RECRUITING

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

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Conditions

Previously Untreated Relapsed Refractory Acute Myeloid LeukemiaSNDX-5613ZE46-0134FiclatuzumabRevumenibLomonitinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Patients with myeloid malignancies \[e.g. myelodysplastic syndrome (MDS) or other diseases\], will be allowed to enroll to Master protocol if there is an available sub-study.

Official Title

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

Quick Facts

Study Start:2016-11
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03013998

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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, B, or C is allowed by the sub-study where age 18 and older is allowed. In such case, waiting for Foundation Medicine test results would not be required to proceed with sub-study treatment. 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 M1 Master Protocol and not considered screen fails.
  2. * Patients must be able to understand and provide written informed consent
  3. * Cohort Inclusion Criteria - Group A: Patients must have previously untreated acute myeloid leukemia (AML) according to the WHO classification with no prior treatment other than hydroxyurea. Patients with myeloid malignancies \[e.g. myelodysplastic syndrome (MDS) or other disease\], 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. For select group, patients who cannot wait or choose not to wait for results of genomic testing as specified in this protocol, will be allowed to enroll to select sub-studies that allow enrollment and treatment of all patients regardless of their genomic mutations or cytogenetics. For this group, patients will proceed to enroll to that select sub-study without waiting for results of genomic testing and genomic samples will be collected to be analyzed retrospectively after patients' enrollment.
  4. * Cohort Inclusion Criteria - Group B: Patients must have relapsed or refractory AML according to the WHO classification. For study purposes, refractory AML is defined as failure to ever achieve a complete response (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 sub-studies, patients ≥ 18 years of age may be allowed to enroll in this portion of the study. Patients with relapsed or refractory myeloid malignancies (e.g., MDS or other diseases) will be allowed to enroll to this group.
  5. * Cohort Inclusion Criteria - Group C: For select sites which are not part of the Beat AML core sites. These sites will only participate in select sub-studies. Patients in this group will enroll under the Beat AML M1 Master protocol with the intent to enroll into these select sub-studies and following screening on Beat M1 Master protocol, they will come off M1 Master protocol.
  1. * Acute promyelocytic leukemia
  2. * Clinically active central nervous system (CNS) involvement by AML. A patient may be considered eligible if CNS leukemia is showing response to treatment at study entry and should continue to receive intrathecal therapy as clinical indicated. Patients who require or are undergoing craniospinal irradiation of disease control would not be eligible for participation.
  3. * Signs of leukostasis requiring urgent therapy
  4. * Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
  5. * Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol (including failure to collect genomics samples for screening), or potentially hamper compliance with study treatment and follow-up
  6. * 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.

Contacts and Locations

Study Contact

Ashley Yocum, PhD
CONTACT
301-814-2788
ashley.yocum@BloodCancerUnited.org

Principal Investigator

John C Byrd, MD
PRINCIPAL_INVESTIGATOR
Beat AML

Study Locations (Sites)

Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095
United States
University of California, San Francisco
San Francisco, California, 94143
United States
University of Colorado
Denver, Colorado, 80203
United States
University of Florida Health Shands Cancer Hospital
Gainesville, Florida, 32608
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
Emory University
Atlanta, Georgia, 30308
United States
University of Chicago
Chicago, Illinois, 60637
United States
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Ohio State University
Columbus, Ohio, 43210
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Beat AML, LLC

  • John C Byrd, MD, PRINCIPAL_INVESTIGATOR, Beat AML

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-11
Study Completion Date2028-12

Study Record Updates

Study Start Date2016-11
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • SNDX-5613
  • ZE46-0134
  • Ficlatuzumab
  • Revumenib
  • Lomonitinib

Additional Relevant MeSH Terms

  • Previously Untreated Relapsed Refractory Acute Myeloid Leukemia