Study on Pembrolizumab and Brentuximab Vedotin for Treating Relapsed or Hard-to-Treat T-cell Lymphoma

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05313243

Provider View

This clinical trial is testing a combination of two drugs, pembrolizumab and brentuximab vedotin, to see if they can effectively treat T-cell lymphoma that has returned or is not responding to previous treatments. The study aims to achieve a response rate of about 65% in patients.

Patient Parameters

Program Overview

This study is exploring the effectiveness of combining two drugs, pembrolizumab and brentuximab vedotin, to treat patients with T-cell lymphoma that has either come back after treatment or has not responded to previous therapies. The trial will involve 43 participants and will assess how well the combination works over a series of treatment cycles. The goal is to see if this combination can help control the disease better than existing treatments.

Description

T-cell lymphoma is a type of cancer that affects the immune system and can be difficult to treat, especially when it returns or doesn't respond to initial treatments. This study focuses on two types of T-cell lymphoma: peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). These cancers are aggressive and often come back after treatment, making them challenging to manage.

The study is testing a new combination of drugs: pembrolizumab, which helps the immune system fight cancer, and brentuximab vedotin, which targets cancer cells directly. Researchers hope this combination will be more effective than current treatments, which often have limited success.

Participants will receive the drug combination for up to 16 cycles if their disease responds well. Pembrolizumab may be continued for an additional 19 cycles, totaling 35 cycles. The study will monitor participants' responses at specific intervals and adjust doses if necessary to manage side effects. The aim is to improve treatment outcomes for patients with relapsed or refractory T-cell lymphoma.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of T-cell Non-Hodgkin lymphoma (T-NHL).
  • Must have a type of T-cell lymphoma, such as peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma, or cutaneous T-cell lymphoma, among others.
  • Cancer must be CD30 positive (more than 1%) based on a previous biopsy.
  • Disease must have returned or not responded after at least one prior treatment.
  • For PTCL patients: Must have at least one measurable tumor 1.5 cm or larger.
  • Women must not be pregnant or breastfeeding and must agree to use contraception during and after treatment.
  • Men must agree to use contraception during and after treatment.
  • Must have adequate organ and bone marrow function based on recent tests.

Exclusion Criteria

  • Previous treatment with certain immune therapies like anti-PD-1 or anti-PD-L1 agents.
  • Diagnosis of adult T-cell leukemia/lymphoma (ATLL).
  • Recent treatment with other cancer therapies or participation in another clinical trial.
  • Pregnant or breastfeeding women.
  • Recent radiotherapy or history of lung disease requiring steroids.
  • Recent vaccination with live vaccines.
  • Active infections or history of severe heart or lung disease.
  • Known history of HIV, Hepatitis B, or Hepatitis C.
  • Other serious health conditions that could interfere with the study.
  • History of psychiatric or substance abuse disorders that could affect participation.
  • Recent stem cell transplant or active graft vs. host disease.
  • Severe peripheral neuropathy.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.