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RecruitingLast updated: 9 January 2024

This phase III trial is trying to understand whether it is safer and more effective to combine chemotherapy and targeted therapy for the treatment of mantle cell lymphoma, or to use targeted therapy alone, in patients who are not eligible for a stem cell transplant and have not received prior treatmentA Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Clinical summary

Summary

Eligible patients will be randomised to receive zanubrutinib (a targeted therapy) OR bendamustine (chemotherapy) in combination with rituximab for the treatment of their cancer. Zanubrutinib will be administered as two 80 mg capsules by mouth twice a day; bendamustine will be administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6; and rituximab will be administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6.

Conditions

This trial is treating patients with mantle cell lymphoma

Cancer

Blood Cancers Haematological

Age

People65+

Phase

III

More information

Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Eligibility

Inclusion

  1. ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
  2. Histologically confirmed diagnosis of MCL
  3. No prior systemic treatments for MCL
  4. Measurable disease by CT/MRI
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  6. Adequate marrow and organ function

Exclusion

  1. Known central nervous system involvement by lymphoma
  2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
  3. Clinically significant cardiovascular disease
  4. History of severe bleeding disorder
  5. Unable to swallow capsules or disease significantly affecting gastrointestinal function
  6. Active fungal, bacterial and/or viral infection requiring systemic therapy
  7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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