Clinical trials evaluating ibrutinib as a single-agent or in combination for MCL
| Reference . | NCT ID . | Disease status . | Study type . | Treatment . | No. of patients . | Age (y) . | Efficacy . | Adverse event . | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Median . | Range . | |||||||||
| 18 | NCT00849654 | r/r | Multicenter, open-label, phase 1 | Ibrutinib (dose escalation) | 9 | 65* | 41-84 | ORR 77% CR 3/9 PFS NA OS NA | Diarrhea 55.5%* Fatigue 22.2%* Nausea/vomiting 42.9%* Cough 32%* Bleeding NA Infection NA Atrial fibrillation NA | |
| 16, 17 | NCT01236391 | r/r | Multicenter, open-label, phase 2 | Ibrutinib 560 mg | 111 | 68 | 40-84 | ORR 67% CR 23% 2-y PFS 31% 2-y OS 47% | Diarrhea 54% Fatigue 50% Nausea 33% Dyspnea 32% Bleeding 50% Infection 78% Atrial fibrillation 11% | |
| 14 | NCT01646021 | r/r | Multicenter, randomized open-label; phase 3 | Ibrutinib vs temsirolimus | 139† | 67† (≥65 y, 62%) | ORR 72%† CR 19%† 2-y PFS 41%† 1-y OS 68%† | Diarrhea29%† Fatigue 22%† Nausea 14%† Cough 22%† Major bleeding 10%† Infection NA | ||
| 20 | NCT01880567 | r/r | Single-center, open-label, phase 2 | Ibrutinib plus rituximab | 50 | 67 | 45-86 | ORR 88% CR 44% 1-y PFS 75% 1-y OS 85.5% | Diarrhea 82% Fatigue 98% Nausea 54% Dyspnea 52% Bleeding NA Infection NA Atrial fibrillation 14% | |
| 19 | NCT01479842 | First-line and r/r | Single center, open-label, phase 1/1B | Rituximab-bendamustine plus ibrutinib (dose escalation) | 17 | 62* | 23-84 | ORR 94% CR 76% 2-y PFS 50.3%* 2-y OS 56.5%* | Diarrhea NA Grade 3-4 fatigue 2%* Grade 3-4 nausea 4%* Dyspnea NA Bleeding NA Grade 3-4 infection 6%* Rash 25% Atrial fibrillation NA | |
| 21 | NCT01569750 | First-line | Multicenter, open-label, phase 1B | R-CHOP plus ibrutinib (dose escalation) | 5 | 60.5* | 41-84 | ORR 94%* CR 72%* PFS NA OS NA | Diarrhea 39%* Fatigue 45%* Nausea 70%* Dyspnea 27%* Bleeding NA Upper respiratory tract illness 15%* Pneumonia 12%* Febrile neutropenia 18%* Urinary tract infection 9%* Atrial fibrillation NA | |
| Reference . | NCT ID . | Disease status . | Study type . | Treatment . | No. of patients . | Age (y) . | Efficacy . | Adverse event . | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Median . | Range . | |||||||||
| 18 | NCT00849654 | r/r | Multicenter, open-label, phase 1 | Ibrutinib (dose escalation) | 9 | 65* | 41-84 | ORR 77% CR 3/9 PFS NA OS NA | Diarrhea 55.5%* Fatigue 22.2%* Nausea/vomiting 42.9%* Cough 32%* Bleeding NA Infection NA Atrial fibrillation NA | |
| 16, 17 | NCT01236391 | r/r | Multicenter, open-label, phase 2 | Ibrutinib 560 mg | 111 | 68 | 40-84 | ORR 67% CR 23% 2-y PFS 31% 2-y OS 47% | Diarrhea 54% Fatigue 50% Nausea 33% Dyspnea 32% Bleeding 50% Infection 78% Atrial fibrillation 11% | |
| 14 | NCT01646021 | r/r | Multicenter, randomized open-label; phase 3 | Ibrutinib vs temsirolimus | 139† | 67† (≥65 y, 62%) | ORR 72%† CR 19%† 2-y PFS 41%† 1-y OS 68%† | Diarrhea29%† Fatigue 22%† Nausea 14%† Cough 22%† Major bleeding 10%† Infection NA | ||
| 20 | NCT01880567 | r/r | Single-center, open-label, phase 2 | Ibrutinib plus rituximab | 50 | 67 | 45-86 | ORR 88% CR 44% 1-y PFS 75% 1-y OS 85.5% | Diarrhea 82% Fatigue 98% Nausea 54% Dyspnea 52% Bleeding NA Infection NA Atrial fibrillation 14% | |
| 19 | NCT01479842 | First-line and r/r | Single center, open-label, phase 1/1B | Rituximab-bendamustine plus ibrutinib (dose escalation) | 17 | 62* | 23-84 | ORR 94% CR 76% 2-y PFS 50.3%* 2-y OS 56.5%* | Diarrhea NA Grade 3-4 fatigue 2%* Grade 3-4 nausea 4%* Dyspnea NA Bleeding NA Grade 3-4 infection 6%* Rash 25% Atrial fibrillation NA | |
| 21 | NCT01569750 | First-line | Multicenter, open-label, phase 1B | R-CHOP plus ibrutinib (dose escalation) | 5 | 60.5* | 41-84 | ORR 94%* CR 72%* PFS NA OS NA | Diarrhea 39%* Fatigue 45%* Nausea 70%* Dyspnea 27%* Bleeding NA Upper respiratory tract illness 15%* Pneumonia 12%* Febrile neutropenia 18%* Urinary tract infection 9%* Atrial fibrillation NA | |