Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

This screening and multi-sub-study Phase 1b/2/3 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 marker negative sub-studies which will include all screened patients not eligible for any of the biomarker-driven

Trial Details

NCT ID
NCT03013998
Phase
PHASE2 / PHASE3
Sponsor
Beat AML, LLC
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Samalizumab (BAML-16-001-S1)
  • BI 836858 (BAML-16-001-S2)
  • Laboratory Biomarker Analysis
  • Daunorubicin (BAML-16-001-S1)
  • Cytarabine (BAML-16-001-S1)
  • Azacitidine (BAML-16-001-S2)
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Francisco, California, United States|37.77493,-122.41942
  • Denver, Colorado, United States|39.73915,-104.9847

Key Eligibility Criteria

  • Adults, age ≥60 yrs at diagnosis unless in a specific known cytogenetic \& genomic group for which treatment in Group A, B, or C is allowed by the …
  • Patients must be able to understand \& provide written informed consent
  • Group A: Patients must have previously untreated AML according to WHO classification w/ no prior treatment other than hydroxyurea. Patients w/ myel…
  • Group B: Patients must have relapsed or refractory AML according to WHO classification. For study purposes, refractory AML is defined as failure to…

For full eligibility, visit ClinicalTrials.gov.

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