Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (NCT03013998)
A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona โ Phoenix, Arizona
Age range: 18 Years
๐งช Interventions in This Study
- Samalizumab (BAML-16-001-S1) (BIOLOGICAL)
- BI 836858 (BAML-16-001-S2) (BIOLOGICAL)
- Daunorubicin (BAML-16-001-S1) (DRUG)
- Cytarabine (BAML-16-001-S1) (DRUG)
- Azacitidine (BAML-16-001-S2) (DRUG)
- AG-221 (BAML-16-001-S3) (DRUG)
- Azacitidine (BAML-16-001-S3) (DRUG)
- Entospletinib (BAML-16-001-S4) (DRUG)
- Azacitidine (BAML-16-001-S4) (DRUG)
- Entospletinib (BAML-16-001-S5) (DRUG)
- Decitabine (BAML-16-001-S5) (DRUG)
- Entospletinib (BAML-16-001-S6) (DRUG)
- Daunorubicin (BAML-16-001-S6) (DRUG)
- Cytarabine (BAML-16-001-S6) (DRUG)
- Pevonedistat (BAML-16-001-S9) (DRUG)
- Azacitidine (BAML-16-001-S9) (DRUG)
- AG-120 (BAML-16-001-S16) (DRUG)
- Azacitidine (BAML-16-001-S16) (DRUG)
- Gilteritinib (BAML-16-001-S8 Group 1) (DRUG)
- Decitabine (BAML-16-001-S8 Group 1) (DRUG)
- AZD5153 (BAML-16-001-S10) (DRUG)
- Venetoclax (BAML-16-001-S10) (DRUG)
- TP-0903 (BAML-16-001-S14) (DRUG)
- Decitabine (BAML-16-001-S14) (DRUG)
- Decitabine (BAML-16-001-S8 Group 2) (DRUG)
- Venetoclax (BAML-16-001-S8 Group 2) (DRUG)
- AZD5991 (BAML-16-001-S18) (DRUG)
- Azacitidine (BAML-16-001-S18) (DRUG)
- SNDX-5613 (BAML-16-001-S17) (DRUG)
- Azacitidine (BAML-16-001-S17) (DRUG)
- Venetoclax (BAML-16-001-S17) (DRUG)
- Gilteritinib (BAML-16-001-S8 Group 2) (DRUG)
- Venetoclax (BAML-16-001-S12 Arm A) (DRUG)
- Azacitidine (BAML-16-001-S12 Arm A) (DRUG)
- Venetoclax (BAML-16-001-S12 Arm B) (DRUG)
- Azacitidine (BAML-16-001-S12 Arm B) (DRUG)
- ZE46-0134 (BAML-16-001-S21 Group 1) (DRUG)
- ficlatuzumab (BAML-16-001-S24) (DRUG)
- Azacitidine (BAML-16-001-S24) (DRUG)
- Venetoclax (BAML-16-001-S24) (DRUG)
- ZE46-0134 (BAML-16-001-S21 Group 2) (DRUG)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (19 Sites)
- Mayo Clinic Arizona โ Phoenix, Arizona
- UCLA Ronald Reagan Medical Center โ Los Angeles, California
- University of California, San Francisco โ San Francisco, California
- University of Colorado โ Denver, Colorado
- University of Florida Health Shands Cancer Hospital โ Gainesville, Florida
- Mayo Clinic Florida โ Jacksonville, Florida
- Emory University โ Atlanta, Georgia
- University of Chicago โ Chicago, Illinois
- University of Kansas Clinical Research Center โ Fairway, Kansas
- University of Maryland Medical Center โ Baltimore, Maryland
- Mayo Clinic Minnesota โ Rochester, Minnesota
- Memorial Sloan Kettering Cancer Center โ New York, New York
- UNC Hospitals, University of North Carolina at Chapel Hill โ Chapel Hill, North Carolina
- University of Cincinnati Medical Center โ Cincinnati, Ohio
- Ohio State University โ Columbus, Ohio
- Oregon Health & Science University โ Portland, Oregon
- UPMC Hillman Cancer Center โ Pittsburgh, Pennsylvania
- University of Texas Southwestern โ Dallas, Texas
- Huntsman Cancer Institute, University of Utah โ Salt Lake City, Utah
๐ Contact the Study Coordinator
Phone: (301) 814-2788
Email: ashley.yocum@BloodCancerUnited.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Previously Untreated Relapsed Refractory Acute Myeloid Leukemia clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.