier Estimate of Time to First Response | Time to first response is defined as the time between the date of randomization and the earliest date any response (CR or CRi) was observed based on the modified International Working Group (IWG) 2003 response criteria for AML and central review. Participants who did not achieve any defined response were censored at the date of last adequate response assessment, disease progression, or death, whichever occurred first. Response was assessed following every 3 treatment cycles until treatment discontinuation. | From randomization and the earliest date any response (up to approximately 34 months) |
| AML Cohort: Kaplan Meier Estimate of Relapse-free Survival | Relapse-free survival is defined as time from the date of first documented response (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi)) to the date of disease relapse or death from any cause, whichever occurred first based on the modified International Working Group (IWG) 2003 response criteria for AML and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Participants who received a subsequent therapy before the date of disease relapse or death were censored at the time of subsequent therapy. | From randomization to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months) |
| AML Cohort: Percentage of Participants Who Achieved a Complete Cytogenetic Response | Complete cytogenetic response (CyCR) based on the modified International Working Group (IWG) 2003 response criteria is defined as morphologic complete remission with a reversion to a normal karyotype. The following conditions must be met: • Absolute neutrophil count (ANC) ≥ 1.0 x10⁹/L • Platelet count ≥ 100 x10⁹/L • The bone marrow should contain less than 5% blast cells; • Auer rods should not be detectable; • No platelet, or whole blood transfusions for 7days prior to the date of the hematology assessment. AND • Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases). Response was assessed following every 3 treatment cycles until treatment discontinuation. | From randomization up to approximately 34 months) |
| AML Cohort: Percentage of Participants With Hematologic Improvement | Hematological improvement was defined as participants with a erythroid response (HI-E), platelet response (HI-P) or neutrophil response (HI-NE) for at least 8 weeks, according to the IWG 2006 response criteria: Hi-E (in participants with pretreatment hemoglobin < 11 g/dL or red blood cell (RBC)-transfusion dependent): Hemoglobin increase of ≥ 1.5 g/dL, or reduction in units of RBC transfusions of at least 4 RBC transfusions/8 weeks compared with the 8 weeks prior to pretreatment. HI-P (in participants with pretreatment platelet count < 100 × 10⁹/L): Absolute increase in platelets of ≥ 30 × 10⁹/L if pretreatment value > 20 × 10⁹/L or increase from < 20 × 10⁹/L to > 20 × 10⁹/L and by at least 100%. HI-N (in participants with pretreatment neutrophils < 1.0 × 10⁹/L): At least 100% increase in neutrophils and an absolute increase of > 0.5 × 10⁹/L. Response was assessed following every 3 treatment cycles until treatment discontinuation. | From randomization up to approximately 34 months |
| AML Cohort: Kaplan-Meier Estimate of Duration of Response | Duration of response is defined as the time from the first response morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi)) was observed until relapse, PD, or death based on the IWG 2003 response criteria and central review. If no relapse, PD, or death was observed, the duration of response was censored at the last response assessment date that the participant was known to be progression-free. Response was assessed following every 3 treatment cycles until treatment discontinuation. | From randomization until relapse, PD, or death (up to approximately 34 months) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment emergent adverse events are adverse events (AEs) that occurred or worsened on or after the first dose of study drug (durvalumab or azacitidine) and within 90 days after last dose of durvalumab or 28 days after last dose of azacitidine. A treatment-related TEAE is a TEAE where the causal relationship was assessed by the investigator as "Suspected". The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1 (Mild): asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death due to AE. | From first dose to 90 days after last dose of durvalumab or 28 days after last dose of azacitidine proir to the extension study (up to approximately 34 months) |
| Kaplan-Meier Estimate of Overall Survival | Overall survival is defined as the time between randomization and death/censored date. Participants who were alive at the time of the clinical data cut-off were censored at the last known alive date. | From randomization to date of death or last known alive date (up to approximately 34 months) |
| One-year Survival | One-year survival is defined as the probability of survival at 1 year from randomization and is represented by the Kaplan-Meier estimate of the percentage of participants alive after 1 year. | At 12 months after randomization |
| Durvalumab Serum Concentration | Cycle 1 Day 1 end of infusion (EOI), Cycle 2 Day 1 pre-infusion, Cycle 4 Day 1 pre-infusion and EOI, and Cycle 6 Day 1 pre-infusion |
| Change From Baseline in Selected Hematology Parameters I | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
| Change From Baseline in Selected Hematology Parameters II | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
| Change From Baseline in Selected Chemistry Parameters I | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
| Change From Baseline in Selected Chemistry Parameters II | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
| Change From Baseline in Selected Chemistry Parameters III | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
| Change From Baseline in Selected Chemistry Parameters IV | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| University of Texas- MD Anderson | Houston | Texas | 77230 | United States |
