NCT04214249View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 17, 2021

Primary Completion Date

November 27, 2024

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
PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cytarabine

Given via continuous IV infusion

DRUG

Daunorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Hematopoietic Cell Transplantation

Undergo HSCT

DRUG

Idarubicin Hydrochloride

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Punch Biopsy

Undergo a skin punch biopsy

Trial Locations (10)

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

27012

Wake Forest University at Clemmons, Clemmons

27157

Wake Forest University Health Sciences, Winston-Salem

28659

Wake Forest Baptist Health - Wilkes Medical Center, Wilkesboro

35233

University of Alabama at Birmingham Cancer Center, Birmingham

60611

Northwestern University, Chicago

92868

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

06520

Yale University, New Haven

32224-9980

Mayo Clinic in Florida, Jacksonville

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH