Study of Biomarker-Based Treatment of Acute Myeloid Leukemia



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:60 - Any
Updated:2/17/2019
Start Date:November 2016
End Date:December 2021
Contact:Spencer Kalk
Email:spencer.kalk@incresearch.com
Phone:919-227-5843

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

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

- 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.)

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
We found this trial at
14
sites
Dallas, Texas 75390
Principal Investigator: Prapti Patel, MD
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: William Blum, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Wendy Stock, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Uma Borate, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Maria Baer, MD
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: John C Byrd, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Denver, Colorado 80210
Principal Investigator: Dan Pollyea, MD
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Denver, CO
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: James Foran, MD
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Los Angeles, California 90024
Principal Investigator: Gary Schiller, MD
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Los Angeles, CA
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Eytan M Stein, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Phoenix, Arizona 85054
Principal Investigator: Lisa Sproat, MD
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Rochester, Minnesota 55905
Principal Investigator: Mark R Litzow, MD
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Rochester, MN
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Michael Deininger, MD, PhD
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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San Francisco, California 94143
Principal Investigator: Rebecca Olin, MD
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San Francisco, CA
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