A Study of BGB-11417 in Participants With Myeloid Malignancies

Description

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

Conditions

Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm

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Study Overview

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Study Details

Study overview

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies

A Study of BGB-11417 in Participants With Myeloid Malignancies

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

Columbia

Maryland Oncology Hematology, Pa, Columbia, Maryland, United States, 21044

Pittsburgh

Upmc Hillman Cancer Center(Univ of Pittsburgh), Pittsburgh, Pennsylvania, United States, 15232

Houston

Md Anderson Cancer Center, Houston, Texas, United States, 77030

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
  • * AML, nonacute promyelocytic leukemia
  • * MDS
  • * MDS/MPN
  • 2. Eastern Cooperative Oncology Group performance status of 0 to 2.
  • 3. Adequate organ function defined as:
  • * Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)
  • * Adequate liver function
  • 4. Life expectancy of \> 12 weeks.
  • 5. Ability to comply with the requirements of the study.
  • 1. A diagnosis of acute promyelocytic leukemia.
  • 2. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)
  • 3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
  • 4. Prior therapy with a B-cell lymphoma-2 inhibitor
  • 5. Known central nervous system involvement by leukemia.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Record Dates

2028-02-08