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NCT04284787 · ClinicalTrials.gov registry record · Phase 2
BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit 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
- 60
- Enrollment target
- 20
- Study locations
NCT04284787: Active Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
NCT04284787 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 60 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04284787, 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
- 60 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well azacitidine and venetoclax with or without pembrolizumab work in treating older patients with newly diagnosed acute myeloid leukemia. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. 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 azacitidine and venetoclax with pembrolizumab may increase the rate of deeper/better responses and reduce the chance of the leukemia coming back in patients with newly diagnosed acute myeloid leukemia compared to conventional therapy of azacitidine and venetoclax alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Biopsy Procedure
- DRUG Azacitidine
Study Locations (20)
Kansas
- HaysMed - Hays
- University of Kansas Cancer Center - Kansas City
- Lawrence Memorial Hospital - Lawrence
- The University of Kansas Cancer Center - Olathe - Olathe
- University of Kansas Cancer Center-Overland Park - Overland Park
- Mercy Hospital Pittsburg - Pittsburg
- Salina Regional Health Center - Salina
- University of Kansas Health System Saint Francis Campus - Topeka
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- University Health Truman Medical Center - Kansas City
- University of Kansas Cancer Center - North - Kansas City
- University of Kansas Cancer Center - Lee's Summit - Lee's Summit
Connecticut
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Yale University - New Haven
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Illinois
- Northwestern University - Chicago
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 2 |
What the registry record for NCT04284787 still lists
NCT04284787 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower).
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.
NCT04284787 names 20 study sites across 6 states, led by Kansas, Missouri, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04284787 about?
NCT04284787 is a clinical study titled "BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia". This phase II trial studies how well azacitidine and venetoclax with or without pembrolizumab work in treating older patients with newly diagnosed acute myeloid leukemia. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells, b...
What is the current status of trial NCT04284787?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-02-16. Estimated completion is 2027-01-30.
What conditions does trial NCT04284787 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 NCT04284787?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Biopsy Procedure (PROCEDURE), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT04284787?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04284787 being conducted?
This trial has 20 study locations across Connecticut, District of Columbia, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04284787's enrollment target sits among peer trials
60 120th of 306 higher than 180 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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