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

This study is currently recruiting participants.
Verified November 2017 by BeiGene
Sponsor:
ClinicalTrials.gov Identifier:
NCT03332017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
BeiGene
  Purpose
The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111plus obinutuzumab versus obinutuzumab alone in subjects with relapsed/refractory non-Hodgkin follicular lymphoma.

Condition Intervention Phase
Relapsed/Refractory Follicular Non-Hodgkin Lymphoma Drug: BGB-3111 Drug: obinutuzumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by BeiGene:

Primary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: up to 3 years ]

Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: up to 3 years ]
  • Duration of response (DOR) [ Time Frame: up to 3 years ]
  • Time to response (TTR) [ Time Frame: up to 3 years ]
  • Incidence, timing, severity of treatment-emergent AEs [ Time Frame: up to 3 years ]
    Safety and Tolerability


Estimated Enrollment: 210
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Approximately 140 subjects to receive BGB-3111 and obinutuzumab
Drug: BGB-3111
BGB-3111 will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
Drug: obinutuzumab
Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks. 1 cycle = 28 days.
Other Name: Gazyva
Experimental: Arm B
Approximately 70 subjects to receive obinutuzumab
Drug: obinutuzumab
Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks. 1 cycle = 28 days.
Other Name: Gazyva

Detailed Description:
This is an open-label, randomized active control study of BGB-3111 plus obinutuzumab versus obinutuzumab alone in subjects with relapsed or refractory follicular lymphoma. Randomization is 2:1 and subjects will be stratified by the number of prior lines of therapy (2 - 3 vs > 3) and rituximab-refractory status. 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All subjects

  1. Histologically confirmed diagnosis of B-cell follicular lymphoma based on the 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. 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 subjects 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.

Exclusion Criteria: All subjects

  1. Prior exposure to a 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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332017


Contacts
Contact: William Reed, MD 781-801-1800 clinicaltrials@beigene.com
Contact: Jennifer Stearn, PhD 781-801-1800 clinicaltrials@beigene.com

Locations
United States, Nevada
Comprehensive Cancer Centers Recruiting
Las Vegas, Nevada, United States, 89014
Contact: Edwin Kingsley, MD         
Principal Investigator: Edwin Kingsley, MD         
Sponsors and Collaborators
BeiGene
  More Information

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03332017     History of Changes
Other Study ID Numbers: BGB-3111-212
First Submitted: October 31, 2017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BeiGene:
Relapsed/Refractory Follicular non-Hodgkin Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Obinutuzumab
Antineoplastic Agents