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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04214249
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Acute Myeloid Leukemia Post Cytotoxic Therapy
  • Secondary Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Cytarabine — DRUG
    Given via continuous IV infusion
  • Daunorubicin Hydrochloride — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Hematopoietic Cell Transplantation — PROCEDURE
    Undergo HSCT
  • Idarubicin Hydrochloride — DRUG
    Given IV
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Punch Biopsy — PROCEDURE
    Undergo a skin punch biopsy

Study Details

This phase II trial studies how well cytarabine and idarubicin or daunorubicin with or without pembrolizumab work in treating patients with newly-diagnosed acute myeloid leukemia. Chemotherapy drugs, such as cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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 induction chemotherapy with pembrolizumab may work better than induction chemotherapy alone in treating patients with acute myeloid leukemia.

Key Dates

Start date
Feb 17, 2021
Status verified
Dec 2025
Primary completion
Nov 27, 2024
Completion
Jan 30, 2027

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (cytarabine, idarubicin,daunorubicin,pembrolizumab,HSCT)
    See Detailed Description.
  • Active Comparator: Arm II (cytarabine, idarubicin, daunorubicin, HSCT)
    See Detailed Description.

Primary Outcome Measure

Rate of Minimal Residual Disease (MRD) Negative - Complete Response (CR)/Complete Remission With Incomplete Recovery (CRi) [ Time Frame: 78 days (mean) ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Yale UniversityNew HavenConnecticut06520-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Northwestern UniversityChicagoIllinois60611-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
Wake Forest University at ClemmonsClemmonsNorth Carolina27012-
Wake Forest Baptist Health - Wilkes Medical CenterWilkesboroNorth Carolina28659-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAYale University· New Haven, CTMayo Clinic in Florida· Jacksonville, FLNorthwestern University· Chicago, ILDartmouth Hitchcock Medical Center/Dartmouth Cancer Center· Lebanon, NH

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