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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002480-34 | EudraCT Number |
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Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.
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This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with idasanutlin and venetoclax in participants with R/R FL and obinutuzumab or rituximab in combination with idasanutlin and venetoclax in participants with R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase II doses (RP2Ds) and regimen for idasanutlin and venetoclax in combination with obinutuzumab for FL participants and in combination with rituximab for DLBCL participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-Escalation Cohort: FL | Experimental | Induction Treatment: Participants will receive either Regimen A or Regimen B. Regimen A: Participants will receive either obinutuzumab on Days 1, 8, 15 of Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin and venetoclax on Days 1 to 5 of Cycles 1 to 6 or obinutuzumab on Days 1, 8, 15 on Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin on Days 1 to 5 and venetoclax on Days 1 to 10 of Cycles 1 to 6. Regimen B (in bridging cohort): Participants will receive obinutuzumab alone in Cycle 1 and obinutuzumab with idasanutlin and venetoclax (both at maximum tolerated dose [MTD] established from Regimen A) in Cycles 2 to 6. Post-Induction Treatment (Maintenance Treatment): Participants will receive obinutuzumab every 2 months for 24 months; idasanutlin and venetoclax for 6 months. |
|
| Dose-Escalation Cohort: DLBCL | Experimental | Induction Treatment: Participants will receive either obinutuzumab on Days 1, 8, 15 of Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin and venetoclax on Days 1 to 5 of Cycles 1 to 6 or obinutuzumab on Days 1, 8, 15 on Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin on Days 1 to 5 and venetoclax on Days 1 to 10 of Cycles 1 to 6. In bridging cohort, participants will receive rituximab on Day 1 of Cycles 1 to 6 and idasanutlin and venetoclax (both at MTD) in Cycles 1 to 6. Post-Induction Treatment (Consolidation Treatment): Participants will receive obinutuzumab or rituximab (according to study treatment received in the induction) every 2 months for 6 months; idasanutlin and venetoclax for 6 months. |
|
| Expansion Cohort: FL | Experimental | Induction Treatment: Participants will receive idasanutlin and venetoclax at the RP2D of the selected regimen (Regimen A or B) identified during the dose-escalation phase in combination with obinutuzumab. Regimen A: Participants will receive either obinutuzumab on Days 1, 8, 15 of Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin and venetoclax on Days 1 to 5 of Cycles 1 to 6 or obinutuzumab on Days 1, 8, 15 on Cycle 1 and then on Day 1 of Cycles 2 to 6; idasanutlin on Days 1 to 5 and venetoclax on Days 1 to 10 of Cycles 1 to 6. Regimen B (in bridging cohort): Participants will receive obinutuzumab alone in Cycle 1 and obinutuzumab with idasanutlin and venetoclax in Cycles 2 to 6. Post-Induction Treatment (Maintenance Treatment): Participants will receive obinutuzumab every 2 months for 24 months; idasanutlin and venetoclax for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idasanutlin | Drug | Induction Treatment: Idasanutlin tablets will be administered orally once daily at escalated doses (starting dose 100 milligrams [mg], maximum 600 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction. |
| Measure | Description | Time Frame |
|---|---|---|
| RP2D of Idasanutlin When Given in Combination With Obinutuzumab or Rituximab | It was planned to be identified in escalation and carried over in expansion phases. However the expansion phase did not take place. phases. The study was closed because at escalation doses 100 (in combination with venetoclax 400 mg) and 150 mg (in combination with venetoclax 200 mg) Idasanutlin, the benefit was mild. The study was terminated at the escalation phase with DLTs showing AEs in all cohorts. The subpopulations of DLBCL and FL were showed no difference in their genetic subtype make-up, therefore, Cohorts Safety, 1, 2, 3 contain both populations. The safety cohort had a different venetoclax schedule of 5 days to ensure safety. Remaining cohorts used a 10 days schedule. No RP2D was identified in the Cohorts 1 and 3. | Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days) |
| RP2D of Venetoclax When Given in Combination With Obinutuzumab or Rituximab | It was planned to be identified in escalation and carried over in expansion phases. However the expansion phase did not take place. The study was closed because at escalation doses 200 (in combination with 150 mg idasanutlin) and 400 (in combination with 100 mg idasanutlin) mg Venetoclax, the benefit was mild. The study was terminated at the escalation phase with DLTs showing AEs in all cohorts. The safety cohort had a different venetoclax schedule of 5 days to ensure safety. Remaining cohorts used a 10 days schedule. No RP2D was identified in the Cohorts 1 and 3. | Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days) |
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | DLT is defined as any one of the following events occurring during first two Cycles of treatment and assessed by the investigator as clearly not related to patient's underlying disease: - Any Grade 5 adverse event (AE) unless unequivocally due to the underlying malignancy or extraneous causes; - AE of any grade that leads to a delay of more than 14 days at the start of next treatment cycle; - Hematologic AEs (neutropenia, thrombocytopenia); - Non-hematologic AE, except IRRs, laboratory TLS without manifestations of clinical TLS, AST or ALT, diarrhea, nausea or vomiting, fatigue, asthenia, anorexia, or constipation, hepatic transaminase. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CR, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT based complete response (CR), which required a complete metabolic response with a score of 1, 2 or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to [<=] mediastinum; 3 = uptake greater than [>] mediastinum and <= liver; 4 = uptake moderately > liver; 5 = uptake markedly > liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if intermediate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045-2517 | United States | ||