| Medizinische Universitat Graz | Graz | 8036 | Austria |
| Medizinische Universitat Innsbruck | Innsbruck | 6020 | Austria |
| Elisabethinen Hospital Linz | Linz | 4020 | Austria |
| Salzburger Landkliniken St. Johanns-Spital | Salzburg | 5020 | Austria |
| Hanusch Krankenhaus der Stadt Wien | Vienna | 1140 | Austria |
| Local Institution - 653 | Vienna | 1140 | Austria |
| AKH Wien | Wein | 1090 | Austria |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| Grand Hopital de Charleroi | Charleroi | 6000 | Belgium |
| Local Institution - 202 | Ghent | 9000 | Belgium |
| UH Gent | Ghent | 9000 | Belgium |
| UH Gasthuisberg | Leuven | 3000 | Belgium |
| Cliniques Universitaires UCL de Mont-Godine | Yvoir | 5530 | Belgium |
| University of Alberta | Edmonton | Alberta | T6g2b7 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Ottawa General Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| CHUM - Notre Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Centre Hospitalier Universitaire d' Angers | Angers | 67091 | France |
| Hopital Avicenne | Bobigny | 93009 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon | La Tronche | 38700 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Local Institution - 261 | Lyon | 69008 | France |
| CHRU de Nantes - Hotel Dieu | Nantes | 44093 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Local Institution - 251 | Paris | 75010 | France |
| CHU Bordeaux | Pessac | 33604 | France |
| Local Institution - 254 | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| IUCT Oncopole | Toulouse | 31059 Cedex 9 | France |
| Local Institution - 604 | Dresden | 01307 | Germany |
| Universitatsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Local Institution - 603 | Düsseldorf | 40479 | Germany |
| Marien Hospital | Düsseldorf | 40479 | Germany |
| Universitatsklinikum Essen | Essen | 45122 | Germany |
| Klinikum der Johann Wolfgang Goethe Universitat | Frankfurt am Main | 60590 | Germany |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Medizinische Hochschule HannoverZentrum Innere Medizin | Hanover | 30625 | Germany |
| Universitatsklinikum Leipzig | Leipzig | 04103 | Germany |
| Klinikum der LMU Campus Grosshadern | München | 1307 | Germany |
| Local Institution - 605 | München | 1307 | Germany |
| Klinikum rechts der Isar der TU Munchen | München | 81675 | Germany |
| Universitatsklinikum Ulm | Ulm | 89081 | Germany |
| AO Spedali Civili di Brescia | Brecia | 25123 | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | 50134 | Italy |
| Ospedale Niguarda Milano | Milan | 20162 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello | Palermo | 33100 | Italy |
| I.R.C.C.S. Policlinico San Matteo - Universita di Pavia | Pavia | 27100 | Italy |
| Local Institution - 302 | Pavia | 27100 | Italy |
| Azienda Ospedaliera Bianchi-Melacrino-Morelli | Roma | 133 | Italy |
| Local Institution - 303 | Roma | 133 | Italy |
| Policlinico Agostino Gemelli - Istituto di Ematologia | Roma | 89100 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | 133 | Italy |
| Local Institution - 304 | Rome | 133 | Italy |
| Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine | Udine | 30174 | Italy |
| Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese | Varese | 21100 | Italy |
| VU University Medical Center | Amsterdam | 1081 HV | Netherlands |
| Oddzial Hematologii Onkologicznej Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologicz | Brzozów | 36-200 | Poland |
| Katedra i Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne | Gdansk | 80-211 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku | Lubin | 20-081 | Poland |
| Oddzial Hematologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW | Olsztyn | 10-228 | Poland |
| Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku | Wroclaw | 50-367 | Poland |
| Hospitais da Universidade de Coimbra | Coimbra | 3000-076 | Portugal |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE | Lisbon | 1099-023 | Portugal |
| Ipo Instituto Portugues De Oncologia Porto | Porto | 4200-072 | Portugal |
| Local Institution - 502 | Porto | 4200-072 | Portugal |
| Hospital de Sao Joao | Porto | 4200 | Portugal |
| Hospital Universitario Vall D hebron | Barcelona | 28040 | Spain |
| Hospital Clinic I Provincial de Barcelona | Barcelona | 8036 | Spain |
| Complejo Hospitalario San Pedro de Alcantara | Cáceres | 10003 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Gregorio Maranon | Madrid | 37007 | Spain |
| Local Institution - 555 | Madrid | 37007 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | 7198 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitario La Fe | Valencia | 46009 | Spain |
| Local Institution - 559 | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| University Hospital Birmingham | Birmingham | B15 2TH | United Kingdom |
| St James University Hospital | Leeds | LS1 3EX | United Kingdom |
| St Bartholomews Hospital | London | EC1 7BE | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| University College London Hospital | London Bloomsbury | WC1E 6AU | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Local Institution - 453 | Oxford | OX3 9DU | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Zeidan AM, Bewersdorf JP, Hasle V, Shallis RM, Thompson E, de Menezes DL, Rose S, Boss I, Halene S, Haferlach T, Fox BA. Integrated genetic, epigenetic, and immune landscape of TP53 mutant AML and higher risk MDS treated with azacitidine. Ther Adv Hematol. 2024 Jun 15;15:20406207241257904. doi: 10.1177/20406207241257904. eCollection 2024. |
| 34972214 | Derived | Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Ogasawara K, Cavenagh J, Silverman LR, Voso MT, Hellmann A, Tormo M, O'Connor T, Previtali A, Rose S, Garcia-Manero G. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for higher-risk myelodysplastic syndromes. Blood Adv. 2022 Apr 12;6(7):2207-2218. doi: 10.1182/bloodadvances.2021005487. |
| 34933333 | Derived | Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Hellmann A, Taussig DC, Tormo M, Voso MT, Cavenagh J, O'Connor T, Previtali A, Rose S, Silverman LR. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for older patients with AML. Blood Adv. 2022 Apr 12;6(7):2219-2229. doi: 10.1182/bloodadvances.2021006138. |
| BMS Clinical Trial Patient Recruiting | View source |
| FG001 | MDS: Azacitidine Alone | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| FG002 | AML: Azacitidine + Durvalumab | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| FG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants (intent-to-treat population)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MDS: Azacitidine + Durvalumab | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| BG001 | MDS: Azacitidine Alone | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| BG002 | AML: Azacitidine + Durvalumab | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| BG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
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| Age, Continuous | Data were collected and reported separately for each cohort. | Mean | Standard Deviation | years |
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| Age, Customized | Data were collected and reported separately for each cohort. | Count of Participants | Participants |
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| Sex: Female, Male | Data were collected and reported separately for each cohort. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Data were collected and reported separately for each cohort. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Data were collected and reported separately for each cohort. | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: - 0 = Fully active, no restrictions; - 1 = Restricted activity but ambulatory, able to carry out work of a light nature; - 2 = Ambulatory and capable of all self-care but unable to carry out work activities; - 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; - 4 = Completely disabled, no selfcare, confined to bed or chair; - 5 = Dead | Data were collected and reported separately for each cohort. | Count of Participants | Participants |
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| Revised International Prognostic Scoring System (IPSS-R) Cytogenetic Risk Groups (MDS Cohort) | The IPSS-R cytogenetic risk score is based on cytogenetic (chromosomal) abnormalities observed in the bone marrow cells. A good cytogenetic prognosis predicts longer survival and lower transformation to leukemia. | Participants in the MDS cohort only | Count of Participants | Participants |
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| Cytogenetic Risk Classifications (AML Cohort) | Cytogenetic risk classification according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Myeloid Leukemia. Risk categories are based on analysis of cytogenetics (the study of chromosomes), including chromosomal deletions, duplications, or substitutions and analysis of molecular abnormalities such as specific mutations. Better risk indicates disease more likely to respond to initial treatment and less likely to relapse whereas poor-risk is characterized by poor response to induction chemotherapy and higher relapse rates. | Participants in the AML cohort only | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | MDS Cohort: Overall Response Rate | Overall response rate (ORR) is defined as the percentage of participants achieving a complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI) based on International Working Group (IWG) 2006 response criteria for MDS and central review. CR: ≤ 5% myeloblasts in bone marrow (BM), and peripheral blood: hemoglobin ≥ 11 g/dL; platelets ≥ 100 × 10⁹/L; neutrophils ≥ 1.0 × 10⁹/L; blasts 0% PR: BM blasts decreased by ≥ 50% but still > 5%; peripheral blood as for CR mCR: BM ≤ 5% myeloblasts and decrease by ≥ 50% HI: Any of the following: •Hemoglobin increase by ≥ 1.5 g/dL or reduction of units of red blood cell (RBC) transfusions of at least 4 RBC transfusions/8 weeks compared with pretreatment •Absolute increase in platelets of ≥ 30 × 10⁹/L if pretreatment value > 20 × 10⁹/L or increase from < 20 × 10⁹/L to > 20 × 10⁹/L and by at least 100% •At least 100% increase in neutrophils and an absolute increase of > 0.5 × 10⁹/L | All randomized participants in the MDS cohort; participants who discontinued before 6 cycles of treatment without achieving overall response were counted as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 239 days (AZA) and 215 days (DUR) in the AZA + DUR group and 210 days in the AZA alone group. |
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| Primary | AML Cohort: Overall Response Rate | Overall response rate for AML is defined as the percentage of participants achieving an overall response of morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) based on modified IWG 2003 response criteria for AML and central review. CR: The following conditions must be met: •Absolute neutrophil count (ANC) ≥ 1.0 x10⁹/L •Platelet count ≥ 100 x10⁹/L •The bone marrow should contain less than 5% blast cells; •Auer rods should not be detectable; •No platelet, or whole blood transfusions for 7days prior to the date of the hematology assessment. CRi: Defined as a morphologic complete remission but the ANC count may be < 1.0 x10⁹/L and/or the platelet count may be < 100 x10⁹/L. | All randomized participants in the AML cohort; participants who discontinued before 6 cycles of treatment without achieving overall response were counted as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 198 days (AZA) and 171 days (DUR) in the AZA + DUR group and 203 days in the AZA alone group. |
