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出境医 / 临床实验 / Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma

Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma

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.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma Drug: zanubrutinib Drug: bendamustine Drug: rituximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2026
Arms and Interventions
Arm Intervention/treatment
Experimental: zanubrutinib plus rituximab Drug: zanubrutinib
Administered as two 80 mg capsules by mouth twice a day
Other Names:
  • BGB-3111
  • Brukinsa

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

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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

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.

Contacts and Locations

Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
Show Show 120 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Rebecca Elstrom, MD BeiGene
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date May 10, 2021
Actual Study Start Date  ICMJE August 21, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019) 		Progression-free survival (PFS) determined by independent central review [ Time Frame: Up to 7 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • PFS by investigator [ Time Frame: Up to 7 years ]
  • Overall response rate (ORR) [ Time Frame: Up to 7 years ]
  • Duration of response (DOR) [ Time Frame: Up to 7 years ]
  • Overall survival (OS) [ Time Frame: Up to 7 years ]
  • Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire [ Time Frame: Up to 7 years ]
  • PROs as assessed by the EORTC QLQ-C30 questionnaire [ Time Frame: Up to 7 years ]
  • Occurrence and severity of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Up to 7 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • PFS by investigator [ Time Frame: Up to 7 years ]
  • Overall response rate (ORR) [ Time Frame: Up to 7 years ]
  • Duration of response (DOR) [ Time Frame: Up to 7 years ]
  • Overall survival (OS) [ Time Frame: Up to 7 years ]
  • Patient-reported outcomes (PROs) as measured by the EQ-5D-5L questionnaire [ Time Frame: Up to 7 years ]
  • PROs as measured by the EORTC QLQ-C30 questionnaire [ Time Frame: Up to 7 years ]
  • Occurrence and severity of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Up to 7 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Intervention  ICMJE
  • Drug: zanubrutinib
    Administered as two 80 mg capsules by mouth twice a day
    Other Names:
    • BGB-3111
    • Brukinsa
  • 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
Study Arms  ICMJE
  • Experimental: zanubrutinib plus rituximab
    Interventions:
    • Drug: zanubrutinib
    • Drug: rituximab
  • Active Comparator: bendamustine plus rituximab
    Interventions:
    • Drug: bendamustine
    • Drug: rituximab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019) 		500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2026
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key 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

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   China,   France,   Germany,   Ireland,   Italy,   Japan,   Lithuania,   New Zealand,   Poland,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002297
Other Study ID Numbers  ICMJE BGB-3111-306
2019-000413-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rebecca Elstrom, MD BeiGene
PRS Account BeiGene
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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