Phase II Study of Brentuximab Vedotin for Relapsed or Refractory CD30 Low Mature T Cell Lymphoma

Sponsor: Deepa Jagadeesh

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02588651

Provider View

This clinical trial is testing the drug Brentuximab Vedotin in patients with mature T-cell lymphoma that has returned or not responded to previous treatments. The study aims to see if the drug can help control the disease, even when the cancer cells have low levels of a target called CD30.

Patient Parameters

Program Overview

This study involves patients with mature T-cell lymphoma (MTCL) that has either not responded to previous chemotherapy or has returned after treatment. The trial uses Brentuximab Vedotin, a drug approved by the FDA for certain diseases, to see if it can effectively treat this type of lymphoma. Brentuximab Vedotin is an antibody drug conjugate (ADC), which means it combines an antibody that targets cancer cells with a chemotherapy component that kills them. The antibody part targets a molecule called CD30, found on some cancer and immune cells. This study will test if Brentuximab Vedotin can work on lymphoma with low levels of CD30 and how the disease responds to the treatment.

Description

The main goal of this study is to determine how well Brentuximab Vedotin works in treating T-cell lymphoma with low levels of CD30. Researchers will look at the overall response rate, including complete and partial responses, to the drug. They will also evaluate how long the response lasts, the time patients remain free from disease progression, overall survival rates, and the time until treatment failure.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of relapsed or refractory CD30 low T-cell lymphoma, including specific subtypes like peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma, and others.
  • Must have received at least one prior chemotherapy regimen.
  • Must have a performance status score of 0-2, or 3 if the decrease is due to lymphoma.
  • Must have adequate organ function, including specific levels for bilirubin, liver enzymes, creatinine clearance, neutrophil count, and platelet count.
  • Must be at least 6 weeks from autologous stem cell transplantation and 3 months from allogeneic stem cell transplantation, with no immunosuppression or graft versus host disease.
  • Previous treatment with Brentuximab Vedotin is allowed if it was more than 6 months ago and the patient was not resistant to it.
  • Must have measurable disease on scans, including a tumor of at least 1.5 cm or specific conditions like splenomegaly or bone marrow involvement.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 6 months after treatment.
  • Men with partners of childbearing potential must agree to use effective contraception during and for 6 months after treatment.
  • Must be able to understand and sign a written informed consent document.

Exclusion Criteria

  • Cannot have anaplastic large cell lymphoma or certain skin lymphomas.
  • Cannot have been treated with Brentuximab Vedotin in the last 6 months or have been resistant to it.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had another cancer in the past 3 years, except for certain skin cancers or localized cancers treated with curative intent.
  • Cannot have severe peripheral neuropathy or certain neurological conditions.
  • Cannot have central nervous system involvement requiring treatment.
  • Cannot have a history of certain brain infections or recent heart attacks.
  • Cannot have active infections, liver disease, HIV, or serious heart conditions.
  • Cannot have had a severe allergic reaction to the drug components.
  • Cannot have had chemotherapy or investigational drugs within 2 weeks of starting the study treatment.

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