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| Secondary | MDS Cohort: Kaplan Meier Estimate of Time to First Response | Time to first response is defined as the time from randomization to the earliest date any response (complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI)) based on International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who did not achieve any defined response were censored at the date of last adequate response assessment, disease progression, or death, whichever occurred first. Response was assessed following every 3 treatment cycles until treatment discontinuation. | All participants randomized in the MDS cohort | Posted | Median | 95% Confidence Interval | Weeks | From randomization to the earliest date any response (up to approximately 34 months) |
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| Secondary | MDS Cohort: Kaplan Meier Estimate of Relapse-free Survival | Relapse-free survival is defined as the time from the date of first documented response (complete remission (CR), partial remission (PR)) to the date of disease relapse or death from any cause, whichever occurred first according to the International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Participants who received a subsequent therapy before the date of disease relapse or death were censored at the time of subsequent therapy. Relapse after CR or PR is defined as at least one of the following: •Return to pretreatment bone marrow blast % •Decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets •Reduction in hemoglobin concentration by ≥ 1.5 g/dL or transfusion dependence. Response was assessed following every 3 treatment cycles until treatment discontinuation. | Participants randomized in the MDS cohort who had a CR or PR | Posted | Median | 95% Confidence Interval | Months | From randomization to to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months) |
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| Secondary | MDS Cohort: Percentage of Participants Who Achieved a Cytogenetic Response | Cytogenetic response is defined as the percentage of participants who achieved a complete cytogenetic response or partial cytogenetic response according to the International Working Group (IWG) 2006 response criteria and central review. Complete cytogenetic response: Disappearance of the baseline chromosomal abnormality without appearance of new abnormalities. Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Response was assessed following every 3 treatment cycles until treatment discontinuation. | Participants randomized in the MDS cohort evaluable for cytogenetic response (ie, participants with baseline cytogenetic abnormalities). | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to approximately 34 months |
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| Secondary | MDS Cohort: Kaplan-Meier Estimate of Progression-free Survival (PFS) | Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD), relapse, or death due to any cause during or after the treatment period, whichever occurred first, according to the International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Progressive disease is defined as follows: - an increase in BM blasts relative to nadir: •If nadir less than 5% blasts: ≥ 50% increase in blasts to > 5% blasts •If nadir 5% - 10% blasts: ≥ 50% increase in blasts to > 10% blasts •If nadir 10% - 20% blasts: ≥ 50% increase in blasts to > 20% blasts •If nadir 20% - 30% blasts: ≥ 50% increase in blasts to > 30% blasts And any of the following: •At least 50% decrement from maximum remission/response levels in granulocytes or platelets •Reduction in Hgb concentration by ≥ 2 g/dL •Transfusion dependence | All participants randomized in the MDS cohort (PFS was a pre-specified secondary outcome measure in the MDS cohort only). | Posted | Median | 95% Confidence Interval | Months | From randomization to the first documented progressive disease (PD), relapse, or death due to any cause (up to approximately 34 months) |
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| Secondary | MDS Cohort: Kaplan-Meier Estimate of Duration of Response | Duration of response is defined as the time from when the first overall response (complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI)) was observed until relapse, progressive disease (PD), or death, as defined by the International Working Group (IWG) 2006 response criteria and central review. If no relapse, PD, or death was observed, the duration of response was censored at the last response assessment date that the participant was known to be progression-free. Response was assessed following every 3 treatment cycles until treatment discontinuation. | Participants randomized in the MDS cohort with an overall response (CR, mCR, PR, or HI) | Posted | Median | 95% Confidence Interval | Weeks | From randomization to the first overall response, or death (up to approximately 34 months) |
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| Secondary | MDS Cohort: Kaplan-Meier Estimate of Time to AML Transformation | Participants were monitored for transformation to acute myeloid leukemia (AML) until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial. Time to transformation to AML is defined as the time from the date of randomization until the date the participant had documented transformation to AML (defined as at least 30% of myeloblasts in the bone marrow). Participants with no transformation to AML were censored at the date of their last disease assessment. | All participants randomized in the MDS cohort. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date the participant had documented transformation to AML (up to approximately 34 months) |
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| Secondary | MDS Cohort: Percentage of Participants With Disease Transformation to AML | Disease transformation to acute myeloid leukemia (AML) is defined as at least 30% myeloblasts in the bone marrow. Participants were monitored for transformation to AML until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial. Participants with no transformation to AML were censored at the date of their last disease assessment. | All participants randomized in the MDS cohort | Posted | Number | Percentage of participants | From randomization until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial (up to approximately 34 months) |
