Clinical trialNCT04284787Active, not recruitingPhase 2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment60Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeAcute Myeloid Leukemia Post Cytotoxic TherapySecondary Acute Myeloid Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Amer M Zeidan
Yale University Cancer Center LAO
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

29 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Haysmed
Hays, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
the University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Mercy Hospital Pittsburg
Pittsburg, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Johns Hopkins University/sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee'S Summit
Lee's Summit, Missouri, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center/dartmouth Cancer Center
Lebanon, New Hampshire, United States
Wake Forest University at Clemmons
Clemmons, North Carolina, United States
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Azacitidine →Pembrolizumab →Venetoclax →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 16 Feb 2021
Primary completion: 5 Jun 2023
Completion: 30 Jan 2027
Last update posted: 3 Aug 2026
Registered enrollment: 60
Registry id: NCT04284787

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.