Study on Romidepsin and Lenalidomide for Untreated Peripheral T-Cell Lymphoma

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02232516

Provider View

This clinical trial is testing a new combination of drugs, romidepsin and lenalidomide, to see if they are safe and effective for treating patients with peripheral T-cell lymphoma (PTCL) who have not received any prior treatment for this cancer.

Patient Parameters

Program Overview

The aim of this study is to find out if the combination of two drugs, romidepsin and lenalidomide, can safely and effectively treat patients with peripheral T-cell lymphoma (PTCL) who have not been treated before. Currently, there is no standard treatment for PTCL, and the commonly used CHOP therapy can be hard to tolerate and is not very effective for most PTCL patients. Romidepsin is an HDAC inhibitor that works by interacting with DNA to stop tumor growth and is given through an IV. Lenalidomide is an immunomodulatory drug that affects tumor growth and survival and is taken as a pill.

Description

The study has several goals:

Primary Goals:

  • To see how well the combination of romidepsin and lenalidomide works in treating PTCL.

Secondary Goals:

  • To check the safety of using romidepsin and lenalidomide together.
  • To further evaluate how effective the combination is.
  • To see if the treatment can delay the need for more aggressive chemotherapy.

Tertiary Goals:

  • To compare different imaging methods (PET/CT vs. CT) in PTCL.
  • To validate a new model for predicting outcomes in newly diagnosed PTCL.
  • To study tumor samples for markers that might predict treatment success.

Treatment Plan:

  • Patients will receive romidepsin through an IV on days 1, 8, and 15, and take lenalidomide pills daily from days 1 to 21.
  • This treatment cycle repeats every 28 days for up to a year, unless the disease progresses, side effects become too severe, or the patient chooses to stop.
  • After treatment, patients will have follow-up visits every 3 months for a year, then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of specific types of PTCL, such as Anaplastic Large Cell Lymphoma (ALK-negative) or Angioimmunoblastic T-cell Lymphoma.
  • Must have measurable disease by CT scan.
  • Must be 18 years or older, with certain health conditions or age criteria.
  • Must have adequate organ and bone marrow function based on specific blood tests.
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities.
  • Must agree to use effective contraception and undergo counseling about pregnancy risks.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Must not have had any other cancers for at least a year, with some exceptions.
  • Must be willing to sign an informed consent form and comply with study requirements.

Exclusion Criteria

  • Cannot have certain types of lymphoma, such as ALK-positive Anaplastic Large Cell Lymphoma or Adult T-cell Leukemia/Lymphoma.
  • Cannot have received prior systemic therapy for PTCL, except for short-term corticosteroids.
  • Cannot have had chemotherapy or radiotherapy within 4 weeks before starting the study.
  • Cannot have used other HDAC inhibitors or immunomodulatory drugs before.
  • Cannot be on other investigational treatments.
  • Cannot have lymphoma involving the central nervous system.
  • Cannot have uncontrolled illnesses, such as active infections or heart problems.
  • Cannot have HIV infection.
  • Cannot be pregnant or breastfeeding.
  • Cannot have a prolonged QT interval on an ECG test.

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