| The University of Chicago Medical Center |
The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase.
In each DLBCL and FL arm, participants are in Safety Cohort, Cohort 1, Cohort 2, Cohort 3 and Cohort 3- Not defined (DLBCL only).
All Adverse Events are reported per Cohort rather than per Arm.
29 Participants (ITT population) were enrolled at 13 sites in the USA, Australia, South Korea, New Zealand and Germany during the dose escalation phase. 1 participant was undefined as the diagnosis at study entry was not provided.
Due to the study's pre-mature termination, the planned Dose Expansion Phase did not take place for both arms DLBCL and FL.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation DLBCL and FL Safety Cohort | Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg |
| FG001 | Dose Escalation DLBCL and FL Cohort 1 | Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg |
| 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 | Jun 13, 2018 | Apr 26, 2021 |
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| Expansion Cohort: DLBCL | Experimental | Induction Treatment: Participants will receive rituximab on Day 1 of Cycles 1 to 6; idasanutlin and venetoclax (both at RP2D) on Days 1 to 5 of Cycles 1 to 6 or rituximab on Day 1 of Cycles 1 to 6; idasanutlin on Days 1 to 5 and venetoclax on Days 1 to 10 of Cycles 1 to 6. Post-Induction Treatment (Consolidation Treatment): Participants will receive rituximab every 2 months for 6 months; idasanutlin and venetoclax for 6 months. |
|
|
| Obinutuzumab | Drug | Participants will receive a fixed dose of obinutuzumab, 1000 mg by intravenous (IV) infusion on Days 1, 8 and 15 of Cycle 1 and on Day 1 of each subsequent cycle (Cycles 2 to 6) (each cycle = 28 days) during induction treatment, and on Day 1 of every other month during maintenance treatment (eligible participants with FL only) or during consolidation treatment (eligible participants with DLBCL only). |
|
| Venetoclax | Drug | Induction Treatment: Venetoclax tablets will be administered orally once daily at escalated doses (starting dose 200 mg, maximum 800 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction. |
|
| Rituximab | Drug | Rituximab will be administered by IV infusion at a dose of 375 milligrams per square meter (mg/m^2) on Day 1 of Cycles 1-6 during induction treatment and on Day 1 of every other month during consolidation treatment. |
|
| Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days) |
| Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a casual relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | From Baseline up to approximately 48 months |
| Percentage of Participants With Complete Response (CR), Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography-Computed Tomography (PET-CT) Scans Using Modified Lugano 2014 Criteria | The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). Therefore the result data not derived and not reported. | At end of Induction (EOI) (within 6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]) |
| At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
| Percentage of Participants With CR, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required to complete radiologic response with all of the following: target nodal masses must regress to less than or equal to 1.5 centimeters in the longest transverse diameter of a lesion [LDi]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. Therefore the result data not derived and not reported. | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
| Percentage of Participants With CR, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The investigator evaluated responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimeters in the longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who received at least 2 cycles of Induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. This outcome measure therefore not derived and not reported. | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
| Percentage of Participants With Objective Response, Determined by the IRC on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | The IRC was to evaluate responses at the end of induction treatment using Luagno 2014 criteria for malignant lymphoma for a PET-CT based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2 or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 [no uptake above background] to 5 [uptake markedly higher than liver and/or new lesions]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Therefore the result data not derived and not reported. The study was pre-maturely terminated. | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
| Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | The investigator was to evaluate responses at end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 [no uptake above background] to 5 [uptake markedly higher than liver and/or new lesions]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders. | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
| Percentage of Participants With Objective Response, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a >=50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/nomal, regressed, but no increase; and spleen must have regressed by >50% in length. Therefore the result data not derived and not reported. The study was pre-maturely terminated. | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
