Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies

  • STATUS
    Recruiting
  • days left to enroll
    71
  • participants needed
    160
  • sponsor
    BeiGene
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Updated on 19 February 2024
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Summary

The purpose of this study is to determine the safety, tolerability; Recommended Phase 2 Dose (RP2D), optimal ramp-up dosing schedule; and to evaluate preliminary activity of BGB-11417 monotherapy.

Details
Condition Mature B-Cell Malignancies
Age 18years - 100years
Treatment BGB-11417
Clinical Study IdentifierNCT04277637
SponsorBeiGene
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Part 1 Marginal Zone lymphoma (MZL), follicular lymphoma (FL), diffuse large
B-cell lymphoma (DLBCL) or transformed B-cell NHL (excluding Richters
Transformation) that has relapsed or is refractory to at least 1 prior therapy
Part 2 (CLL/SLL Ramp-up)
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that
relapsed or been refractory to at least 1 prior therapy
Part 2 (Expansion Cohorts)
Marginal Zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell
lymphoma (DLBCL) or transformed B-cell NHL (excluding Richters Transformation)
that has relapsed or is refractory to at least 1 prior therapy

Exclusion Criteria

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 or breast, or localized Gleason score 6 prostate
Known central nervous system (CNS) involvement by lymphoma/leukemia
Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
Prior autologous stem cell transplant unless 3 months after transplant
Prior allogeneic stem cell transplant
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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