A Study of BGB-11417 in Participants With Myeloid Malignancies

Launched by BEIGENE · Feb 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called BGB-11417 to see how safe it is, how well it works, and what the best dose is for treating certain blood cancers, specifically Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). The trial will look at BGB-11417 on its own and also in combination with another drug called azacitidine. Researchers are hoping to find out if this treatment can help people with these conditions.

To be eligible for the trial, participants need to have a confirmed diagnosis of AML, MDS, or a related disorder, and they should have a good performance status, meaning they can still carry out daily activities. They also need to have good kidney and liver function and a life expectancy of more than 12 weeks. The study is currently open for people aged 65 and older, regardless of gender. Participants can expect close monitoring during the trial, and their involvement will help researchers gather important information about this new treatment option.

Gender

ALL

Eligibility criteria

• 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.