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NCT04214249 · ClinicalTrials.gov registry record · Phase 2
BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 10
- Study locations
NCT04214249 is a Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 49 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (58% lower). The trial reports 10 study locations across 8 states.
The verdict
NCT04214249, a Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 10
- Study locations
Study Summary
This phase II trial studies how well cytarabine and idarubicin or daunorubicin with or without pembrolizumab work in treating patients with newly-diagnosed acute myeloid leukemia. Chemotherapy drugs, such as cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving induction chemotherapy with pembrolizumab may work better than induction chemotherapy alone in treating patients with acute myeloid leukemia.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- DRUG Cytarabine
Study Locations (10)
North Carolina
- Wake Forest University at Clemmons - Clemmons
- Wake Forest Baptist Health - Wilkes Medical Center - Wilkesboro
- Wake Forest University Health Sciences - Winston-Salem
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
California
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Connecticut
- Yale University - New Haven
Florida
- Mayo Clinic in Florida - Jacksonville
Illinois
- Northwestern University - Chicago
New Hampshire
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center - Lebanon
Virginia
- Virginia Commonwealth University/Massey Cancer Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-02-17 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04214249
The ClinicalTrials.gov registry entry for NCT04214249 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (58% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04214249 reports 10 study locations spanning 8 distinct geographic areas - top geographies include North Carolina, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT04214249 about?
NCT04214249 is a clinical study titled "BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia". This phase II trial studies how well cytarabine and idarubicin or daunorubicin with or without pembrolizumab work in treating patients with newly-diagnosed acute myeloid leukemia. Chemotherapy drugs, such as cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cance...
What is the current status of trial NCT04214249?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2021-02-17. Estimated completion is 2027-01-30.
What conditions does trial NCT04214249 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Secondary Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy.
What interventions are being tested in trial NCT04214249?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT04214249?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04214249 being conducted?
This trial has 10 study locations across Alabama, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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