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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 16, 2021

Primary Completion Date

June 5, 2023

Study Completion Date

January 30, 2026

Conditions
Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeAcute Myeloid Leukemia Post Cytotoxic TherapySecondary Acute Myeloid Leukemia
Interventions
DRUG

Azacitidine

Given IV or SC

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood specimen collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Venetoclax

Given PO

Trial Locations (29)

20007

MedStar Georgetown University Hospital, Washington D.C.

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

27012

Wake Forest University at Clemmons, Clemmons

27157

Wake Forest University Health Sciences, Winston-Salem

28659

Wake Forest Baptist Health - Wilkes Medical Center, Wilkesboro

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63136

Siteman Cancer Center at Christian Hospital, St Louis

63141

Siteman Cancer Center at West County Hospital, Creve Coeur

63376

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

64064

University of Kansas Cancer Center - Lee's Summit, Lee's Summit

64108

University Health Truman Medical Center, Kansas City

64116

University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City

64154

University of Kansas Cancer Center - North, Kansas City

66044

Lawrence Memorial Hospital, Lawrence

66061

The University of Kansas Cancer Center - Olathe, Olathe

66160

University of Kansas Cancer Center, Kansas City

66205

University of Kansas Hospital-Westwood Cancer Center, Westwood

66210

University of Kansas Cancer Center-Overland Park, Overland Park

66606

University of Kansas Health System Saint Francis Campus, Topeka

66762

Mercy Hospital Pittsburg, Pittsburg

67401

Salina Regional Health Center, Salina

67601

HaysMed, Hays

73104

University of Oklahoma Health Sciences Center, Oklahoma City

06830

Smilow Cancer Hospital Care Center at Greenwich, Greenwich

06105

Smilow Cancer Hospital Care Center at Saint Francis, Hartford

06520

Yale University, New Haven

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH