Study on Ixazomib and Romidepsin for Treating Peripheral T-cell Lymphoma (PTCL)

Sponsor: Ryan Wilcox

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03547700

Provider View

This clinical trial is testing a combination of two drugs, ixazomib and romidepsin, to see if they can help treat patients with Peripheral T-cell Lymphoma (PTCL) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if the combination of ixazomib and romidepsin can effectively treat patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL). The trial is divided into two phases: Phase I will test different doses to find the safest and most effective one, while Phase II will use the best dose from Phase I to further evaluate its effectiveness. Each treatment cycle lasts 28 days, and patients will continue treatment until their disease progresses, they experience unacceptable side effects, or they choose to withdraw from the study.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization for the release of personal health information.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must have a confirmed diagnosis of Peripheral T-cell Lymphoma (PTCL) and evidence of disease relapse after previous treatment.
  • Must have experienced disease progression after at least one prior treatment regimen.
  • Must have completed any prior cancer treatment at least 28 days before joining the study and recovered from any side effects.
  • Must have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Men must agree not to donate sperm during the study and for 90 days after treatment ends.
  • Must be able to understand and follow study procedures.

Exclusion Criteria

  • Have any significant illness or medical condition that could affect participation in the study.
  • Have an active infection requiring treatment.
  • Are pregnant or breastfeeding.
  • Have another active or progressing cancer, except for certain skin or cervical cancers.
  • Have active lymphoma in the central nervous system.
  • Have had major surgery or radiation therapy within 28 days before joining the study.
  • Have uncontrolled infections or certain viral infections.
  • Have gastrointestinal issues that affect the absorption of oral medications.
  • Have uncontrolled heart conditions or recent heart attacks.
  • Have a prolonged QT interval on an ECG.
  • Have received any investigational drug within 28 days before joining the study.
  • Have peripheral neuropathy of grade 2 or higher.
  • Have previously been treated with bortezomib, ixazomib, or romidepsin.
  • Are taking certain medications that affect liver enzymes within 14 days before joining the study.
  • Have any serious medical or psychiatric condition that could interfere with the study.
  • Have an allergy to any of the study medications.
  • Have had a stem cell transplant within 90 days before joining the study.

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