Status:
RECRUITING
A Study of BGB-11417 in Participants With Myeloid Malignancies
Lead Sponsor:
BeiGene
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- Key
- Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
- AML, nonacute promyelocytic leukemia
- MDS
- MDS/MPN
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- 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
- Life expectancy of \> 12 weeks.
- Ability to comply with the requirements of the study.
- Key
Exclusion
- A diagnosis of acute promyelocytic leukemia.
- 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)
- Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
- Prior therapy with a B-cell lymphoma-2 inhibitor
- Known central nervous system involvement by leukemia.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 8 2028
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04771130
Start Date
May 24 2021
End Date
February 8 2028
Last Update
November 12 2025
Active Locations (45)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010-3012
2
Tampa General Hospital
Tampa, Florida, United States, 33606-3571
3
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, United States, 15232-1309
4
Md Anderson Cancer Center
Houston, Texas, United States, 77030-3907