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Report for Clinical Trial NCT03355768

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomized Study of Romidepsin Versus the Combination of Romidepsin Plus Pralatrexate in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

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.

NCT03355768 Lymphoma, T-Cell, Peripheral
MeSH:Lymphoma Lymphoma, T-Cell, Peripheral Lymphoma, T-Cell
HPO:Lymphoma T-cell lymphoma

2 Interventions

Name: Romidepsin

Description: Intravenous administration on a 28 day cycle
Type: Drug
Group Labels: 2

Romidepsin + Pralatrexate Combination Arm Romidepsin Arm

Name: Pralatrexate

Description: Intravenous administration on a 28 day cycle
Type: Drug
Group Labels: 1

Romidepsin + Pralatrexate Combination Arm


Primary Outcomes

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 years

Secondary Outcomes

Description: Contrast the complete response rate (CR) for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Complete Response (CR)

Time: up to 3 years

Description: Contrast the duration of response (DOR) for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Duration of response (DOR)

Time: up to 3 years

Description: Contrast the overall survival (OS)for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Overall survival (OS)

Time: up to 3 years

Description: Contrast the overall response rate (ORR) for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Overall response rate (ORR)

Time: up to 3 years

Description: 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 years

Description: 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 years

Description: 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 months

Purpose: Other

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 Q21D

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 ---


2 Q28D

The every other week (QOW Q28D) schedule had no DLTs at equivalent and higher doses. --- Q28D ---



HPO Nodes


HPO: