Epigenetic therapy plus chemotherapy
| Drug . | Disease type . | NCT no. . | Enrollment status . | Response . | Grade 3/4 toxicities . |
|---|---|---|---|---|---|
| Vorinostat + R-DA-EPOCH vs R-DA-EPOCH | AIDS-related DLBCL | NCT01193842 | Active, not recruiting; phase 1/2, N = 90 | CR, 65% vs 77%; 1-y EFS, 75% vs 82% favoring R-EPOCH | Neutropenia, 44% vs 16%;thrombocytopenia, 27% vs 2% |
| Oral azacitidine + R-CHOP | DLBCL/FL/tFL | NCT02343536 | Active, not recruiting; phase 1, N = 59 | ORR, 95%; CR, 88%; 1-y PFS, 86%; 2-y PFS, 80%; | Neutropenia, 52%; febrile neutropenia, 25%; anemia, 17% |
| Vorinostat + R-CHOP | DLBCL | NCT00972478 | Active, not recruiting; phase 1/2, N = 72 | 2-y PFS, 72%; OS, 86% | Febrile neutropenia, 38%; sepsis, 19%; neutropenia, 60%; anemia, 35%; thrombocytopenia, 35% |
| Vorinostat + R-CEP | DLBCL in elderly | NCT00667615 | Completed; phase 1/2, N = 30 | CR, 35%; median PFS, 9.2 mo | Neutropenia, 15%; thrombocytopenia, 12%; hyperglycemia, 11% |
| Azacitidine + R-CHOP | DLBCL | NCT01004991 | Completed; phase 1/2, N = 12 | CR, 92% | Neutropenia, 100%; febrile neutropenia, 25% |
| Tazemetostat + R-CHOP | DLBCL | NCT02889523 | Completed; phase 1b, N = 17 | Metabolic CR, 77% | Neutropenia, 47%; leukopenia, 29%; constipation, 24% |
| Decitabine + COP | DLBCL | NCT03494296 | Recruiting | ||
| Decitabine + R-DHAP | DLBCL | NCT03579082 | Recruiting | ||
| Oral azacitidine + R-ICE | DLBCL | NCT03450343 | Recruiting | ||
| Oral azacitidine + CHOP | PTCL | NCT03542266 | Active, not recruiting | ||
| Romidepsin + CHOP | PTCL | NCT01796002 | Active, not recruiting; phase 1/2, N = 37 | CR, 51%; ORR, 68%; 18-mo PFS, 77% | Neutropenia, 89%; thrombocytopenia, 78%; febrile neutropenia, 14%; pneumonia, 11% |
| Romidepsin + gemcitabine | PTCL | NCT01822886 | Completed; phase 2, N = 20 | CR, 15%; ORR, 30%; 2-y OS, 50% | Thrombocytopenia, 60%; neutropenia, 50%; anemia, 20% |
| Chidamide + CHOP | PTCL | NCT02809573 | Completed; phase 1, N = 30 | CR, 35%; 1-y PFS, 54%; 1-y OS, 100% | Leukopenia, 90%; neutropenia, 83%; lymphocytopenia, 40% |
| Romidepsin + GDP | PTCL | NCT01846390 | Completed; phase 1, N = 20 | ORR, 50%; median PFS, 2.3 mo; median OS, 7.16 mo | Thrombocytopenia, 55%; neutropenia, 30%; anemia, 30% |
| Romidepsin + ICE | PTCL | NCT01590732 | Completed; phase 1, N = 18 | CR, 13%; ORR, 93%; median PFS, 10 mo | Thrombocytopenia, 83%; anemia, 50%; neutropenia, 44% |
| Belinostat + CHOP | PTCL | NCT01839097 | Completed; phase 1, N = 21 | CR, 72%; ORR, 89% | Neutropenia, 26%; anemia, 22% |
| Vorinostat + CHOP | PTCL | NCT00787527 | Completed; phase 1, N = 14 | CR, 93%; 2-y PFS, 79% | Neutropenia, 76% |
| Romidepsin + CHOEP | PTCL | NCT02223208 | Recruiting | ||
| Decitabine + CHOP | PTCL | NCT035537 | Not yet recruiting | ||
| Panobinostat + ICE | HL | NCT0116936 | Completed; phase 1, N = 29; phase 2, N = 24 | Phase 1 CR, 72%; phase 2 CR, 82% vs 67%; no difference if FFS | Neutropenia, 55% vs 8%; thrombocytopenia, 100% vs 33% |
| Vorinostat + R-ICE | Relapsed B-cell NHL or frontline PTCL or MCL | NCT00601718 | Completed; phase 1, N = 29 | ORR, 70% | Febrile neutropenia, 28%; infection, 28%; gastrointestinal, 31% |
| Drug . | Disease type . | NCT no. . | Enrollment status . | Response . | Grade 3/4 toxicities . |
|---|---|---|---|---|---|
| Vorinostat + R-DA-EPOCH vs R-DA-EPOCH | AIDS-related DLBCL | NCT01193842 | Active, not recruiting; phase 1/2, N = 90 | CR, 65% vs 77%; 1-y EFS, 75% vs 82% favoring R-EPOCH | Neutropenia, 44% vs 16%;thrombocytopenia, 27% vs 2% |
| Oral azacitidine + R-CHOP | DLBCL/FL/tFL | NCT02343536 | Active, not recruiting; phase 1, N = 59 | ORR, 95%; CR, 88%; 1-y PFS, 86%; 2-y PFS, 80%; | Neutropenia, 52%; febrile neutropenia, 25%; anemia, 17% |
