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Study of Evaluate Efficacy and Safety of BGB-3111 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03206970
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This is a single-arm, open-label, multi-center Phase 2 study in subjects with histologically documented MCL who have no response or relapse after ≥ 1 but < 5 prior treatment regimen(s). The study is composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Mantle Cell Lymphoma Drug: BGB-3111 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Subjects With Refractory or Relapsed Mantle Cell Lymphoma (MCL)
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : February 15, 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: BGB-3111 Drug: BGB-3111
BGB-3111 160 mg will be administered orally BID. Daily treatment with BGB-3111 may be continued for up to 3 years until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor.




Primary Outcome Measures :
  1. the rate of objective response [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Up to 3 years ]
  2. Six-month progression-free survival rate [ Time Frame: Up to 3 years ]
  3. Duration of response (DOR) [ Time Frame: Up to 3 years ]
  4. Overall survival (OS) [ Time Frame: Up to 3 years ]
  5. The safety and tolerability of BGB-3111, measured by the incidence, timing, and severity of AEs [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnostic report has to include evidence for morphological and cyclin D1 or t (11; 14).
  2. Men and women, 18-75 years of age.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  4. Measurable disease by computed tomography/magnetic resonance imaging (CT/MRI).
  5. Received prior regimens for MCL.
  6. Documented failure to achieve any response, [stable disease (SD) or progressive disease during treatment] or documented progressive disease after response to the most recent treatment regimen.
  7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
  8. Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).
  9. Females of childbearing potential must agree to use highly effective forms of birth control throughout the course of the study and at least up to 90 days after last dose of study drug. Highly effective forms of birth control include abstinence, hysterectomy, bilateral oophorectomy with no menstrual bleeding for 6 months, intrauterine contraception, hormonal methods such as contraceptive injection, oral contraceptive, etc. Males must have undergone sterilization-vasectomy, or utilize a barrier method while the female partner utilizes the effective forms of birth control noted above.
  10. Life expectancy of > 4 months.
  11. Able to provide written informed consent and can understand and comply with the requirements of the study.

Exclusion Criteria:

  1. Current or history of central nervous system (CNS) lymphoma.
  2. Prior exposure to a BTK inhibitor before enrollment.
  3. Prior corticosteroids with anti-neoplastic intent within 7 days.
  4. Major surgery within 4 weeks of screening.
  5. Toxicity must recover from prior chemotherapy.
  6. History of other active malignancies within 2 years of study entry.
  7. Currently clinically significant active cardiovascular disease.
  8. QTcF > 450 msecs or other significant ECG abnormalities.
  9. Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
  10. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction [PCR]).
  11. Pregnant or lactating women.
  12. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study at risk.

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): NCT03206970


Locations
Show Show 17 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Jun Zhu, PhD Lymphoma Department of Beijing University Cancer Hospital

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03206970    
Other Study ID Numbers: BGB-3111-206
CTR20160888 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action