Clinical Trials /

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

NCT03332017

Description:

The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
  • Official Title: An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: BGB-3111-212
  • SECONDARY ID: 2017-001552-54
  • NCT ID: NCT03332017

Conditions

  • Relapsed/Refractory Follicular Non-Hodgkin Lymphoma

Interventions

DrugSynonymsArms
BGB-3111Arm A
obinutuzumabGazyvaArm A

Purpose

The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.

Detailed Description

      This is an open-label, randomized active control study of BGB-3111 plus obinutuzumab versus
      obinutuzumab alone in participants with relapsed or refractory follicular lymphoma.
      Randomization is 2:1 and participants will be stratified by the number of prior lines of
      therapy (2 - 3 vs > 3),rituximab-refractory status and geographic region (China vs ex-China).
      The study will evaluate the efficacy, as measured by overall response rate by independent
      review, safety and tolerability. Pharmacokinetic profile of BGB-3111 and obinutuzumab
      combination therapy will also be evaluated
    

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalApproximately 140 subjects to receive BGB-3111 and obinutuzumab
  • BGB-3111
  • obinutuzumab
Arm BExperimentalApproximately 70 subjects to receive obinutuzumab
  • obinutuzumab

Eligibility Criteria

        Key Inclusion Criteria: All participants

          1. Histologically confirmed diagnosis of B-cell follicular lymphoma based on the World
             Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid
             tissue.

          2. ≥2 prior systemic treatments for follicular lymphoma.

          3. Previously received an anti-CD20 antibody and an appropriate alkylator-based
             combination therapy.

          4. Disease progression within 12 months after completion of most recent therapy or
             refractory disease.

          5. Presence of measurable disease.

          6. Availability of archival tissue confirming diagnosis.

          7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.

          8. Life expectancy ≥6 months.

          9. Adequate bone marrow function.

         10. Adequate renal and hepatic function.

         11. Females of childbearing potential and non-sterile males must agree to use highly
             effective methods of birth control throughout the course of study and at least up to
             90 days after last dosing, or 18 months after the last dose of obinutuzumab, whichever
             is longer.

         12. Male participants are eligible if vasectomized or if they agree to the use of barrier
             contraception in combination with other methods during the study treatment period and
             for ≥ 90 days after the last dose of BGB-3111.

         13. Ability to provide the written informed consent and can understand and comply with the
             requirements of the study.

        Key Exclusion Criteria: All participants

          1. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.

          2. Known central nervous system involvement by leukemia or lymphoma.

          3. No evidence of transformation from follicular lymphoma to other aggressive histology.

          4. No allogeneic hematopoietic stem cell transplantation within 12 months of enrollment

          5. Prior malignancy within the past 5 years, except for basal or squamous cell skin
             cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or
             localized Gleason score 6 prostate

          6. Clinically significant cardiovascular disease.

          7. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.

          8. Active fungal, bacterial or viral infection requiring systemic treatment.

          9. History of severe bleeding disorder.

         10. History of stroke or intracranial hemorrhage within 6 months before first study drug.

         11. Severe or debilitating pulmonary disease.

         12. Known human immunodeficiency virus (HIV) or active hepatitis B or C.

         13. Unable to swallow capsules or significant gastrointestinal disease that would
             interfere with drug absorption.

         14. Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or
             inducer.

         15. Pregnant or nursing females.

         16. Vaccination with live vaccine within 35 days prior to first dose.

         17. Ongoing drug or alcohol addiction.

         18. Hypersensitivity to BGB-3111, known ingredients of BGB-3111 or obinutuzumab.

         19. Participation in another therapeutic trial.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:up to 3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Time to response (TTR)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Incidence, timing, severity of treatment-emergent adverse events (TEAEs)
Time Frame:up to 3 years
Safety Issue:
Description:Safety and Tolerability

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • Relapsed/Refractory Follicular non-Hodgkin Lymphoma

Last Updated

January 22, 2020