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:

Active, not 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
ZanubrutinibBGB-3111, BrukinsaArm A
ObinutuzumabGazyvaArm A

Purpose

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.

Trial Arms

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

Eligibility Criteria

        Key Inclusion Criteria:

          1. Histologically confirmed diagnosis of B-cell follicular lymphoma

          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 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. Adequate renal and hepatic function.

        Key Exclusion Criteria:

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

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

          3. Evidence of transformation from follicular lymphoma to other aggressive histology.

          4. Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment

          5. Prior malignancy within the past 2 years, except for curatively treated 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.

        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:Overall response rate (ORR) as Assessed by Independent Central Review
Time Frame:up to 3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall response rate (ORR) as Assessed by the Investigator
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Progression free survival (PFS)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Complete Response Rate
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Complete Metabolic Response Rate
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Health-Related Quality of Life (HRQOL) as Assessed by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Time to response (TTR)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Occurrence and 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:Active, not recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • Relapsed/Refractory Follicular non-Hodgkin Lymphoma

Last Updated

August 23, 2021