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| Secondary | AML Cohort: Kaplan Meier Estimate of Time to First Response | Time to first response is defined as the time between the date of randomization and the earliest date any response (CR or CRi) was observed based on the modified International Working Group (IWG) 2003 response criteria for AML and central review. Participants who did not achieve any defined response were censored at the date of last adequate response assessment, disease progression, or death, whichever occurred first. Response was assessed following every 3 treatment cycles until treatment discontinuation. | All participants randomized in the AML cohort | Posted | Median | 95% Confidence Interval | Weeks | From randomization and the earliest date any response (up to approximately 34 months) |
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| Secondary | AML Cohort: Kaplan Meier Estimate of Relapse-free Survival | Relapse-free survival is defined as time from the date of first documented response (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi)) to the date of disease relapse or death from any cause, whichever occurred first based on the modified International Working Group (IWG) 2003 response criteria for AML and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Participants who received a subsequent therapy before the date of disease relapse or death were censored at the time of subsequent therapy. | Participants randomized in the AML cohort with a response (CR or CRi) | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months) |
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| Secondary | AML Cohort: Percentage of Participants Who Achieved a Complete Cytogenetic Response | Complete cytogenetic response (CyCR) based on the modified International Working Group (IWG) 2003 response criteria is defined as morphologic complete remission with a reversion to a normal karyotype. The following conditions must be met: • Absolute neutrophil count (ANC) ≥ 1.0 x10⁹/L • Platelet count ≥ 100 x10⁹/L • The bone marrow should contain less than 5% blast cells; • Auer rods should not be detectable; • No platelet, or whole blood transfusions for 7days prior to the date of the hematology assessment. AND • Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases). Response was assessed following every 3 treatment cycles until treatment discontinuation. | Participants randomized in the AML cohort evaluable for cytogenetic response (ie participants with baseline cytogenetic abnormalities). | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization up to approximately 34 months) |
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| Secondary | AML Cohort: Percentage of Participants With Hematologic Improvement | Hematological improvement was defined as participants with a erythroid response (HI-E), platelet response (HI-P) or neutrophil response (HI-NE) for at least 8 weeks, according to the IWG 2006 response criteria: Hi-E (in participants with pretreatment hemoglobin < 11 g/dL or red blood cell (RBC)-transfusion dependent): Hemoglobin increase of ≥ 1.5 g/dL, or reduction in units of RBC transfusions of at least 4 RBC transfusions/8 weeks compared with the 8 weeks prior to pretreatment. HI-P (in participants with pretreatment platelet count < 100 × 10⁹/L): Absolute increase in platelets of ≥ 30 × 10⁹/L if pretreatment value > 20 × 10⁹/L or increase from < 20 × 10⁹/L to > 20 × 10⁹/L and by at least 100%. HI-N (in participants with pretreatment neutrophils < 1.0 × 10⁹/L): At least 100% increase in neutrophils and an absolute increase of > 0.5 × 10⁹/L. Response was assessed following every 3 treatment cycles until treatment discontinuation. | All participants randomized in the AML cohort (the percentage of participants with hematologic improvement was a pre-specified secondary endpoint for the AML cohort only). | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization up to approximately 34 months |
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| Secondary | AML Cohort: Kaplan-Meier Estimate of Duration of Response | Duration of response is defined as the time from the first response morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi)) was observed until relapse, PD, or death based on the IWG 2003 response criteria and central review. If no relapse, PD, or death was observed, the duration of response was censored at the last response assessment date that the participant was known to be progression-free. Response was assessed following every 3 treatment cycles until treatment discontinuation. | Participants randomized in the AML cohort with an objective response (CR or CRi) | Posted | Median | 95% Confidence Interval | Weeks | From randomization until relapse, PD, or death (up to approximately 34 months) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment emergent adverse events are adverse events (AEs) that occurred or worsened on or after the first dose of study drug (durvalumab or azacitidine) and within 90 days after last dose of durvalumab or 28 days after last dose of azacitidine. A treatment-related TEAE is a TEAE where the causal relationship was assessed by the investigator as "Suspected". The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1 (Mild): asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death due to AE. | All participants who received at least 1 dose of any study drug. | Posted | Count of Participants | Participants | From first dose to 90 days after last dose of durvalumab or 28 days after last dose of azacitidine proir to the extension study (up to approximately 34 months) |
