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Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma

NCT01738594 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-08-29

Study results available
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Summary

This randomized phase I trial studies the side effects and the best dose of carfilzomib when given together with or without romidepsin in treating patients with stage IA-IVB cutaneous T-cell lymphoma. Carfilzomib and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carfilzomib alone is more effective than when given together with romidepsin.

Conditions

  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IA Mycosis Fungoides/Sezary Syndrome
  • Stage IB Mycosis Fungoides/Sezary Syndrome
  • Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IIA Mycosis Fungoides/Sezary Syndrome
  • Stage IIB Mycosis Fungoides/Sezary Syndrome
  • Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IIIA Mycosis Fungoides/Sezary Syndrome
  • Stage IIIB Mycosis Fungoides/Sezary Syndrome
  • Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IVA Mycosis Fungoides/Sezary Syndrome
  • Stage IVB Mycosis Fungoides/Sezary Syndrome

Interventions

DRUG

carfilzomib

Given IV

DRUG

romidepsin

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Barbara Pro, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-22
Primary Completion
2016-10-11
Completion
2016-10-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01738594 on ClinicalTrials.gov