| Percentage of Participants With Objective Response at EOI, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a >=50% decrease in sum of the product of perpendicular diameters up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by >50% in length. The study was pre-maturely terminated at escalation phase. | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
| Percentage of Participants With Objective Response During the Study, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a >=50% decrease in sum of the product of perpendicular diameters up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by >50% in length. The study was pre-maturely terminated at escalation phase. | From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months |
| Observed Serum Concentration of Obinutuzumab in Participants With FL | Observed Serum Concentration of Obinutuzumab in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. | From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description) |
| Observed Serum Concentration of Obinutuzumab in Participants With DLBCL | Observed Serum Concentration of Obinutuzumab in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. | Induction: Pre-dose (any time prior to dose on same day) and 30 min post-dose on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) and 30 min post-dose on Day 1 of Cycles 2, 4 and 6 (each cycle = 28 days) |
| Observed Serum Concentration of Rituximab in Participants With FL | Observed Serum Concentration of Rituximab in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. | Induction: Pre-dose (any time prior to dose on same day) on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) on Day 1 of Cycles 2, 4, 6; 30 min post-dose on Day 1 of Cycles 1 and 6 (each cycle = 28 days) |
| Observed Serum Concentration of Rituximab in Participants With DLBCL | Observed Serum Concentration of Rituximab in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. | From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description) |
| Observed Plasma Concentration of Idasanutlin in Participants With FL | Observed Plasma Concentration of Idasanutlin in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived therefore no result was reported | From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) |
| Observed Plasma Concentration of Idasanutlin in Participants With DLBCL | Observed Plasma Concentration of Idasanutlin in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived therefore no result was reported | From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) |
| Observed Plasma Concentration of Venetoclax in Participants With FL | Observed Plasma Concentration of Venetoclax in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. | From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) |
| Observed Plasma Concentration of Venetoclax in Participants With DLBCL | Observed Plasma Concentration of Venetoclax in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. | From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Norton Cancer Institute - Dutchmans | Louisville | Kentucky | 40207 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Guthrie Clinic | Sayre | Pennsylvania | 18840 | United States |
| Swedish Cancer Inst. | Seattle | Washington | 98104 | United States |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Linear Clinical Research Limited | Nedlands | Western Australia | 6009 | Australia |
| Klinikum Augsburg | Augsburg | 86156 | Germany |
| Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | 01307 | Germany |
| SLK-Kliniken Heilbronn GmbH | Heilbronn | 74078 | Germany |
| Klinikum rechts der Isar der TU München | München | 81675 | Germany |
| Universitätsklinikum Würzburg; Studienzentrale Hämatologie/Onkologie | Würzburg | 97080 | Germany |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Auckland Clinical Studies Limited | Grafton | 1010 | New Zealand |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| FG002 | Dose Escalation DLBCL and FL Cohort 2 | Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg |
| FG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg |
| FG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose-Escalation DLBCL and FL Safety Cohort | Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| BG001 | Dose-Escalation DLBCL and FL Cohort 1 | Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| BG002 | Dose Escaltion DLBCL and FL Cohort 2 | Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| BG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| BG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
| BG005 | 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, Continuous | ITT | Mean | Standard Deviation | Years |
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| Sex: Female, Male | ITT Population | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | ||||||||||||||||||||||||||||||||
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| Primary | RP2D of Idasanutlin When Given in Combination With Obinutuzumab or Rituximab | It was planned to be identified in escalation and carried over in expansion phases. However the expansion phase did not take place. phases. The study was closed because at escalation doses 100 (in combination with venetoclax 400 mg) and 150 mg (in combination with venetoclax 200 mg) Idasanutlin, the benefit was mild. The study was terminated at the escalation phase with DLTs showing AEs in all cohorts. The subpopulations of DLBCL and FL were showed no difference in their genetic subtype make-up, therefore, Cohorts Safety, 1, 2, 3 contain both populations. The safety cohort had a different venetoclax schedule of 5 days to ensure safety. Remaining cohorts used a 10 days schedule. No RP2D was identified in the Cohorts 1 and 3. | Safety Population | Posted | Number | mg | Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days) |
