Study on Rituximab and Venetoclax for Untreated Marginal Zone Lymphoma

Sponsor: Gottfried von Keudell, MD PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06510309

Provider View

This clinical trial is exploring whether a combination of two drugs, rituximab and venetoclax, can effectively treat patients with Marginal Zone Lymphoma (MZL) who have not received any prior treatment.

Patient Parameters

Program Overview

The aim of this study is to test if using rituximab and venetoclax together can help treat Marginal Zone Lymphoma (MZL) in patients who have not yet undergone any chemotherapy. Rituximab is already approved for treating MZL, while venetoclax is approved for other conditions but not yet for MZL. Participants will undergo various procedures, including scans, blood tests, and biopsies, and will receive the study treatment for up to 24 months, with follow-up for an additional year. Approximately 33 people are expected to participate in this study, which is funded by Abbvie, Inc.

Description

This study is a Phase II trial focusing on the combination of rituximab and venetoclax for patients with Marginal Zone Lymphoma (MZL) who have not previously received chemotherapy. The goal is to determine if this combination is effective in treating MZL. While rituximab is approved for MZL, venetoclax is not yet approved for this specific use. Participants will be screened for eligibility and will undergo various tests, including CT, MRI, and PET scans, blood tests, and biopsies. They will receive the study treatment for up to 24 months and will be monitored for one year after stopping the treatment. The study aims to enroll about 33 participants and is funded by Abbvie, Inc., which provides venetoclax for the study.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Marginal Zone Lymphoma (MZL).
  • Must have measurable disease, such as a lymph node larger than 1.5 cm or an enlarged spleen.
  • For intestinal MALT lymphoma, the disease must be detectable by specific medical procedures.
  • For gastric MALT lymphoma, patients must be negative for H. pylori or have failed H. pylori eradication treatment.
  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have a life expectancy of more than 2 years.
  • Must meet specific blood and organ function criteria.
  • Must be able to understand and sign a consent form.
  • Must be able to swallow pills.
  • HIV-positive patients are eligible if their condition is well-controlled.
  • Patients with certain hepatitis B conditions are eligible if specific criteria are met.

Exclusion Criteria

  • Cannot have had prior systemic therapy, including rituximab.
  • Cannot have had prior radiation therapy, except under specific conditions.
  • Cannot have had prior treatment with ibrutinib or other BTK inhibitors.
  • Cannot have certain types of MZL unless unfit for radiation therapy.
  • Cannot have uncontrolled illnesses or infections.
  • Cannot have uncontrolled hepatitis B, C, or HIV infections.
  • Pregnant or breastfeeding women are excluded due to potential risks.
  • Cannot have taken certain medications that interact with venetoclax within 7 days before starting the study.

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