Back to resultsStudy Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma
Primary Purpose
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
zanubrutinib
bendamustine
rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Mantle Cell Lymphoma; Non-Hodgkin Lymphoma focused on measuring MCL, NHL
Eligibility Criteria
Key Inclusion Criteria:
- ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
- Histologically confirmed diagnosis of MCL
- No prior systemic treatments for MCL
- Measurable disease by CT/MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate marrow and organ function
Key Exclusion Criteria:
- Known central nervous system involvement by lymphoma
- Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
- Clinically significant cardiovascular disease
- History of severe bleeding disorder
- Unable to swallow capsules or disease significantly affecting gastrointestinal function
- Active fungal, bacterial and/or viral infection requiring systemic therapy
- Requires ongoing treatment with a strong CYP3A inhibitor or inducer
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- National Hospital Organization Nagoya Medical CenterRecruiting
- Toyohashi Municipal HospitalRecruiting
- Chiba Cancer CenterRecruiting
- Kurume University HospitalRecruiting
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors HospitalRecruiting
- Kanagawa Cancer CenterRecruiting
- Yokohama Municipal Citizens HospitalRecruiting
- National Hospital Organization Kumamoto Medical CenterRecruiting
- Tohoku University HospitalRecruiting
- Kurashiki Central HospitalRecruiting
- Osaka Red Cross HospitalRecruiting
- National Cancer Center HospitalRecruiting
- University Hospital, Kyoto Prefectural Univ of MedicineRecruiting
- National Hospital Organization Okayama Medical CenterRecruiting
- Osaka Metropolitan University HospitalRecruiting
- Tokyo Medical and Dental University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
zanubrutinib plus rituximab
bendamustine plus rituximab
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) determined by independent central review
Secondary Outcome Measures
PFS by investigator
Overall response rate (ORR)
Duration of response (DOR)
Overall survival (OS)
Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire
PROs as assessed by the EORTC QLQ-C30 questionnaire
Occurrence and severity of treatment-emergent adverse events (safety and tolerability)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04002297
Brief Title
Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Keywords
MCL, NHL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
zanubrutinib plus rituximab
Arm Type
Experimental
Arm Title
bendamustine plus rituximab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
zanubrutinib
Other Intervention Name(s)
BGB-3111, Brukinsa
Intervention Description
Administered as two 80 mg capsules by mouth twice a day
Intervention Type
Drug
Intervention Name(s)
bendamustine
Intervention Description
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) determined by independent central review
Time Frame
Up to 7 years
Secondary Outcome Measure Information:
Title
PFS by investigator
Time Frame
Up to 7 years
Title
Overall response rate (ORR)
Time Frame
Up to 7 years
Title
Duration of response (DOR)
Time Frame
Up to 7 years
Title
Overall survival (OS)
Time Frame
Up to 7 years
Title
Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire
Time Frame
Up to 7 years
Title
PROs as assessed by the EORTC QLQ-C30 questionnaire
Time Frame
Up to 7 years
Title
Occurrence and severity of treatment-emergent adverse events (safety and tolerability)
Time Frame
Up to 7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
Histologically confirmed diagnosis of MCL
No prior systemic treatments for MCL
Measurable disease by CT/MRI
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate marrow and organ function
Key Exclusion Criteria:
Known central nervous system involvement by lymphoma
Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
Clinically significant cardiovascular disease
History of severe bleeding disorder
Unable to swallow capsules or disease significantly affecting gastrointestinal function
Active fungal, bacterial and/or viral infection requiring systemic therapy
Requires ongoing treatment with a strong CYP3A inhibitor or inducer
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1-877-828-5568
Email
clinicaltrials@beigene.com
Facility Information:
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoyashi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyohashi Municipal Hospital
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba Cancer Center
City
Chibashi
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
City
Hiroshimashi
State/Province
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Cancer Center
City
Yokohamashi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama Municipal Citizens Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2408555
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamotoshi
State/Province
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendaishi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurashiki Central Hospital
City
Kurashikishi
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Red Cross Hospital
City
Osakashi
State/Province
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Chuoku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital, Kyoto Prefectural Univ of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
32985902
Citation
Dreyling M, Tam CS, Wang M, Smith SD, Ladetto M, Huang H, Novotny W, Co M, Romano A, Holmgren E, Huang J, Gouill SL. A Phase III study of zanubrutinib plus rituximab versus bendamustine plus rituximab in transplant-ineligible, untreated mantle cell lymphoma. Future Oncol. 2021 Jan;17(3):255-262. doi: 10.2217/fon-2020-0794. Epub 2020 Sep 28.
Results Reference
derived
Learn more about this trial
Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma
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