Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT03013998. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This screening and multi-sub-study Phase 1b/2/3 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 marker negative sub-studies 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.
Study identification
- NCT ID
- NCT03013998
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 3,000 participants
Conditions and interventions
Interventions
- Samalizumab (BAML-16-001-S1) Biological
- BI 836858 (BAML-16-001-S2) Biological
- Laboratory Biomarker Analysis Other
- 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
- Bleximenib (BAML-16-001-S25/HO181) Drug
- Cytarabine (BAML-16-001-S25/HO181) Drug
- Daunorubicin or Idarubicin (BAML-16-001-S25/HO181) Drug
- Placebo (BAML-16-001-S25/HO181) Drug
- Revumenib (BAML-16-001-S26/HO177) Drug
- Placebo (BAML-16-001-S26/HO177) Drug
Biological · Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2016
- Primary completion
- Nov 30, 2032
- Completion
- Nov 30, 2032
- Last update posted
- Sep 2, 2026
2016 – 2032
United States locations
- U.S. sites
- 31
- U.S. states
- 21
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | Completed |
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | Not yet recruiting |
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | Recruiting |
| University of California, San Francisco | San Francisco | California | 94143 | Recruiting |
| University of Colorado | Denver | Colorado | 80203 | Completed |
| University of Florida Health Shands Cancer Hospital | Gainesville | Florida | 32608 | Completed |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Not yet recruiting |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | Not yet recruiting |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | Recruiting |
| Georgia Cancer Center | Augusta | Georgia | 30912 | Not yet recruiting |
| Rush University Medical Center | Chicago | Illinois | 60612 | Not yet recruiting |
| University of Chicago | Chicago | Illinois | 60637 | Recruiting |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | Recruiting |
| Pikeville Medical Center | Pikeville | Kentucky | 41501 | Not yet recruiting |
| University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | Recruiting |
| Massachusetts General Hospital- Boston | Boston | Massachusetts | 02114 | Not yet recruiting |
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | Not yet recruiting |
| St. Louis University | St Louis | Missouri | 63110 | Not yet recruiting |
| Washington University in St. Louis | St Louis | Missouri | 63130 | Not yet recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| Univerisy of Rochester | Rochester | New York | 14611-3847 | Not yet recruiting |
| UNC Hospitals, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | Recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | Recruiting |
| Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| Oregon Health & Science University | Portland | Oregon | 97239 | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Not yet recruiting |
| Brown University Health | Providence | Rhode Island | 02906 | Not yet recruiting |
| University of Texas Southwest Medical | Dallas | Texas | 75390 | Recruiting |
| MD Anderson | Houston | Texas | 77030 | Not yet recruiting |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | Completed |
| WVU Health Sciences Center | Morgantown | West Virginia | 26506 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03013998, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03013998 live on ClinicalTrials.gov.