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Business decision to terminate the development of alvocidib program on 17 November 2020. Patients permitted on treatment until April 22, 2021. The last end-of-treatment follow-up completed on May 14, 2021.
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This study will evaluate the safety and efficacy of alvocidib in patients with AML who have either relapsed from or are refractory to venetoclax in combination with azacytidine or decitabine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead-In Cohort: Arm 1 | Experimental | Refractory (i.e., failed to achieve a CR/CRi or achieved a CR/CRi with duration <90 days) |
|
| Lead-In Cohort: Arm 2 | Experimental | Relapsed (i.e., reoccurrence of disease following a CR/CRi with duration ≥90 days). |
|
| Stage 1: Arm 1 | Experimental | Refractory (i.e., failed to achieve a CR/CRi or achieved a CR/CRi with duration <90 days) |
|
| Stage 1: Arm 2 | Experimental | Relapsed (i.e., reoccurrence of disease following a CR/CRi with duration ≥90 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alvocidib (flavopiridol) and cytarabine (Ara-C) | Drug | Alvocidib (flavopiridol), administered intravenously, + cytarabine (Ara-C), administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined Complete Remission | Rate of combined complete remission (complete remission (CR) + CR with incomplete hematological recovery (CRi)), as defined by the International Working Group Criteria and 2017 European LeukemiaNet). Combined complete remissions (patients with a best response of CR or CRi), complete remissions, composite complete remissions (patients with a best response of CR, CRi or CRh), and combined responses (patients with a best response of CR, CRi, CRh, MLFS or PR) will be summarized by observed response rates and estimated 95% CIs. | Response assessments were measured from date of first dose through End of Treatment date, an average of 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival | Time from treatment (Day 1) until death from any cause | From first dose until disease progression or death; through study termination, an average of 10 months |
| Complete Response Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Anthony, DO | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Medical Providers | Clovis | California | 93611 | United States | ||
| City of Hope National Medical Center, City of Hope Medical Center |
A safety lead-in cohort comprised of 6 patients (3 patients in each treatment arm) were treated and evaluated for dose-limiting toxicities (DLTs) prior to enrolling patients in Stage 1. (Seven patients were enrolled but only 6 were considered evaluable.) If a DLT was observed, dose de-escalation occurred, and if no DLTs were observed, randomization into Stage 1 would commence.
Eleven subjects were enrolled between January 2020 and November 2020
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lead-In Cohort: Arm 1 | ALDAC: Alvocidib administered intravenously on days 1 and 15 + cytarabine administered by subcutaneous injection days 3-12 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
| FG001 | Lead-In Cohort: Arm 2 |
| 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 | Aug 11, 2020 | Jun 1, 2022 |
Not provided
Not provided
Randomized, Two-stage
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Not provided
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| Alvocidib (flavopiridol) | Drug | Administered intravenously |
|
Percentage of patients achieving complete response (CR) whose bone marrow is determined to be negative for minimal residual disease (MRD) using standardized techniques (ie, multiparametric flow cytometry [MPFC] and molecular testing including next generation sequencing [NGS]
| Response assessments were measured from date of first dose through end of treatment date, an average of 3 months |
| Composite CR Rate | Patients with a best response of CR + CRi + CRh (CR + partial recovery of both blood cell types) | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months |
| Combined Response Rate | Combined Percentage of Patients Achieving One of the Following: CR < CRi, CRh, MLFS, PR Morphologic leukemia-free state (MLFS) = Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Response (PR) = Meets all hematologic values required for CR but with a decrease of at least 50% in the percentage of blasts to ≥5% to ≤25% in bone marrow | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months |
| Event Free Survival (EFS) | Event Free Survival - time from first treatment (D1) until (a) treatment failure, (b) relapse after CR/Cri or CRh, or (c) death from any cause, whichever occurs first | From first dose until disease progression or death; through study termination, an average of 10 months |
| Duration of Composite Complete Remission (CR) | Duration of Composite CR, defined as the time from first documented response of CR, CRi or CRhi to relapse or death from any cause | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months |
| Transfusion Independence | Rates of 28- and 56-day Transfusion Independence (TI) = Percentages of patients who do not receive red blood cell (RBC) transfusions, platelet (PLT) transfusions, and neither RBC nor PLT transfusions for 28 and 56 days; comprised of 6 secondary endpoints | Transfusion dependence was measured from 28 days prior to first dose through 56 days after last dose, an average of 6 months |
| Duarte |
| California |
| 91010 |
| United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| University of California, San Francisco Medical Center | San Francisco | California | 94143 | United States |
| Advent Health Medical Group Blood & Marrow Transplant at Orlando | Orlando | Florida | 32804 | United States |
| Orlando Health, Inc, Univ of Florida Health Cancer Center | Orlando | Florida | 32806 | United States |
| Indiana Blood and Marrow Translplantation - Clinic | Indianapolis | Indiana | 46237 | United States |
| University of Kansas Medical Center | Westwood | Kansas | 66205 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87106 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Columbia University Medical Center | New York | New York | 10027 | United States |
| University of North Carolina (UNC) | Chapel Hill | North Carolina | 27599 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health & Sciences University - Knight Cancer Institute - Center for Hematologic Malignancies | Portland | Oregon | 97239 | United States |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | United States |
| Baylor University Center | Dallas | Texas | 75211 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