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| Secondary | Kaplan-Meier Estimate of Overall Survival | Overall survival is defined as the time between randomization and death/censored date. Participants who were alive at the time of the clinical data cut-off were censored at the last known alive date. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to date of death or last known alive date (up to approximately 34 months) |
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| Secondary | One-year Survival | One-year survival is defined as the probability of survival at 1 year from randomization and is represented by the Kaplan-Meier estimate of the percentage of participants alive after 1 year. | All randomized participants | Posted | Number | Percentage of participants | At 12 months after randomization |
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| Secondary | Durvalumab Serum Concentration | Participants who received at least one dose of durvalumab and who had at least 1 measurable durvalumab concentration value and with available data at each time point. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 1 end of infusion (EOI), Cycle 2 Day 1 pre-infusion, Cycle 4 Day 1 pre-infusion and EOI, and Cycle 6 Day 1 pre-infusion |
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| Secondary | Change From Baseline in Selected Hematology Parameters I | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | All treated participants with both non-missing baseline and postbaseline values | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
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| Secondary | Change From Baseline in Selected Hematology Parameters II | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | All treated participants with both non-missing baseline and postbaseline values | Posted | Mean | Standard Deviation | g/L | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
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| Secondary | Change From Baseline in Selected Chemistry Parameters I | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | All treated participants with both non-missing baseline and postbaseline values | Posted | Mean | Standard Deviation | g/L | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
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| Secondary | Change From Baseline in Selected Chemistry Parameters II | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | All treated participants with both non-missing baseline and postbaseline values | Posted | Mean | Standard Deviation | U/L | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
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| Secondary | Change From Baseline in Selected Chemistry Parameters III | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | All treated participants with both non-missing baseline and postbaseline values | Posted | Mean | Standard Deviation | mmol/L | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
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| Secondary | Change From Baseline in Selected Chemistry Parameters IV | Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose. | All treated participants with both non-missing baseline and postbaseline values | Posted | Mean | Standard Deviation | umol/L | Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22) |
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All-cause mortality was assessed from the participants first dose to their study completion (up to approximately 66 months) SAEs and Other AEs were assessed from first dose to 90 days after last dose of durvalumab or 28 days after last dose of azacitidine (up to approximately 66 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | MDS: Azacitidine + Durvalumab | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. | 22 | 38 | 34 | 38 | 38 | 38 |
| EG001 | MDS: Azacitidine Alone | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. | 27 | 41 | 29 | 41 | 40 | 41 |
| EG002 | AML: Azacitidine + Durvalumab | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. | 48 | 64 | 56 | 64 | 63 | 64 |
| EG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. | 42 | 62 | 45 | 62 | 60 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
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| Cytopenia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | 21.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | 21.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | 21.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | 21.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | 21.1 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | 21.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | 21.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 21.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | 21.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | 21.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 21.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 21.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 21.1 | Systematic Assessment |
| |
| Granuloma | General disorders | 21.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | 21.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | 21.1 | Systematic Assessment |
| |
| Injection site vesicles | General disorders | 21.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 21.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 21.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 21.1 | Systematic Assessment |
| |
| Sudden death | General disorders | 21.1 | Systematic Assessment |
| |
| Cellulitis | General disorders | 21.1 | Systematic Assessment | Cellulitis of the right axillary region and respiratory distress |
|
| Cholecystitis | Hepatobiliary disorders | 21.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | 21.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | 21.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | 21.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Injection site infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Micrococcus infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Oesophageal infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Perineal cellulitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Serratia sepsis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 21.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.1 | Systematic Assessment |
