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NCT03013998 · ClinicalTrials.gov registry record · Phase 1
Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
A Phase 1 study of Previously Untreated Relapsed Refractory Acute Myeloid Leukemia, sponsored by Beat AML.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 3,000
- Enrollment target
- 19
- Study locations
NCT03013998 is a Phase 1 study of Previously Untreated Relapsed Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by Beat AML. The registered enrollment target is 3,000 participants. The trial reports 19 study locations across 16 states.
The verdict
NCT03013998, a Phase 1 study of Previously Untreated Relapsed Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Beat AML.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 3,000 participants
- Enrollment target
- 19
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Samalizumab (BAML-16-001-S1)
- BIOLOGICAL BI 836858 (BAML-16-001-S2)
- DRUG Daunorubicin (BAML-16-001-S1)
- DRUG Cytarabine (BAML-16-001-S1)
Study Locations (19)
California
- UCLA Ronald Reagan Medical Center - Los Angeles
- University of California, San Francisco - San Francisco
Florida
- University of Florida Health Shands Cancer Hospital - Gainesville
- Mayo Clinic Florida - Jacksonville
Ohio
- University of Cincinnati Medical Center - Cincinnati
- Ohio State University - Columbus
Arizona
- Mayo Clinic Arizona - Phoenix
Colorado
- University of Colorado - Denver
Georgia
- Emory University - Atlanta
Illinois
- University of Chicago - Chicago
Kansas
- University of Kansas Clinical Research Center - Fairway
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2016-11 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03013998
The ClinicalTrials.gov registry entry for NCT03013998 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 3,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beat AML, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Previously Untreated Relapsed Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03013998 reports 19 study locations spanning 16 distinct geographic areas - top geographies include California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT03013998 about?
NCT03013998 is a clinical study titled "Study of Biomarker-Based Treatment of Acute Myeloid Leukemia". 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...
What is the current status of trial NCT03013998?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 3,000 participants. The study started on 2016-11. Estimated completion is 2028-12.
What conditions does trial NCT03013998 study?
This clinical trial studies the following conditions: Previously Untreated Relapsed Refractory Acute Myeloid Leukemia.
What interventions are being tested in trial NCT03013998?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), 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).
Who is sponsoring clinical trial NCT03013998?
This trial is sponsored by Beat AML, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03013998 being conducted?
This trial has 19 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.