Patient characteristics, toxicity, and outcomes as a function of cohort
| Cohort . | Patient . | Disease subtype . | Prior lines of therapies/past romidepsin or pralatrexate . | Toxicities . | Best response . |
|---|---|---|---|---|---|
| 1: 10 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1, 8, and 15 (Q28) | 1 | ALCL ALK(−), multiple myeloma, MF | 6 (ASCT) | No DLT | CR |
| 2 | Hodgkin lymphoma | 14 (ASCT) | No DLT | SD | |
| 3 | Intestinal T-cell lymphoma | 1/romidepsin | No DLT | PR | |
| 2A: 15 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 8 (Q21) | 1 | T-cell lymphoma | 2 | No DLT | PR |
| 2 | ATLL | 2 | No DLT | CR | |
| 3 | Follicular lymphoma | 4/pralatrexate | No DLT | PR | |
| 2B: 15 mg/2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 15 (Q28) | 1 | CD4+ T-cell lymphoma | 1 | No DLT | PR |
| 2 | Follicular lymphoma | 9 | No DLT | NE | |
| 3 | Follicular lymphoma | 3 | No DLT | PR | |
| 3A: 15 mg/m2 pralatrexate and 14 mg/m2 romidepsin, days 1 and 8 (Q21) | 1 | SPTL-AB | 2 | DLT (pancytopenia, Plts = 4) | PR (PET neg) |
| 2 | Burkitt lymphoma | 3 | DLT (neutropenia, ANC = 0.244) | POD | |
| 3 | Follicular lymphoma | 5 | DLT (thrombocytopenia, Plts = 17) | PR | |
| 3B: 15 mg/m2 pralatrexate and 14 mg/m2 romidepsin, days 1 and 15 (Q28) | 1 | PTCL | 2 | No DLT | CR |
| 2 | DLBCL, CML | 3 | DLT (thrombocytopenia, Plts = 10) | NE | |
| 3 | ALCL ALK(−) | 2 | DLT (thrombocytopenia, Plts = 3) | NE | |
| 4A: 20 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 8 (Q21) | 1 | Hodgkin lymphoma | 16 (ASCT)/romidepsin and pralatrexate | No DLT | POD |
| 2 | Sezary syndrome | 5/romidepsin | DLT (grade 3 oral mucositis) | POD | |
| 3 | ATLL | 3 | DLT (grade 4 sepsis) | NE | |
| 4 | ATLL | 3 | DLT (grade 3 oral mucositis) | PR | |
| 5 | CD30+ ALK(−) ALCL | 2 (ASCT) | No DLT | CR | |
| 4B: 20 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 15 (Q28) | 1 | Hodgkin lymphoma | 12 (ASCT and allo)/ romidepsin | No DLT | POD |
| 2 | BPDCN | 1 | No DLT | SD | |
| 3 | ATLL | 3 (ASCT) | No DLT | POD | |
| 5B: 25 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 15 (Q28) | 1 | ATLL | 2 | No DLT | PR |
| 2 | Follicular lymphoma | 2/romidepsin | No DLT | POD | |
| 3 | CTCL | 2/romidepsin | No DLT | SD | |
| 5B: safety expansion | 4 | NK T cell | 2 | No DLT | NE |
| 5 | Sezary syndrome | 5 | No DLT | NE | |
| 6 | ATLL | 1 | No DLT | SD |
| Cohort . | Patient . | Disease subtype . | Prior lines of therapies/past romidepsin or pralatrexate . | Toxicities . | Best response . |
|---|---|---|---|---|---|
| 1: 10 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1, 8, and 15 (Q28) | 1 | ALCL ALK(−), multiple myeloma, MF | 6 (ASCT) | No DLT | CR |
| 2 | Hodgkin lymphoma | 14 (ASCT) | No DLT | SD | |
| 3 | Intestinal T-cell lymphoma | 1/romidepsin | No DLT | PR | |
| 2A: 15 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 8 (Q21) | 1 | T-cell lymphoma | 2 | No DLT | PR |
| 2 | ATLL | 2 | No DLT | CR | |
| 3 | Follicular lymphoma | 4/pralatrexate | No DLT | PR | |
| 2B: 15 mg/2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 15 (Q28) | 1 | CD4+ T-cell lymphoma | 1 | No DLT | PR |
| 2 | Follicular lymphoma | 9 | No DLT | NE | |
| 3 | Follicular lymphoma | 3 | No DLT | PR | |
| 3A: 15 mg/m2 pralatrexate and 14 mg/m2 romidepsin, days 1 and 8 (Q21) | 1 | SPTL-AB | 2 | DLT (pancytopenia, Plts = 4) | PR (PET neg) |
| 2 | Burkitt lymphoma | 3 | DLT (neutropenia, ANC = 0.244) | POD | |
| 3 | Follicular lymphoma | 5 | DLT (thrombocytopenia, Plts = 17) | PR | |
| 3B: 15 mg/m2 pralatrexate and 14 mg/m2 romidepsin, days 1 and 15 (Q28) | 1 | PTCL | 2 | No DLT | CR |
| 2 | DLBCL, CML | 3 | DLT (thrombocytopenia, Plts = 10) | NE | |
| 3 | ALCL ALK(−) | 2 | DLT (thrombocytopenia, Plts = 3) | NE | |
| 4A: 20 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 8 (Q21) | 1 | Hodgkin lymphoma | 16 (ASCT)/romidepsin and pralatrexate | No DLT | POD |
| 2 | Sezary syndrome | 5/romidepsin | DLT (grade 3 oral mucositis) | POD | |
| 3 | ATLL | 3 | DLT (grade 4 sepsis) | NE | |
| 4 | ATLL | 3 | DLT (grade 3 oral mucositis) | PR | |
| 5 | CD30+ ALK(−) ALCL | 2 (ASCT) | No DLT | CR | |
| 4B: 20 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 15 (Q28) | 1 | Hodgkin lymphoma | 12 (ASCT and allo)/ romidepsin | No DLT | POD |
| 2 | BPDCN | 1 | No DLT | SD | |
| 3 | ATLL | 3 (ASCT) | No DLT | POD | |
| 5B: 25 mg/m2 pralatrexate and 12 mg/m2 romidepsin, days 1 and 15 (Q28) | 1 | ATLL | 2 | No DLT | PR |
| 2 | Follicular lymphoma | 2/romidepsin | No DLT | POD | |
| 3 | CTCL | 2/romidepsin | No DLT | SD | |
| 5B: safety expansion | 4 | NK T cell | 2 | No DLT | NE |
| 5 | Sezary syndrome | 5 | No DLT | NE | |
| 6 | ATLL | 1 | No DLT | SD |
ALCL, anaplastic large cell lymphoma; ALK, anaplastic lymphoma kinase; allo, allogeneic stem cell transplant; ANC, absolute neutrophil count; ASCT, autologous or stem cell transplant; ATLL, adult T-cell leukemia/lymphoma; CTCL, cutaneous T-cell lymphoma; DLBCL, diffuse large B-cell lymphoma; MF, mycosis fungoides; NE, not evaluable; NK, natural killer; PET neg, positron emission tomography negative; Plts, platelets; POD, progression of disease; Q, every; SD, stable disease.