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| ID | Type | Description | Link |
|---|---|---|---|
| B1931003 | Other Identifier | Alias Study Number | |
| 2009-015497-35 | EudraCT Number |
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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (R-CVP) | Experimental | Subjects in arm 1 will be enrolled in dose escalation cohorts that will initially evaluate an escalating dose of cyclophosphamide in combination with set doses of inotuzumab ozogamicin, vincristine, prednisone, and rituximab. |
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| Arm 2 (R-GDP) | Experimental | Subjects in arm 2 will be enrolled in dose escalation cohorts that will initially evaluate escalating doses of gemcitabine and/or cisplatinum in combination with set doses of inotuzumab ozogamicin, dexamethasone, and rituximab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone | Drug | Day 1: Rituximab at 375 mg/m2 Cyclophosphamide at 375 mg/m2 (cohort 1), 550mg/m2 (cohort 2), 750 mg/m2 (cohort 3, 4) Vincristine at 1.4 mg/m2 (max 2 mg) Day 2 Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2, 3), 1.3 mg/m2 (cohort 4) Days 1-5: Prednisone at 40 mg/m2 Each cycle is 3 weeks, with a maximum of 6 cycles total. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1 | DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. | From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle. |
| Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2 | DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. | From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle. |
| Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts | OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 centimeters [cm] in their greatest transverse diameter (GTD) for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts | OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davis Cancer Pavillion and Shands Medical Plaza | Gainesville | Florida | 32608 | United States | ||
| Shands Cancer Hospital At The University Of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28959500 | Derived | Sangha R, Davies A, Dang NH, Ogura M, MacDonald DA, Ananthakrishnan R, Paccagnella ML, Vandendries E, Boni J, Goh YT. Phase 1 study of inotuzumab ozogamicin combined with R-GDP for the treatment of patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma. J Drug Assess. 2017 Aug 16;6(1):10-17. doi: 10.1080/21556660.2017.1315336. eCollection 2017. | |
| 27154915 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Screening included CD-20 & CD-22 immunophenotyping of NHL, international prognostic index or follicular lymphoma international prognostic index score, B-symptom and lymphoma evaluation, Eastern Cooperative Oncology Group performance status, left ventricular ejection fraction assessment, computed tomography scans, bone marrow aspirate and/or biopsy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | IV inotuzumab ozogamicn (0.8 or 1.3 mg/m^2 on Day 2 of each 21-day cycle) in combination with rituximab (375 mg/m^2) and vincristine (1.4mg/m^2) administererd IV on day 1, prednisone (40mg/m^2) PO on Day 1-5 and cyclophosphamid IV (375, 550 or 750 mg/m^2) on Day 1 of each 21-day cycle (R-CVP) for a maximum of 6 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone | Drug | Day 1: Rituximab at 375 mg/m2 Gemcitabine at 500 mg/m2 (cohort 1, 2b, 3b), 1000mg/m2 (cohort 2a, 3a, 4, 5) Cisplatin at 37.5 mg/m2 (cohort 1, 2a), 50mg/m2 (cohort 2b, 3a), 75mg/m2 (cohort 3b, 4, 5) Day 2: Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2a, 2b, 3a, 3b, 4), 1.3mg/m2 (cohort 5) Days 1-4: Dexamethasone at 40 mg Each cycle is 3 weeks, with a maximum of 6 cycles total. |
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| From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks. |
| Percentage of Participants With a Treatment Emergent AE | An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event may not necessarily have had a causal relationship with the treatment or usage. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as those occurring on or after the first study drug dose day through and including 56 days post last dose of study drug. The severity of all AEs was graded by the investigator using the National Cancer Institute Common Terminology Criteria for AE Version 3.0 (NCI CTCAE v3.0). | SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit. |
| Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy | The following parameters were analyzed for blood chemistry: blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals "severe" and CTCAE Grade 4 equals "life threatening or disabling." | Within 3 days prior to the start of each cycle, on Day 8 of each cycle, on Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days. |
| Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy | The following parameters were analyzed for hematology: lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals "severe" and CTCAE Grade 4 equals "life threatening or disabling." | Within 3 days prior to the start of each cycle, Day 8 of each cycle, Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days. |
| From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks. |
| Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts | PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with overall response of CR, PR, stable disease (SD), or disease progression (PD), but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. | From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks |
| Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts | Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. | 6, 12 and 24 months |
| Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts | PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. | From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks |
| Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts. | Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. | 6, 12, and 24 months |
| Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts | OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. | From first dose of study medication through 2 year follow-up period |
| Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts | OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. | 6, 12, and 24 months |
| Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts | OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. | From first dose of study medication through 2 year follow-up period |
| Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts | OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. | 6, 12, and 24 Months |
| Mean Inotuzumab Ozogamicin Serum Concentrations | Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. | Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8. |
| Gainesville |
| Florida |
| 32608 |
| United States |
| Shands Hospital at the University of Florida | Gainesville | Florida | 32610 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Northwest Medical Specialties, PLLC | Federal Way | Washington | 98003 | United States |
| Northwest Medical Specialties, PLLC | Gig Harbor | Washington | 98332 | United States |
| Northwest Medical Specialties, PLLC | Lakewood | Washington | 98499 | United States |
| Rainier Physicians, PC | Puyallup | Washington | 98373 | United States |
| Northwest Medical Specialties PLLC | Tacoma | Washington | 98405 | United States |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Gasthuisberg | Leuven | 3000 | Belgium |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Queen Elizabeth Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Saint-Louis -Universite Paris VII | Paris | 75010 | France |
| Hospital Saint-Louis - Service d'Hemato-Oncologie | Paris | 75475 | France |
| Centre Hospitalier Lyon Sud - Service d'Hematologie | Pierre-Bénite | 69495 | France |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Nagoya Daini Red Cross Hospital | Nagoya | Aichi-ken | 466-8650 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Cancer Institute Hospital, Japanese Foundation For Cancer Research | Koto-Ku | Tokyo | 135-8550 | Japan |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Nuffield Hospital | Eastleigh | Hants | SO53 2DW | United Kingdom |
| Spire Southampton Hospital | Southampton | Hants | SO16 6UY | United Kingdom |
| Cancer Sciences Division, Somers Cancer Research Building | Southampton | Hants | SO16 6YD | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| Ogura M, Tobinai K, Hatake K, Davies A, Crump M, Ananthakrishnan R, Ishibashi T, Paccagnella ML, Boni J, Vandendries E, MacDonald D. Phase I Study of Inotuzumab Ozogamicin Combined with R-CVP for Relapsed/Refractory CD22+ B-cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2016 Oct 1;22(19):4807-4816. doi: 10.1158/1078-0432.CCR-15-2488. Epub 2016 May 6. |
| FG001 |
| Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin |
IV inotuzumab ozogamicin (0.8 mg/m^2 on Day 2 of each 21-day cycle) in combination with IV Rituximab (375 mg/m^2 on Day 1), dexamethasone (40 mg PO on Days 1 to 4), and escalating doses of IV gemcitabine (500 or 1000 mg/m^2) or IV cisplatinum (0, 37.5, 50 or 75 mg/m^2) on Day 1 of each 21-day cycle (R-GDP) for a maximum of 6 cycles. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | IV inotuzumab ozogamicn (0.8 or 1.3 mg/m^2 on Day 2 of each 21-day cycle) in combination with rituximab (375 mg/m^2) and vincristine (1.4mg/m^2) administererd IV on day 1, prednisone (40mg/m^2) PO on Day 1-5 and cyclophosphamid IV (375, 550 or 750 mg/m^2) on Day 1 of each 21-day cycle (R-CVP) for a maximum of 6 cycles. |
| BG001 | Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | IV inotuzumab ozogamicin (0.8 mg/m^2 on Day 2 of each 21-day cycle) in combination with IV Rituximab (375 mg/m^2 on Day 1), dexamethasone (40 mg PO on Days 1 to 4), and escalating doses of IV gemcitabine (500 or 1000 mg/m^2) or IV cisplatinum (0, 37.5, 50 or 75 mg/m^2) on Day 1 of each 21-day cycle (R-GDP) for a maximum of 6 cycles. |
| BG002 | 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 | Age measure using mean with Standard deviation | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Gender | 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 | Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1 | DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. | Safety Analysis Population includes all subjects who received at least 1 cycle of study drug. Analysis population for DLT is participants evaluable for DLT. | Posted | Count of Participants | Participants | From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle. |
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| Secondary | Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts | OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. | ITT population | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks. |
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| Primary | Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2 | DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. | Safety Analysis Population includes all subjects who received at least 1 cycle of study drug. Analysis population for DLT is participants evaluable for DLT. | Posted | Count of Participants | Participants | From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle. |
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| Primary | Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts | OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 centimeters [cm] in their greatest transverse diameter (GTD) for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. | Intent-to-Treat (ITT) population: all participants enrolled into the study | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks. |
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| Secondary | Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts | PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with overall response of CR, PR, stable disease (SD), or disease progression (PD), but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. | ITT population | Posted | Median | 95% Confidence Interval | Months | From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks |
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| Secondary | Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts | Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. | ITT population | Posted | Number | 95% Confidence Interval | Percent Probability | 6, 12 and 24 months |
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| Secondary | Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts | PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. | ITT population | Posted | Median | 95% Confidence Interval | Months | From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks |
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| Secondary | Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts. | Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. | ITT population | Posted | Number | 95% Confidence Interval | Percent Probability | 6, 12, and 24 months |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts | OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. | ITT population | Posted | Median | 95% Confidence Interval | Months | From first dose of study medication through 2 year follow-up period |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts | OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. | ITT population | Posted | Number | 95% Confidence Interval | Percent Probability | 6, 12, and 24 months |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts | OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. | ITT population | Posted | Median | 95% Confidence Interval | Months | From first dose of study medication through 2 year follow-up period |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts | OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. | ITT population | Posted | Number | 95% Confidence Interval | Percent Probability | 6, 12, and 24 Months |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Treatment Emergent AE | An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event may not necessarily have had a causal relationship with the treatment or usage. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as those occurring on or after the first study drug dose day through and including 56 days post last dose of study drug. The severity of all AEs was graded by the investigator using the National Cancer Institute Common Terminology Criteria for AE Version 3.0 (NCI CTCAE v3.0). | Safety population - included all participants who received ≥1 cycle of investigational product | Posted | Number | Percentage of Participants | SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit. |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy | The following parameters were analyzed for blood chemistry: blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals "severe" and CTCAE Grade 4 equals "life threatening or disabling." | Safety population | Posted | Number | Percentage of Participants | Within 3 days prior to the start of each cycle, on Day 8 of each cycle, on Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days. |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy | The following parameters were analyzed for hematology: lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals "severe" and CTCAE Grade 4 equals "life threatening or disabling." | Safety population | Posted | Number | Percentage of Participants | Within 3 days prior to the start of each cycle, Day 8 of each cycle, Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days. |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Inotuzumab Ozogamicin Serum Concentrations | Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. | PK population - included all participants who provided samples for PK analysis. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8. |
|
SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit.
Presented SAEs & AEs are treatment-emergent events (occurring on or after first study drug dose through and including 56 days post last dose of study drug).
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 | Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | IV inotuzumab ozogamicn (0.8 or 1.3 mg/m^2 on Day 2 of each 21-day cycle) in combination with rituximab (375 mg/m^2) and vincristine (1.4mg/m^2) administererd IV on day 1, prednisone (40mg/m^2) PO on Day 1-5 and cyclophosphamid IV (375, 550 or 750 mg/m^2) on Day 1 of each 21-day cycle (R-CVP) for a maximum of 6 cycles. | 15 | 48 | 48 | 48 | ||
| EG001 | Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | IV inotuzumab ozogamicin (0.8 mg/m^2 on Day 2 of each 21-day cycle) in combination with IV Rituximab (375 mg/m^2 on Day 1), dexamethasone (40 mg PO on Days 1 to 4), and escalating doses of IV gemcitabine (500 or 1000 mg/m^2) or IV cisplatinum (0, 37.5, 50 or 75 mg/m^2) on Day 1 of each 21-day cycle (R-GDP) for a maximum of 6 cycles. | 25 | 55 | 55 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 17.0 | Non-systematic Assessment |
| |
