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
Public ClinicalTrials.gov record NCT04284787. 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
BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2 (BLAST MRD AML-2): A Randomized Phase 2 Study of the Venetoclax, Azacitadine, and Pembrolizumab (VAP) Versus Venetoclax and Azacitadine as First Line Therapy in Older Patients With Acute Myeloid Leukemia (AML) Who Are Ineligible or Who Refuse Intensive Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04284787
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- Azacitidine Drug
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Bone Marrow Aspiration Procedure
- Bone Marrow Biopsy Procedure
- Echocardiography Test Procedure
- Multigated Acquisition Scan Procedure
- Pembrolizumab Biological
- Venetoclax Drug
Drug · Procedure · Biological
Eligibility (public fields only)
- Age range
- 60 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
- Feb 16, 2021 (Actual)
- Primary completion
- Jun 5, 2023 (Actual)
- Completion
- Jan 30, 2027 (Estimated)
- Last update posted
- Aug 3, 2026
2021 – 2027
United States locations
- U.S. sites
- 29
- U.S. states
- 9
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Smilow Cancer Hospital Care Center at Greenwich | Greenwich | Connecticut | 06830 | — |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| HaysMed | Hays | Kansas | 67601 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| The University of Kansas Cancer Center - Olathe | Olathe | Kansas | 66061 | — |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | — |
| Mercy Hospital Pittsburg | Pittsburg | Kansas | 66762 | — |
| Salina Regional Health Center | Salina | Kansas | 67401 | — |
| University of Kansas Health System Saint Francis Campus | Topeka | Kansas | 66606 | — |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| University Health Truman Medical Center | Kansas City | Missouri | 64108 | — |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | — |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | — |
| University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | 64116 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | — |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | — |
| Wake Forest University at Clemmons | Clemmons | North Carolina | 27012 | — |
| Wake Forest Baptist Health - Wilkes Medical Center | Wilkesboro | North Carolina | 28659 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
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 NCT04284787, 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 Aug 3, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04284787 live on ClinicalTrials.gov.