Evaluating BGB-11417 for treating myeloid malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of BGB-11417, both alone and in combination with azacitidine, in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It aims to establish the recommended Phase 2 dose and assess preliminary efficacy. Participants will be monitored for tolerability and organ function throughout the trial. The study is designed to provide insights into new treatment options for these serious blood disorders.

Why it matters

Who can join: the full rules

Key Inclusion 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.

Key Exclusion Criteria:

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.

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

Where it's running

• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• Upmc Hillman Cancer Center(Univ of Pittsburgh)
  Pittsburgh, Pennsylvania, United States Recruiting
• Md Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting
• Concord Repatriation General Hospital
  Concord, New South Wales, Australia Recruiting
• St George Hospital
  Kogarah, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.