Status:
Recruiting
Disease Site:
Lymphoma
Phase:
Official Title:
A052101, RANDOMIZED PHASE 3 TRIAL OF CONTINUOUS VS. INTERMITTENT MAINTENANCE THERAPY WITH ZANUBRUTINIB AS UPFRONT TREATMENT IN OLDER PATIENTS WITH MANTLE CELL LYMPHOMA
NCT ID:
NCT#05976763
Link to Full Details:
Description:
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.
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression
- Stage I-IV
- Presence of measurable disease
- No prior systemic treatment for mantle cell lymphoma
- No prior radiation treatment for Stage 1 MCL
- No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody
- No prior stem cell transplant
- Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day for up to 7 days
- Age ≥70 years OR >60 to <70 years with comorbidities precluding autoSCT