Study on Zanubrutinib, Bendamustine, and Rituximab for Untreated Waldenström Macroglobulinemia

Sponsor: Massachusetts General Hospital

Sponsor score: 0

ClinicalTrials ID:NCT06561347

Provider View

This clinical trial is testing a combination of three drugs—zanubrutinib, bendamustine, and rituximab—to see if they can effectively treat patients with Waldenström macroglobulinemia (WM) who have not received any prior treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—zanubrutinib, bendamustine, and rituximab—can help patients with Waldenström macroglobulinemia (WM) achieve a very good partial response or better. This study involves about 50 participants and will last for up to 15 cycles of treatment, with follow-up for up to 5 years. While zanubrutinib is approved for treating WM, the combination with bendamustine and rituximab is still being studied and is not yet approved for this specific use.

Description

This study is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new drug combination to see if it works for treating Waldenström macroglobulinemia (WM). The drugs being tested are zanubrutinib, bendamustine, and rituximab. While zanubrutinib is already approved for WM, the combination with bendamustine and rituximab is not yet approved and is considered investigational. Participants will receive treatment for up to 15 cycles and will be followed for up to 5 years to monitor their response and any side effects. About 50 people are expected to participate in this study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Waldenström macroglobulinemia (WM) based on specific medical criteria.
  • Have certain genetic markers related to WM, such as MYD88 and CXCR4 mutations.
  • Meet specific criteria for needing treatment, such as experiencing symptoms like fever, night sweats, fatigue, or weight loss.
  • Have not received any prior treatment for WM.
  • Adults aged 18 and older.
  • Have a performance status that allows for daily activities with some restrictions.
  • Women of childbearing potential must agree to use effective contraception during and after treatment.
  • Men must agree to use a condom during sexual contact with women of childbearing potential during and after treatment.
  • Meet specific blood and organ function requirements based on lab tests.
  • Able to attend study visits and follow the study protocol.
  • Willing to sign an informed consent form.

Exclusion Criteria

  • Have any serious medical or psychiatric conditions that would prevent participation in the study.
  • Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
  • Have known involvement of the central nervous system by WM.
  • Have a history of HIV or active hepatitis B or C infections.
  • Currently taking systemic immunosuppressant therapy, except for low-dose steroids.
  • Have active autoimmune anemia or thrombocytopenia.
  • Taking warfarin or similar medications.
  • Have received live vaccines within 4 weeks of starting the study.
  • Have active, uncontrolled infections or other significant health issues.
  • Have had major surgery within 4 weeks of starting the study.
  • Have a history of severe bleeding disorders or recent strokes.
  • Unable to swallow pills or comply with study requirements.
  • Have significant heart disease or uncontrolled heart conditions.
  • Have allergies to any of the study drugs.
  • Have a history of non-compliance with medical treatments.
  • Have had another cancer within the past 3 years, except for certain skin or localized cancers.
  • Have severe lung disease.
  • Have ongoing substance abuse issues or psychiatric conditions that would interfere with the study.
  • Taking medications that strongly affect liver enzymes.

Locations

FACILITYZIPCITYSTATE
Massachusetts General Hospital02114BostonMassachusetts
Beth Israel Deaconess Medical Center02215BostonMassachusetts
Dana Farber Cancer Institute02215BostonMassachusetts

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