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Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies

NCT01998035 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-08-22

Study results available
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Summary

This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I followed by a disease focused phase II.

The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. The safety and toxicity of this combination will be evaluated throughout the entire study.

If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is established, the phase II part of the study will be initiated.

Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and romidepsin for patients with relapsed or refractory T-cell lymphomas.

Conditions

Interventions

DRUG

RomiDEPsin 10 MG/M2

Romidepsin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Romidepsin is classified as a "Histone Deacetylase Inhibitor". Dose escalation (10 mg/m2)

DRUG

Oral 5-Azacitidine 100 MG

A pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation (100 mg)

DRUG

Romidepsin 14 MG/M2

Romidepsin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Romidepsin is classified as a "Histone Deacetylase Inhibitor". Dose escalation (14 mg/m2)

DRUG

Oral 5-Azacitidine 200 MG

A pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation (200 mg)

DRUG

Oral 5-Azacitidine 300 MG

A pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation (300 mg)

Sponsors & Collaborators

Principal Investigators

  • Owen A. O'Connor, MD, Ph.D. · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2020-01-06
Completion
2020-01-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01998035 on ClinicalTrials.gov