This study employs a 1:1 randomization of patients to receive romidepsin alone verses romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75% improvement in progression free survival (PFS) among patients receiving the combination compared to single agent romidepsin.
Name: Romidepsin
Description: Intravenous administration on a 28 day cycleType: DrugRomidepsin + Pralatrexate Combination Arm Romidepsin Arm
Name: Pralatrexate
Description: Intravenous administration on a 28 day cycleType: DrugRomidepsin + Pralatrexate Combination Arm
Description: Compare the progression free survival (PFS) in patients with R/R PTCL treated with romidepsin versus the combination of romidepsin plus pralatrexate.
Measure: Progression Free Survival Time: up to 3 yearsDescription: Contrast the complete response rate (CR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Complete Response (CR) Time: up to 3 yearsDescription: Contrast the duration of response (DOR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Duration of response (DOR) Time: up to 3 yearsDescription: Contrast the overall survival (OS)for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Overall survival (OS) Time: up to 3 yearsDescription: Contrast the overall response rate (ORR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Overall response rate (ORR) Time: up to 3 yearsDescription: TTP measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.
Measure: Time to Treatment Progression (TTP) Time: up to 3 yearsDescription: TTR measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.
Measure: Time to Relapse (TTR) Time: up to 3 yearsDescription: Describe the maximum number of cycles and planned dose intensity of all drugs in both arms in patients with R/R PTCL treated with romidepsin or romidepsin plus pralatrexate.
Measure: Maximum Number of Treatment Cycles Time: Up to 6 monthsAllocation: Randomized
Parallel Assignment
There are 2 SNPs
There were 3 dose-limiting toxicities (DLTs) in cohort 4 (pralatrexate 20mg/m2 & romidepsin 12mg/m2given weekly x 2 Q21D) consisting of 2 Grade 3 oral mucositis and 1 Grade 4 sepsis. --- Q21D ---
The every other week (QOW Q28D) schedule had no DLTs at equivalent and higher doses. --- Q28D ---