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Evaluation of the Combination of Romidepsin and Carfilzomib in Relapsed/Refractory Peripheral T Cell Lymphoma Patients

NCT03141203 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-18

No results posted yet for this study

Summary

This is a multicentre phase I/II trial looking at the combination of romidepsin and carfilzomib.

The aim of the phase I part is to determine the maximum tolerated dose (MTD) of the combination. This part will recruit up to 27 patients, plus possibly an additional 3 patients at the MTD.

The aim of the phase II part is to assess the activity of the combination at the maximum tolerated dose in 28 patients (including at least 6 patients treated at the MTD from phase I).

Patients will receive 8 cycles of romidepsin with carfilzomib and response will be assessed every second cycle. Patients will be followed up for progression and survival until the end of the trial.

Conditions

  • Peripheral T Cell Lymphoma

Interventions

DRUG

Romidepsin

10mg vial for Injection

DRUG

Carfilzomib

60mg vial for injection

Sponsors & Collaborators

  • Bloodwise

    collaborator OTHER

  • Celgene

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Graham Collins, MBBS DPhil · Churchill Hospital, Oxford, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-13
Primary Completion
2020-08-31
Completion
2021-09-23
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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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 NCT03141203 on ClinicalTrials.gov