A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)

Beat AML, LLC

Summary

This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. Patients with myeloid malignancies \[e.g. myelodysplastic syndrome (MDS) or other diseases\], will be allowed to enroll to Master protocol if there is an available sub-study.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Adults, age 60 years or older at the time of diagnosis unless in a specific known cytogenetic and genomic group for which treatment in Group A, B, or C is allowed by the sub-study where age 18 and older is allowed. In such case, waiting for Foundation Medicine test results would not be required to proceed with sub-study treatment. Patients \< 60 years old who are screened but do not fall within the cytogenetic and genomic open sub-studies would still be followed on the M1 Master Protocol and not considered screen fails. * Patients must be able to understand and provide w…

Interventions

Biological
Samalizumab (BAML-16-001-S1)
300 mg/m2, IV, on days 1, 3, and 24; followed by 300 mg/m2, IV, every 21 days for 2 years in the absence of toxicity or disease progression. Dose may be de-escalated to 150 mg/m2 or escalated to 600 mg/m2 based on occurrence of dose-limiting toxicity.
Biological
BI 836858 (BAML-16-001-S2)
20 mg/m2, IV, on days 9, 16, and 23 of a 28-day cycle; followed 20 by mg/m2, IV, on days 1, 8, 15 and 22 of each 28-day cycle for 2 years in the absence of toxicity or disease progression (reduced to monthly administration in event of complete response or complete response with incomplete blood count recovery). Dose may be escalated to a maximum dose of 320 mg/m2 or de-escalated to 10 mg/m2 based on occurrence of dose-limiting toxicity.
Other
Laboratory Biomarker Analysis
Molecular genomic assessment to assign patients to targeted therapy (sub-study) based on their specific subtype of acute myeloid leukemia
Drug
Daunorubicin (BAML-16-001-S1)
60 mg/m2, IV, on days 4, 5, and 6 of the induction cycle
Drug
Cytarabine (BAML-16-001-S1)

Locations (19)

Mayo Clinic Arizona
Phoenix, Arizona
UCLA Ronald Reagan Medical Center
Los Angeles, California
University of California, San Francisco
San Francisco, California
University of Colorado
Denver, Colorado
University of Florida Health Shands Cancer Hospital
Gainesville, Florida
Mayo Clinic Florida
Jacksonville, Florida