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Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL

NCT03355768 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-12-19

No results posted yet for this study

Summary

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.

Conditions

  • Lymphoma, T-Cell, Peripheral

Interventions

DRUG

Romidepsin

Intravenous administration on a 28 day cycle

DRUG

Pralatrexate

Intravenous administration on a 28 day cycle

Sponsors & Collaborators

Principal Investigators

  • Jennifer E Amengual, MD · Center for Lymphoid Malignancies Columbia University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2018-11-01
Completion
2018-11-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355768 on ClinicalTrials.gov