Mantle Cell Lymphoma; Non-Hodgkin Lymphoma Clinical Trial
Official 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
| Verified date | January 2024 |
| Source | BeiGene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
| Status | Active, not recruiting |
| Enrollment | 510 |
| Est. completion date | December 2027 |
| Est. primary completion date | March 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | Key Inclusion Criteria: 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 Key Exclusion Criteria: 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. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Chiba Cancer Center | Chibashi | Chiba |
| Japan | National Cancer Center Hospital | Chuoku | Tokyo |
| Japan | Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital | Hiroshimashi | Hiroshima |
| Japan | National Hospital Organization Kumamoto Medical Center | Kumamotoshi | Kumamoto |
| Japan | Kurashiki Central Hospital | Kurashikishi | Okayama |
| Japan | Kurume University Hospital | Kurume | Fukuoka |
| Japan | University Hospital, Kyoto Prefectural Univ of Medicine | Kyoto | |
| Japan | National Hospital Organization Nagoya Medical Center | Nagoyashi | Aichi |
| Japan | National Hospital Organization Okayama Medical Center | Okayama | |
| Japan | Osaka Metropolitan University Hospital | Osaka | |
| Japan | Osaka Red Cross Hospital | Osakashi | Osaka |
| Japan | Tohoku University Hospital | Sendaishi | Miyagi |
| Japan | Tokyo Medical and Dental University Hospital | Tokyo | |
| Japan | Toyohashi Municipal Hospital | Toyohashi | Aichi |
| Japan | Yokohama Municipal Citizens Hospital | Yokohama | Kanagawa |
| Japan | Kanagawa Cancer Center | Yokohamashi | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| BeiGene |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival (PFS) determined by independent central review | Up to 7 years | ||
| Secondary | PFS by investigator | Up to 7 years | ||
| Secondary | Overall response rate (ORR) | Up to 7 years | ||
| Secondary | Duration of response (DOR) | Up to 7 years | ||
| Secondary | Overall survival (OS) | Up to 7 years | ||
| Secondary | Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire | Up to 7 years | ||
| Secondary | PROs as assessed by the EORTC QLQ-C30 questionnaire | Up to 7 years | ||
| Secondary | Occurrence and severity of treatment-emergent adverse events (safety and tolerability) | Up to 7 years |