| Vorinostat + R-CHOP | DLBCL | NCT00972478 | Active, not recruiting; phase 1/2, N = 72 | 2-y PFS, 72%; OS, 86% | Febrile neutropenia, 38%; sepsis, 19%; neutropenia, 60%; anemia, 35%; thrombocytopenia, 35% |
| Vorinostat + R-CEP | DLBCL in elderly | NCT00667615 | Completed; phase 1/2, N = 30 | CR, 35%; median PFS, 9.2 mo | Neutropenia, 15%; thrombocytopenia, 12%; hyperglycemia, 11% |
| Azacitidine + R-CHOP | DLBCL | NCT01004991 | Completed; phase 1/2, N = 12 | CR, 92% | Neutropenia, 100%; febrile neutropenia, 25% |
| Tazemetostat + R-CHOP | DLBCL | NCT02889523 | Completed; phase 1b, N = 17 | Metabolic CR, 77% | Neutropenia, 47%; leukopenia, 29%; constipation, 24% |
| Decitabine + COP | DLBCL | NCT03494296 | Recruiting | ||
| Decitabine + R-DHAP | DLBCL | NCT03579082 | Recruiting | ||
| Oral azacitidine + R-ICE | DLBCL | NCT03450343 | Recruiting | ||
| Oral azacitidine + CHOP | PTCL | NCT03542266 | Active, not recruiting | ||
| Romidepsin + CHOP | PTCL | NCT01796002 | Active, not recruiting; phase 1/2, N = 37 | CR, 51%; ORR, 68%; 18-mo PFS, 77% | Neutropenia, 89%; thrombocytopenia, 78%; febrile neutropenia, 14%; pneumonia, 11% |
| Romidepsin + gemcitabine | PTCL | NCT01822886 | Completed; phase 2, N = 20 | CR, 15%; ORR, 30%; 2-y OS, 50% | Thrombocytopenia, 60%; neutropenia, 50%; anemia, 20% |
| Chidamide + CHOP | PTCL | NCT02809573 | Completed; phase 1, N = 30 | CR, 35%; 1-y PFS, 54%; 1-y OS, 100% | Leukopenia, 90%; neutropenia, 83%; lymphocytopenia, 40% |
| Romidepsin + GDP | PTCL | NCT01846390 | Completed; phase 1, N = 20 | ORR, 50%; median PFS, 2.3 mo; median OS, 7.16 mo | Thrombocytopenia, 55%; neutropenia, 30%; anemia, 30% |
| Romidepsin + ICE | PTCL | NCT01590732 | Completed; phase 1, N = 18 | CR, 13%; ORR, 93%; median PFS, 10 mo | Thrombocytopenia, 83%; anemia, 50%; neutropenia, 44% |
| Belinostat + CHOP | PTCL | NCT01839097 | Completed; phase 1, N = 21 | CR, 72%; ORR, 89% | Neutropenia, 26%; anemia, 22% |
| Vorinostat + CHOP | PTCL | NCT00787527 | Completed; phase 1, N = 14 | CR, 93%; 2-y PFS, 79% | Neutropenia, 76% |
| Romidepsin + CHOEP | PTCL | NCT02223208 | Recruiting | ||
| Decitabine + CHOP | PTCL | NCT035537 | Not yet recruiting | ||
| Panobinostat + ICE | HL | NCT0116936 | Completed; phase 1, N = 29; phase 2, N = 24 | Phase 1 CR, 72%; phase 2 CR, 82% vs 67%; no difference if FFS | Neutropenia, 55% vs 8%; thrombocytopenia, 100% vs 33% |
| Vorinostat + R-ICE | Relapsed B-cell NHL or frontline PTCL or MCL | NCT00601718 | Completed; phase 1, N = 29 | ORR, 70% | Febrile neutropenia, 28%; infection, 28%; gastrointestinal, 31% |
ASCT, autologous stem cell transplant; CHOEP, prednisone, Oncovin (vincristine), cyclophosphamide, hydroxydoxorubicin, etoposide; COP, cyclophosphamide, Oncovin (vincristine), prednisone; CR, complete response; DHAP, dexamethasone, high-dose cytarabine platinum-based, chemotherapy; DLBCL, diffuse large B-cell lymphoma; EFS, event-free survival; FFS, failure-free survival; FL, follicular lymphoma; GDP, gemcitabine, dexamethasone, cisplatin; HL, Hodgkin lymphoma; ICE, ifosfamide, carboplatinum, etoposide; MCL, mantle cell lymphoma; NHL, non-Hodgkin lymphoma; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PTCL, peripheral T-cell lymphoma; R, rituximab; R-CEP, rituximab, prednisone, etoposide, cyclophosphamide; R-CHOP, rituximab, prednisone, Oncovin (vincristine), cyclophosphamide, hydroxydoxorubicin; R-DA-EPOCH, rituximab, dose-adjusted etoposide, prednisone, Oncovin (vincristine), cyclophosphamide, hydroxydoxorubicin; tFL, transformed follicular lymphoma.