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| Primary | RP2D of Venetoclax When Given in Combination With Obinutuzumab or Rituximab | It was planned to be identified in escalation and carried over in expansion phases. However the expansion phase did not take place. The study was closed because at escalation doses 200 (in combination with 150 mg idasanutlin) and 400 (in combination with 100 mg idasanutlin) mg Venetoclax, the benefit was mild. The study was terminated at the escalation phase with DLTs showing AEs in all cohorts. The safety cohort had a different venetoclax schedule of 5 days to ensure safety. Remaining cohorts used a 10 days schedule. No RP2D was identified in the Cohorts 1 and 3. | Safety Population | Posted | Number | mg | Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days) |
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| Primary | Percentage of Participants With Dose-Limiting Toxicities (DLTs) | DLT is defined as any one of the following events occurring during first two Cycles of treatment and assessed by the investigator as clearly not related to patient's underlying disease: - Any Grade 5 adverse event (AE) unless unequivocally due to the underlying malignancy or extraneous causes; - AE of any grade that leads to a delay of more than 14 days at the start of next treatment cycle; - Hematologic AEs (neutropenia, thrombocytopenia); - Non-hematologic AE, except IRRs, laboratory TLS without manifestations of clinical TLS, AST or ALT, diarrhea, nausea or vomiting, fatigue, asthenia, anorexia, or constipation, hepatic transaminase. | Safety-Evaluable Patients | Posted | Number | Percentage of Participants | Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days) |
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| Primary | Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a casual relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Safety Population | Posted | Number | Percentage of Participants | From Baseline up to approximately 48 months |
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| Primary | Percentage of Participants With Complete Response (CR), Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography-Computed Tomography (PET-CT) Scans Using Modified Lugano 2014 Criteria | The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). Therefore the result data not derived and not reported. | The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). | Posted | At end of Induction (EOI) (within 6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]) |
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| Secondary | Percentage of Participants With CR, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT based complete response (CR), which required a complete metabolic response with a score of 1, 2 or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to [<=] mediastinum; 3 = uptake greater than [>] mediastinum and <= liver; 4 = uptake moderately > liver; 5 = uptake markedly > liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if intermediate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders. | ITT Population; exploratory analysis of the dose escalation phase (Part I). The study plan was for efficacy analyses to be based on responses in participants enrolled during the expansion phase (Part II), but it was not opened (i.e., no enrollment) and at the study was terminated early. | Posted | Number | 90% Confidence Interval | Percentage of Participants | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
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| Secondary | Percentage of Participants With CR, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required to complete radiologic response with all of the following: target nodal masses must regress to less than or equal to 1.5 centimeters in the longest transverse diameter of a lesion [LDi]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. Therefore the result data not derived and not reported. | The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II), but the expansion phase was not opened (i.e. , no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). | Posted | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
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| Secondary | Percentage of Participants With CR, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The investigator evaluated responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimeters in the longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who received at least 2 cycles of Induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. This outcome measure therefore not derived and not reported. | ITT Population; exploratory analysis of the dose escalation phase (Part I). The study plan was for efficacy analyses to be based on responses in participants enrolled during expansion phase (Part II), but it was not opened (i.e., no enrollment) and at the study was terminated early. | Posted | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
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| Secondary | Percentage of Participants With Objective Response, Determined by the IRC on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | The IRC was to evaluate responses at the end of induction treatment using Luagno 2014 criteria for malignant lymphoma for a PET-CT based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2 or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 [no uptake above background] to 5 [uptake markedly higher than liver and/or new lesions]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Therefore the result data not derived and not reported. The study was pre-maturely terminated. | The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II)., but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). | Posted | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
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| Secondary | Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | The investigator was to evaluate responses at end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 [no uptake above background] to 5 [uptake markedly higher than liver and/or new lesions]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders. | ITT Population | Posted | Number | 90% Confidence Interval | Percentage of Participants | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
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| Secondary | Percentage of Participants With Objective Response, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a >=50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/nomal, regressed, but no increase; and spleen must have regressed by >50% in length. Therefore the result data not derived and not reported. The study was pre-maturely terminated. | The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II)., but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). | Posted | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
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| Secondary | Percentage of Participants With Objective Response at EOI, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a >=50% decrease in sum of the product of perpendicular diameters up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by >50% in length. The study was pre-maturely terminated at escalation phase. | The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II)., but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). | Posted | At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days] |
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| Secondary | Percentage of Participants With Objective Response During the Study, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria | The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a >=50% decrease in sum of the product of perpendicular diameters up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by >50% in length. The study was pre-maturely terminated at escalation phase. | The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II)., but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). | Posted | From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months |
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| Secondary | Observed Serum Concentration of Obinutuzumab in Participants With FL | Observed Serum Concentration of Obinutuzumab in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. | ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected. | Posted | From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description) |
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| Secondary | Observed Serum Concentration of Obinutuzumab in Participants With DLBCL | Observed Serum Concentration of Obinutuzumab in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. | ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected. | Posted | Induction: Pre-dose (any time prior to dose on same day) and 30 min post-dose on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) and 30 min post-dose on Day 1 of Cycles 2, 4 and 6 (each cycle = 28 days) |
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| Secondary | Observed Serum Concentration of Rituximab in Participants With FL | Observed Serum Concentration of Rituximab in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. | ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected. | Posted | Induction: Pre-dose (any time prior to dose on same day) on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) on Day 1 of Cycles 2, 4, 6; 30 min post-dose on Day 1 of Cycles 1 and 6 (each cycle = 28 days) |
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| Secondary | Observed Serum Concentration of Rituximab in Participants With DLBCL | Observed Serum Concentration of Rituximab in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. | ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected. | Posted | From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description) |
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| Secondary | Observed Plasma Concentration of Idasanutlin in Participants With FL | Observed Plasma Concentration of Idasanutlin in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived therefore no result was reported | ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected. | Posted | From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) |
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| Secondary | Observed Plasma Concentration of Idasanutlin in Participants With DLBCL | Observed Plasma Concentration of Idasanutlin in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived therefore no result was reported | ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected. | Posted | From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) |
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| Secondary | Observed Plasma Concentration of Venetoclax in Participants With FL | Observed Plasma Concentration of Venetoclax in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. | ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected. | Posted | From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) |
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| Secondary | Observed Plasma Concentration of Venetoclax in Participants With DLBCL | Observed Plasma Concentration of Venetoclax in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. | ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected. | Posted | From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description) |
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From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
