Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
TERMINATED
NCT01947140
PHASE1/PHASE2

Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies

Sponsor: Jennifer Amengual

View on ClinicalTrials.gov

Summary

This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate are in patients with lymphoid malignancies and to determine the dose of the combination of drugs that is safest. If the combination is determined to be safe, the study will continue accrual patients with peripheral T-Cell lymphoma (PTCL).

Official title: Phase I/IIA Study of the Novel Antifolate Agent Pralatrexate in Combination With the Histone Deacetylase Inhibitor Romidepsin for the Treatment of Patients With Peripheral T-cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

57

Start Date

2013-09-09

Completion Date

2022-09-01

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DRUG

Pralatrexate

Phase I - Schedule A: Intravenous drug given on days 1 and 8 of each 21 day cycle Schedule B: Intravenous drug given on days 1 and 15 of each 28 day cycle Dose escalation from 10 mg/m2 to 25 mg/m2 Phase II - 25 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28 day cycle.

DRUG

Romidepsin

Phase I - Schedule A: Intravenous drug given on days 1 and 8 of each 21 day cycle Schedule B: Intravenous drug given on days 1 and 15 of each 28 day cycle Dose escalation from 12 mg/m2 to 14 mg/m2. Phase II - 12 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28 day cycle.

Locations (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Columbia University Irving Medical Center

New York, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States