Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Rebecca Olin, MD
Headshot of Rebecca Olin
Rebecca Olin

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 Venetoclax AZD5991 Pevonedistat 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) 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 Group 1) Decitabine (BAML-16-001-S8 Group 1) AZD5153 (BAML-16-001-S10) Venetoclax (BAML-16-001-S10) TP-0903 (BAML-16-001-S14) Decitabine (BAML-16-001-S14) Decitabine (BAML-16-001-S8 Group 2) Venetoclax (BAML-16-001-S8 Group 2) AZD5991 (BAML-16-001-S18) Azacitidine (BAML-16-001-S18) SNDX-5613 (BAML-16-001-S17) Azacitidine (BAML-16-001-S17) Venetoclax (BAML-16-001-S17) BAML-16-001-S1 (Closed) BAML-16-001-S2 BAML-16-001-S3 BAML-16-001-S4 (Closed) BAML-16-001-S5 (Closed) BAML-16-001-S6 BAML-16-001-S9 (Closed) BAML-16-001-S16 (Closed) BAML-16-001-S8 BAML-16-001-S10 (Closed) BAML-16-001-S14 BAML-16-001-S18 (Closed) BAML-16-001-S17

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 or B is allowed by the sub-study where age 18 and older is allowed. 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 Master Protocol and not considered screen fails.
  • Subjects 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. Subjects with blasts % in bone marrow of 10% to 19% or blasts in blood of 10% to 19% will be allowed to enroll to this group. For previously untreated subjects with ≥ 20% blasts in bone marrow or blood only: 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. For select genomic aberrations specified in the studies, patients ≥ 18 years of age may be allowed to enroll in this portion of the study.

You CAN'T join if...

  • Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML or involved with 10% to 19% blasts 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

Lead Scientist at UCSF

  • Rebecca Olin, MD
    Professor, Medicine, School of Medicine. Authored (or co-authored) 79 research publications. Research interests: acute myeloid leukemia (AML) · acute lymphoblastic leukemia (ALL) · acute promyelocytic leukemia (APL) · myelodysplastic syndrome (MDS) · hematopoietic stem cell transplantation · myeloproliferative neoplasms (MPN) · aplastic anemia · lymphoma · multiple myeloma

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 research study
Study Type
Interventional
Participants
Expecting 2000 study participants
Last Updated