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 | Dose Escalation DLBCL and FL Safety Cohort | Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg | 6 | 9 | 3 | 9 | 9 | 9 |
| EG001 | Dose Escalation DLBCL and FL Cohort 1 | Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg | 2 | 6 | 3 | 6 | 6 | 6 |
| EG002 | Dose Escalation DLBCL and FL Cohort 2 | Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg | 2 | 7 | 4 | 7 | 7 | 7 |
| EG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg | 2 | 6 | 4 | 6 | 6 | 6 |
| EG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg | 0 | 1 | 0 | 1 | 0 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| EYE DISORDER | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| EYE PAIN | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| PHOTOPHOBIA | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ANAL INCONTINENCE | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ODYNOPHAGIA | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| TONGUE HAEMATOMA | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| CHILLS | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| PAIN | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| UNEVALUABLE EVENT | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| GASTROENTERITIS NOROVIRUS | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| MUCOSAL INFECTION | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| MEDICATION ERROR | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| PRODUCT ADMINISTRATION ERROR | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| PRODUCT DOSE OMISSION | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| WRONG TECHNIQUE IN PRODUCT USAGE PROCESS | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| AMYLASE INCREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| RESPIROVIRUS TEST POSITIVE | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| SERUM FERRITIN INCREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPOPHAGIA | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| JOINT STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| VERTEBRAL FORAMINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| RADICULAR PAIN | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| LOWER RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ERYTHEMA AB IGNE | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| LYMPHATIC FISTULA | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| THROMBOPHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
|
Dose expansion part of the study did not take place. AEs were not differentiated for DLBCL and FL arms since these are sub mutations of disease which does nor show differences in AEs.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BH39147 | www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2019 | Apr 26, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
| D016393 | Lymphoma, B-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C586849 | RG7388 |
| C543332 | obinutuzumab |
| C579720 | venetoclax |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| 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 |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Dose Escalation DLBCL and FL Cohort 3 |
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
|
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
|
| Dose Escalation DLBCL and FL Cohort 3 |
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
|
| Dose Escaltion DLBCL and FL Cohort 2 |
Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
| OG001 | Dose Escalation DLBCL and FL Cohort 1 | Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG002 | Dose Escalation DLBCL and FL Cohort 2 | Idasanutlin 150 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
|
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG002 | Dose Escaltion DLBCL and FL Cohort 2 | Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG002 | Dose Escalation DLBCL and FL Cohort 2 | Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
| OG001 | Dose Escalation DLBCL and FL Cohort 1 | Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG002 | Dose Escaltion DLBCL and FL Cohort 2 | Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
| OG002 | Dose Escalation DLBCL and FL Cohort 2 | Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
|
| OG001 | Dose Escalation DLBCL and FL Cohort 1 | Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG002 | Dose Escalation DLBCL and FL Cohort 2 | Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
| OG001 | Dose Escalation DLBCL and FL Cohort 1 | Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG002 | Dose Escalation DLBCL and FL Cohort 2 | Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
| OG001 | Dose Escalation DLBCL and FL Cohort 1 | Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG002 | Dose Escalation DLBCL and FL Cohort 2 | Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg |
| OG003 | Dose Escalation DLBCL and FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
| OG003 | Dose Escalation FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
|
| OG003 | Dose Escalation DLBCL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
| OG003 | Dose Escalation FL Cohort 3 | Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
|
| OG003 |
| Dose Escalation DLBCL Cohort 3 |
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
| OG003 |
| Dose Escalation FL Cohort 3 |
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
|
| OG003 |
| Dose Escalation DLBCL Cohort 3 |
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|
| Dose Escalation FL Cohort 3 |
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
|
| Dose Escalation DLBCL Cohort 3 |
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg |
| OG004 | Not Defined for DLBCL or FL Subgroups Cohort 3 | Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg |
|