| Transitional cell carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 17.0 | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Device occlusion | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Corynebacterium infection | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDra 17.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDra 17.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDra 17.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Venoocclusive liver disease | Hepatobiliary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDra 17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDra 17.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 17.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDra 17.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| Protein total decreased | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 17.0 | Non-systematic Assessment |
|
This is a preliminary study with a limited number of participants, which was performed primarily to assess safety.The sample size for this study was determined by clinical rather than statistical considerations.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000080045 | Inotuzumab Ozogamicin |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| OG001 | DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | Participants received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with R-GDP. Rituximab (375 mg/m^2) was administered IV on Day 1 and dexamethasone (40 mg) PO on Days 1 to 4. Participants received escalating doses of gemcitabine (500 or 1000 mg/m^2) or cisplatinum (0, 37.5, 50 or 75 mg/m^2) and were administered IV on Day 1 of each 21-day cycle, for a maximum of 6 cycles. DE in Arm 2 was conducted using an up-and-down dose escalation method by increasing or decreasing the dose of either cisplatinum or gemcitabine to determine the MTD. |
|
|
| OG002 | Cohort 2b, Arm 2 | Participants in cohort 2b of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (500 mg/m^2) and cisplatinum (50 mg/m^2) administered IV on Day 1 of each 21-day cycle. |
| OG003 | Cohort 3b, Arm 2 | Participants in cohort 3b of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (500 mg/m^2) and cisplatinum (75 mg/m^2) administered IV on Day 1 of each 21-day cycle. |
| OG004 | Cohort 4, Arm 2 | Participants in cohort 4 of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (1000 mg/m^2) administered IV on Day 1 of each 21-day cycle. |
| OG005 | MTD Confirmation Cohort, Arm 2 | Participants in the MTD cohort of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2), cisplatinum (50 mg/m^2) and gemcitabine (500 mg/m^2) IV on Day 1, and dexamethasone (40 mg) PO on Days 1 to 4 of each 21-day cycle. |
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| OG001 | MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | Participants received rituximab (375 mg/m^2), cisplatinum (50 mg/m^2) and gemcitabine (500 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles. |
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Participants received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with R-GDP. Rituximab (375 mg/m^2) was administered IV on Day 1 and dexamethasone (40 mg) PO on Days 1 to 4. Participants received escalating doses of gemcitabine (500 or 1000 mg/m^2) or cisplatinum (0, 37.5, 50 or 75 mg/m^2) and were administered IV on Day 1 of each 21-day cycle, for a maximum of 6 cycles. DE in Arm 2 was conducted using an up-and-down dose escalation method by increasing or decreasing the dose of either cisplatinum or gemcitabine to determine the MTD. |
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| OG001 | DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | Participants received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with R-GDP. Rituximab (375 mg/m^2) was administered IV on Day 1 and dexamethasone (40 mg) PO on Days 1 to 4. Participants received escalating doses of gemcitabine (500 or 1000 mg/m^2) or cisplatinum (0, 37.5, 50 or 75 mg/m^2) and were administered IV on Day 1 of each 21-day cycle, for a maximum of 6 cycles. DE in Arm 2 was conducted using an up-and-down dose escalation method by increasing or decreasing the dose of either cisplatinum or gemcitabine to determine the MTD. |
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| MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin |
Participants received rituximab (375 mg/m^2), cisplatinum (50 mg/m^2) and gemcitabine (500 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles. |
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| OG001 | Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | IV inotuzumab ozogamicin (0.8 mg/m^2 on Day 2 of each 21-day cycle) in combination with IV Rituximab (375 mg/m^2 on Day 1), dexamethasone (40 mg PO on Days 1 to 4), and escalating doses of IV gemcitabine (500 or 1000 mg/m^2) or IV cisplatinum (0, 37.5, 50 or 75 mg/m^2) on Day 1 of each 21-day cycle (R-GDP) for a maximum of 6 cycles. |
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| OG002 |
| Cohort 3b, Arm 2 |
Participants in cohort 3b of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (500 mg/m^2) and cisplatinum (75 mg/m^2) administered IV on Day 1 of each 21-day cycle. |
| OG003 | Cohort 4, Arm 2 | Participants in cohort 4 of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (1000 mg/m^2) administered IV on Day 1 of each 21-day cycle. |
| OG004 | Cohort 3/MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | Participants received rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) IV on Day 1, inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2, prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV at 750 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 6 cycles. |
| OG005 | Cohort 2b/MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | Participants received rituximab (375 mg/m^2), cisplatinum (50 mg/m^2) and gemcitabine (500 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles. |
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