Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma

Conditions

• Mantle Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zanubrutinib — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV
• Patient Observation — OTHER
  Undergo observation
• Bone Marrow Biopsy — PROCEDURE
  undergo bone marrow biopsy
• Fludeoxyglucose F-18 — OTHER
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Esophagogastroduodenoscopy — PROCEDURE
  Undergo EGD
• Colonoscopy — PROCEDURE
  Undergo colonoscopy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.

Key Dates

Start date

Oct 20, 2023

Status verified

Jun 2026

Primary completion

Aug 31, 2038

Completion

Aug 31, 2038

Study Design

Enrollment

421 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Induction therapy (Zanubrutinib, rituximab)
  Patients receive zanubrutinib PO and rituximab IV on study. Patients undergo bone marrow biopsy and FDG PET/CT or CT throughout the trial. Patients may also undergo EDG and/or colonoscopy on study as clinically indicated. Patients may optionally undergo blood sample collection throughout the trial.
• Experimental: Arm A (Zanubrutinib)
  Patients receive zanubrutinib PO until first disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.
• Active Comparator: ARM B (Observation)
  Patients undergo observation until first disease progression and then receive zanubrutinib PO until second disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.

Primary Outcome Measure

Progression-free survival (PFS) 1 (Arm A) [ Time Frame: Time from randomization until the earlier of first progression or death from any cause, assessed up to 10 years ]

Central Contacts

• Anne Beaven, MD
  919-966-9268
  [email protected]
• Destin Carlisle
  773-702-8824
  [email protected]

Locations (237)

Find similar trials in Little Rock, AR

Related Studies

• A Long-term Extension Study of PCI-32765 (Ibrutinib)
  PHASE3 · Recruiting · Janssen Research & Development, LLC · Duarte, California
• Long-term Follow-up Study of Patients Receiving CAR-T Cells
  Recruiting · Medical College of Wisconsin · Milwaukee, Wisconsin
• SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
  Recruiting · Massive Bio, Inc. · Birmingham, Alabama
• Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
  Recruiting · Emory University · Atlanta, Georgia