Phase II Study of Venetoclax and Rituximab as First Treatment in Older Adults with Mantle Cell Lymphoma

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05025423

Provider View

This clinical trial is testing a new treatment combination of venetoclax and rituximab for patients over 60 with mantle cell lymphoma who have not received any prior treatment. The study aims to see if this combination can effectively treat the cancer without the need for chemotherapy.

Patient Parameters

Program Overview

The study is exploring whether using venetoclax and rituximab together can provide a good response in older patients with mantle cell lymphoma, without the side effects of chemotherapy. The trial will involve patients over 60 who have not been treated for this type of cancer before. The main goal is to see if this combination can achieve a high rate of cancer response, as measured by scans, without using chemotherapy.

Description

For younger patients with mantle cell lymphoma, intensive chemotherapy and rituximab followed by a stem cell transplant is often used to keep the cancer away for a longer time. However, this approach is not a cure and can have significant side effects. For older patients who cannot have a stem cell transplant, chemotherapy and rituximab can help, but also come with many side effects. Venetoclax has shown promise in treating mantle cell lymphoma on its own, with fewer side effects.

This study is testing if starting treatment with venetoclax and rituximab can achieve similar results to traditional chemotherapy, but with fewer side effects. Researchers believe that patients who respond well to this treatment may continue to do well even after stopping venetoclax.

The trial will include 40 participants over the age of 60 who are not suitable for aggressive treatment. They will receive venetoclax and rituximab for up to 12 cycles, each lasting 4 weeks. If the cancer does not respond or worsens after 4 cycles, participants will be removed from the study to receive standard chemotherapy. If there is no complete response after 8 cycles, additional chemotherapy with bendamustine will be added.

This is the first study to use venetoclax and rituximab as the initial treatment for mantle cell lymphoma. Venetoclax has shown strong results in treating relapsed cases, making it a promising option for initial treatment without chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of mantle cell lymphoma.
  • Age 60 or older.
  • Must not have received any previous treatment for mantle cell lymphoma and need treatment as determined by a doctor.
  • Must be in relatively good health, with a performance status score between 0 and 3.
  • Must have adequate bone marrow function without needing growth factors:
    • Neutrophil count of at least 1000/μL.
    • Platelet count of at least 75,000/mm3 without recent transfusion.
    • Hemoglobin level of at least 9.0 g/dL.
  • Must have adequate kidney and liver function based on specific blood tests:
    • Creatinine clearance of at least 40 mL/min.
    • Liver enzymes (AST and ALT) no more than 3 times the upper limit of normal.
    • Bilirubin no more than 1.5 times the upper limit of normal, unless due to Gilbert's Syndrome.
  • Female participants must not be pregnant and must use effective birth control methods.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have a specific aggressive form of mantle cell lymphoma known as blastoid-variant.
  • Need immediate treatment to reduce tumor size.
  • Have cancer that has spread to the brain or spinal cord.
  • Have early-stage mantle cell lymphoma (Ann Arbor stage I or contiguous stage II).
  • Have an uncontrolled infection.
  • Have HIV infection.
  • Test positive for active Hepatitis B or C infections.
  • Require the use of the blood thinner warfarin.
  • Have received a live virus vaccine within 28 days before starting the study.
  • Are pregnant or breastfeeding.

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