Ongoing clinical trials with obinutuzumab
| ClinicalTrials.gov identifier . | Title . | Phase . | Obinutuzumab . | Combination drug . | Primary end point . |
|---|---|---|---|---|---|
| NCT02292225 | Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY) | 1B | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15, C2-6: 1000 mg D1 | Duvelisib (IPI-145) dose escalation | Safety, tolerability, and DLT |
| NCT02537613 | A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia | 1B | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1; arm B: same as above, but start at C2 | Ibrutinib 420 mg daily starting at C2 (arm A), or ibrutinib 420 mg daily starting at C1 (arms B and C) | Safety, tolerability, and DLT |
| NCT02315768 | Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients | 1B/2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | Ibrutinib 420 mg by mouth daily for up to 6 cycles | Phase 1B: safety, tolerability, and DLT, phase 2: ORR |
| NCT02427451 | Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or Previously Untreated Chronic Lymphocytic Leukemia | 1B/2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | Starting at C2: ibrutinib 420 mg daily; starting at C3: GDC-0199 by mouth daily for up to 14 courses | Phase 1B: safety, tolerability, and DLT; phase 2: ORR, MRD negative CR rate |
| NCT02345863 | Sequential Regimen of Bendamustin [B] Followed by GA101 and Ibrutinib [I] in CLL Patients | 2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1; maintenance dose every 3 months | Bendamustine 70 mg/m2 for 2 cycles; C2-6: ibrutinib 420 mg daily | ORR |
| NCT02320383 | CLLR3: FC + GA101 and B + GA101 in Relapsed or Refractory CLL Followed by GA101 Maintenance for Responding Patients | 2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1; maintenance dose every 3 months | C1: fludarabine 25 mg/m2 D3-5 and D2-4 in C2-6; C1: cyclophosphamide 250 mg/m2 D3-5 and D2-4 in C2-6 | ORR |
| NCT02071225 | A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia | 2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | C1: bendamustine 70 mg/m2 D2-3; C2-6: 70 mg/m2 D1-2 | ORR |
| NCT01980875 | Idelalisib + obinutuzumab vs chlorambucil + obinutuzumab in untreated CLL | 3 | 1000 mg IV for a total of 8 doses over 21 weeks | Idelalisib 150 mg by mouth twice daily; chlorambucil 2 mg every other week for a total of 12 doses | PFS |
| NCT02475681 | Study of Obinutuzumab + Chlorambucil, ACP-196 + Obinutuzumab, and ACP-196 in Subjects With Previously Untreated CLL | 3 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | C1-6: chlorambucil D1 and D15; starting on C1: ACP-196 D1 until progression or toxicity | PFS |
| NCT02242942 | A Study to Compare the Efficacy and Safety of Obinutuzumab + GDC-0199 Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia | 3 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | C1-12: chlorambucil 0.5 mg/kg D1 and D15; C1-2: GDC-0199 dose-increase from 20 to 400 mg daily; C3-12: 400 mg daily | PFS |
| ClinicalTrials.gov identifier . | Title . | Phase . | Obinutuzumab . | Combination drug . | Primary end point . |
|---|---|---|---|---|---|
| NCT02292225 | Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY) | 1B | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15, C2-6: 1000 mg D1 | Duvelisib (IPI-145) dose escalation | Safety, tolerability, and DLT |
| NCT02537613 | A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia | 1B | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1; arm B: same as above, but start at C2 | Ibrutinib 420 mg daily starting at C2 (arm A), or ibrutinib 420 mg daily starting at C1 (arms B and C) | Safety, tolerability, and DLT |
| NCT02315768 | Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients | 1B/2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | Ibrutinib 420 mg by mouth daily for up to 6 cycles | Phase 1B: safety, tolerability, and DLT, phase 2: ORR |
| NCT02427451 | Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or Previously Untreated Chronic Lymphocytic Leukemia | 1B/2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | Starting at C2: ibrutinib 420 mg daily; starting at C3: GDC-0199 by mouth daily for up to 14 courses | Phase 1B: safety, tolerability, and DLT; phase 2: ORR, MRD negative CR rate |
| NCT02345863 | Sequential Regimen of Bendamustin [B] Followed by GA101 and Ibrutinib [I] in CLL Patients | 2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1; maintenance dose every 3 months | Bendamustine 70 mg/m2 for 2 cycles; C2-6: ibrutinib 420 mg daily | ORR |
| NCT02320383 | CLLR3: FC + GA101 and B + GA101 in Relapsed or Refractory CLL Followed by GA101 Maintenance for Responding Patients | 2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1; maintenance dose every 3 months | C1: fludarabine 25 mg/m2 D3-5 and D2-4 in C2-6; C1: cyclophosphamide 250 mg/m2 D3-5 and D2-4 in C2-6 | ORR |
| NCT02071225 | A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia | 2 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | C1: bendamustine 70 mg/m2 D2-3; C2-6: 70 mg/m2 D1-2 | ORR |
| NCT01980875 | Idelalisib + obinutuzumab vs chlorambucil + obinutuzumab in untreated CLL | 3 | 1000 mg IV for a total of 8 doses over 21 weeks | Idelalisib 150 mg by mouth twice daily; chlorambucil 2 mg every other week for a total of 12 doses | PFS |
| NCT02475681 | Study of Obinutuzumab + Chlorambucil, ACP-196 + Obinutuzumab, and ACP-196 in Subjects With Previously Untreated CLL | 3 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | C1-6: chlorambucil D1 and D15; starting on C1: ACP-196 D1 until progression or toxicity | PFS |
| NCT02242942 | A Study to Compare the Efficacy and Safety of Obinutuzumab + GDC-0199 Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia | 3 | C1: 100 mg D1, 900 mg D2, 1000 mg D8 and D15; C2-6: 1000 mg D1 | C1-12: chlorambucil 0.5 mg/kg D1 and D15; C1-2: GDC-0199 dose-increase from 20 to 400 mg daily; C3-12: 400 mg daily | PFS |
C, cycle; CR, complete response; D, day; DLT, dose-limiting toxicity; IV, intravenous; MRD, minimal residual disease; ORR, overall response rate.