Summary

for people ages 60 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Keywords

Previously Untreated Acute Myeloid Leukemia Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Cytarabine Azacitidine Decitabine Daunorubicin 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) AG-221 (BAML-16-001-S3) Azacitidine (BAML-16-001-S3) Entospletinib (BAML-16-001-S4) Azacitidine (BAML-16-001-S4) Entospletinib (BAML-16-001-S5) Decitabine (BAML-16-001-S5) Entospletinib (BAML-16-001-S6) Azacitidine (BAML-16-001-S6) Daunorubicin (BAML-16-001-S6) Cytarabine (BAML-16-001-S6) Pevonedistat (BAML-16-001-S9) Azacitidine (BAML-16-001-S9) AG-120 (BAML-16-001-S16) Azacitidine (BAML-16-001-S16) Gilteritinib (BAML-16-001-S8) Decitabine (BAML-16-001-S8) BAML-16-001-S1 BAML-16-001-S2 BAML-16-001-S3 BAML-16-001-S4 BAML-16-001-S5 BAML-16-001-S6 BAML-16-001-S9 BAML-16-001-S16 BAML-16-001-S8

Eligibility

You can join if…

Open to people ages 60 years and up

  • Adults, age 60 years or older at the time of diagnosis
  • Subjects or their legal representative must be able to understand and provide written informed consent
  • Cohort Inclusion Criteria - Group A: Subjects must have previously untreated acute myeloid leukemia (AML) according to the WHO classification with no prior treatment other than hydroxyurea. Prior therapy for myelodysplastic syndrome (MDS),myeloproliferative syndromes (MPD), or aplastic anemia is permitted but not with hypomethylating agents.
  • Cohort Inclusion Criteria - Group B: Subjects must have relapsed or refractory AML according to the WHO classification. For study purposes, refractory AML is defined as failure to ever achieve CR or recurrence of AML within 6 months of achieving CR;relapsed AML is defined as all others with disease after prior remission. (Group B is not currently recruiting.)

You CAN'T join if...

  • Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML to enter the study)
  • Acute promyelocytic leukemia
  • Symptomatic central nervous system (CNS) involvement by AML
  • Signs of leukostasis requiring urgent therapy
  • Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
  • Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up
  • Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the trial

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • UCLA Ronald Reagan Medical Center accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Beat AML, LLC
Links
more information about this study: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
ID
NCT03013998
Phase
Phase 1/2
Study Type
Interventional
Last Updated