For Healthcare Professionals

A Study of BGB-11417 in Participants With Myeloid Malignancies

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About the study

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) .
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:

Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:

  1. AML, nonacute promyelocytic leukemia
  2. MDS
  3. MDS/MPN
  4. Eastern Cooperative Oncology Group performance status of 0 to 2.

Adequate organ function defined as:

  1. Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)
  2. Adequate liver function
  3. Life expectancy of > 12 weeks.
  4. Ability to comply with the requirements of the study.

EXCLUSION CRITERIA

Key Exclusion Criteria:

  1. A diagnosis of acute promyelocytic leukemia.
  2. Prior malignancy within the past 2 years, except for curatively treated 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 or azacitidine except for participants who meet HMA-failure criteria
  5. Known central nervous system involvement by leukemia.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Acute Myeloid Leukemia,Myelodysplastic Syndromes,Myelodysplastic/Myeloproliferative Neoplasm

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

260

Est. Completion Date

Aug 31, 2025

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT04771130

Study number

BGB-11417-103

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