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History of Changes for Study: NCT04002297
Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Patients With Untreated Mantle Cell Lymphoma
Latest version (submitted April 25, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 27, 2019 None (earliest Version on record)
2 June 27, 2019 Outcome Measures and Study Status
3 September 17, 2019 Study Status
4 October 2, 2019 Study Status and Study Identification
5 October 28, 2019 Contacts/Locations and Study Status
6 February 4, 2020 Study Status and Study Identification
7 April 20, 2020 Contacts/Locations, Study Status, Eligibility, Outcome Measures, Study Description and Study Identification
8 May 26, 2020 Contacts/Locations, Arms and Interventions, Study Status and Eligibility
9 June 8, 2020 Study Status and Contacts/Locations
10 July 27, 2020 Study Status and Contacts/Locations
11 September 1, 2020 Study Status, Contacts/Locations and Arms and Interventions
12 October 8, 2020 Study Status and Contacts/Locations
13 April 21, 2021 Study Status and Contacts/Locations
14 May 6, 2021 Contacts/Locations and Study Status
15 June 20, 2021 Contacts/Locations and Study Status
16 August 31, 2021 Study Status
17 October 5, 2021 Study Status
18 November 17, 2021 Eligibility and Study Status
19 November 29, 2021 Contacts/Locations and Study Status
20 March 14, 2022 Study Status and Eligibility
21 April 25, 2022 Contacts/Locations and Study Status
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Study NCT04002297
Submitted Date:  June 27, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: BGB-3111-306
Brief Title: Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Patients 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
Secondary IDs: 2019-000413-36 [EudraCT Number]
Open or close this module Study Status
Record Verification: June 2019
Overall Status: Recruiting
Study Start: June 2019
Primary Completion: July 2021 [Anticipated]
Study Completion: August 2026 [Anticipated]
First Submitted: June 27, 2019
First Submitted that
Met QC Criteria:
June 27, 2019
First Posted: June 28, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
June 27, 2019
Last Update Posted: June 28, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BeiGene
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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 patients with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
Detailed Description:
Open or close this module Conditions
Conditions: Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Keywords: MCL, NHL
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: zanubrutinib plus rituximab Drug: zanubrutinib
BGB-3111 will be administered as two 80-mg capsules by mouth twice a day
Drug: rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Active Comparator: bendamustine plus rituximab Drug: bendamustine
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6
Drug: rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free survival (PFS) determined by independent central review
[ Time Frame: Up to 7 years ]

Secondary Outcome Measures:
1. PFS by investigator
[ Time Frame: Up to 7 years ]

2. Overall response rate (ORR)
[ Time Frame: Up to 7 years ]

3. Duration of response (DOR)
[ Time Frame: Up to 7 years ]

4. Overall survival (OS)
[ Time Frame: Up to 7 years ]

5. Patient-reported outcomes (PROs) as measured by the EQ-5D-5L questionnaire
[ Time Frame: Up to 7 years ]

6. PROs as measured by the EORTC QLQ-C30 questionnaire
[ Time Frame: Up to 7 years ]

7. Occurrence and severity of treatment-emergent adverse events (safety and tolerability)
[ Time Frame: Up to 7 years ]

Open or close this module Eligibility
Minimum Age: 65 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. ≥ 70 years of age at the time of informed consent, OR 65-69 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 Criteria:

  1. Known central nervous system involvement by lymphoma
  2. Patients 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
Open or close this module Contacts/Locations
Central Contact Person: BeiGene USA, Inc.
Telephone: 1-877-828-5568
Email: clinicaltrials@beigene.com
Locations: United States, Nevada
Comprehensive Cancer Centers of Nevada
[Recruiting]
Las Vegas, Nevada, United States, 89119
Open or close this module IPDSharing
Plan to Share IPD: Yes
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Links:
Available IPD/Information:

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