Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Trial Status: Active
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.
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 or B is allowed by the sub-study where age 18 and older is allowed.
- 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.
Exclusion Criteria
- 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
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Vlad Kustanovich
Phone: 310-206-5755
Email:
VKustanovich@mednet.ucla.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email:
cancertrials@ucsf.edu
Colorado
Aurora
University of Colorado Hospital
Status: COMPLETED
Contact: Daniel A. Pollyea
Email:
DANIEL.POLLYEA@UCDENVER.EDU
Florida
Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Georgia
Atlanta
Emory University Hospital / Winship Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Kansas
Fairway
University of Kansas Clinical Research Center
Status: ACTIVE
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Maryland
Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Minnesota
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
New York
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Oregon
Portland
OHSU Knight Cancer Institute
Status: ACTIVE
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Texas
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Utah
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Karen Pena
Phone: 801-213-4233
Email:
karen.pena@hci.utah.edu
Trial Phase Phase I/II
Trial Type Treatment
Lead Organization
Beat AML, LLC
- Primary ID BAML-16-001
- Secondary IDs NCI-2017-00278
- Clinicaltrials.gov ID NCT03013998