| FG002 | Stage 1: Arm 1 | ALDAC: Alvocidib administered intravenously on days 1 and 15 + cytarabine administered by subcutaneous injection days 3-12 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
| FG003 | Stage 1: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lead-In Cohort: Arm 1 | ALDAC: Alvocidib administered intravenously on days 1 and 15 + cytarabine administered by subcutaneous injection days 3-12 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
| BG001 | Lead-In Cohort: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
| BG002 | Stage 1: Arm 1 | ALDAC: Alvocidib administered intravenously on days 1 and 15 + cytarabine administered by subcutaneous injection days 3-12 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
| BG003 | Stage 1: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Combined Complete Remission | Rate of combined complete remission (complete remission (CR) + CR with incomplete hematological recovery (CRi)), as defined by the International Working Group Criteria and 2017 European LeukemiaNet). Combined complete remissions (patients with a best response of CR or CRi), complete remissions, composite complete remissions (patients with a best response of CR, CRi or CRh), and combined responses (patients with a best response of CR, CRi, CRh, MLFS or PR) will be summarized by observed response rates and estimated 95% CIs. | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | Posted | Response assessments were measured from date of first dose through End of Treatment date, an average of 3 months. |
|
| ||||||||||||||||||||||||||||
| Secondary | Median Overall Survival | Time from treatment (Day 1) until death from any cause | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | Posted | From first dose until disease progression or death; through study termination, an average of 10 months |
| |||||||||||||||||||||||||||||
| Secondary | Complete Response Rate | Percentage of patients achieving complete response (CR) whose bone marrow is determined to be negative for minimal residual disease (MRD) using standardized techniques (ie, multiparametric flow cytometry [MPFC] and molecular testing including next generation sequencing [NGS] | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | Posted | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months |
| |||||||||||||||||||||||||||||
| Secondary | Composite CR Rate | Patients with a best response of CR + CRi + CRh (CR + partial recovery of both blood cell types) | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | Posted | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months |
| |||||||||||||||||||||||||||||
| Secondary | Combined Response Rate | Combined Percentage of Patients Achieving One of the Following: CR < CRi, CRh, MLFS, PR Morphologic leukemia-free state (MLFS) = Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Response (PR) = Meets all hematologic values required for CR but with a decrease of at least 50% in the percentage of blasts to ≥5% to ≤25% in bone marrow | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | Posted | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months |
| |||||||||||||||||||||||||||||
| Secondary | Event Free Survival (EFS) | Event Free Survival - time from first treatment (D1) until (a) treatment failure, (b) relapse after CR/Cri or CRh, or (c) death from any cause, whichever occurs first | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | Posted | From first dose until disease progression or death; through study termination, an average of 10 months |
| |||||||||||||||||||||||||||||
| Secondary | Duration of Composite Complete Remission (CR) | Duration of Composite CR, defined as the time from first documented response of CR, CRi or CRhi to relapse or death from any cause | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | Posted | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months |
| |||||||||||||||||||||||||||||
| Secondary | Transfusion Independence | Rates of 28- and 56-day Transfusion Independence (TI) = Percentages of patients who do not receive red blood cell (RBC) transfusions, platelet (PLT) transfusions, and neither RBC nor PLT transfusions for 28 and 56 days; comprised of 6 secondary endpoints | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | Posted | Transfusion dependence was measured from 28 days prior to first dose through 56 days after last dose, an average of 6 months |
|
Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, up to 14 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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lead-In Cohort: Arm 1 | ALDAC: Alvocidib administered intravenously on days 1 and 15 + cytarabine administered by subcutaneous injection days 3-12 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) | 2 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Lead-In Cohort: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) | 3 | 4 | 3 | 4 | 4 | 4 |
| EG002 | Stage 1: Arm 1 | ALDAC: Alvocidib administered intravenously on days 1 and 15 + cytarabine administered by subcutaneous injection days 3-12 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) | 1 | 2 | 2 | 2 | 2 | 2 |
| EG003 | Stage 1: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) | 1 | 2 | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| disease progression | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia refractory | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| leukocytosis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Diverticultits | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia refractory | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reyna Bishop | Sumitomo Pharma Oncology, Inc | 512-363-8755 | reyna.bishop@oncology.Sumitomo-Pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2021 | Jun 1, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C077990 | alvocidib |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black |
|
| Hispanic |
|
| Asian |
|
| Other |
|
| Not reported |
|
| Stage 1: Arm 2 |
ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
|
| OG003 | Stage 1: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
|
| OG003 |
| Stage 1: Arm 2 |
ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
|
ALDAC: Alvocidib administered intravenously on days 1 and 15 + cytarabine administered by subcutaneous injection days 3-12 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed)
| OG003 | Stage 1: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
|
| OG003 | Stage 1: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
|
| OG003 | Stage 1: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
|
| OG003 | Stage 1: Arm 2 | ALV: Alvocidib administered intravenously on days 1, 8 and 15 of each 28 day cycle. Patients were stratified based on response to prior therapy (i.e. Refractory or Relapsed) |
|