| |
| Transformation to acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.1 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 21.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 21.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | 21.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 21.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 21.1 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | 21.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | 21.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | 21.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 21.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | 21.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | 21.1 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | 21.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | 21.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 21.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 21.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 21.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 21.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | 21.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 21.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 21.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 21.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | 21.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | 21.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | 21.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | 21.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | 21.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 21.1 | Systematic Assessment |
| |
| Oedema | General disorders | 21.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 21.1 | Systematic Assessment |
| |
| Pain | General disorders | 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 21.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 21.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | 21.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 21.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 21.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 21.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 21.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 21.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 21.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 21.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 21.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | 21.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 21.1 | Systematic Assessment |
|
Protocol Amendment 03 was introduced on 05 Mar 2019. At the Investigator's discretion, participants meeting all the continuation criteria were eligible to enter the optional extension phase to continue to benefit from treatment with subcutaneous azacitidine and/or durvalumab. Participants started the extension phase at the time of their next regularly scheduled dosing cycle for study drug azacitidine or azacitidine and durvalumab.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2017 | Oct 17, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C000613593 | durvalumab |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
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| AML |
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| AML Cohort |
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| AML Cohort |
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| AML Cohort |
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| AML Cohort |
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| AML Cohort |
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| OG001 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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| OG001 | MDS: Azacitidine Alone | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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| OG001 | MDS: Azacitidine Alone | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
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| OG001 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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| OG001 | MDS: Azacitidine Alone | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| OG002 | AML: Azacitidine + Durvalumab | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
| OG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
| OG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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| OG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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| Participants |
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Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
| OG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
| OG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
| OG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
| OG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
| OG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
| OG003 | AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. |
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| ≥ 75 years |
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| Unknown or Not Reported |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Not Collected or Reported |
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| Other |
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| 2 - Ambulatory but unable to work |
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| 3 - Limited self-care |
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| 4 - Completely Disabled |
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