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NCT04214249

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

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
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Record History

The 50 most recent of 102 versions: 23 with changes below, 27 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 28 words Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Study completion pushed from Jan 30, 2027 to Oct 9, 2027
    • Secondary endpoints: details revised at 4 of 7 entries
    • Site details revised at 2 of 10 sites
  2. Study sites revised (10)v86
  3. Results first posted: Mar 4, 2026
    • Study completion date: Jan 30, 2026 to Jan 30, 2027
    • Secondary endpoints: 8 to 7
    v85
  4. Secondary endpoints: details revised at 5 of 8 entriesv84
  5. Primary endpoints: 3 to 2
    • Secondary endpoints: details revised at 5 of 8 entries
    v83
Show 18 earlier versionsHide 18 earlier versions
  1. Enrollment target: 48 to 49
    • Secondary endpoints revised (8)
    • Primary endpoints revised (3)
    v82
  2. Primary endpoints revised (3)
    • Secondary endpoints revised (8)
    v81
  3. Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)…v80
  4. Enrollment target: estimated 50 to confirmed 48
    • Primary completion date changed from estimate of Jul 31, 2025 to Nov 27, 2024
    • Study completion date: Jul 31, 2025 to Jan 30, 2026
    v77
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v75
  6. Site details revised at 1 of 10 sitesv73
  7. Primary and study completion dates: Jul 31, 2024 to Jul 31, 2025v71
  8. Enrollment target: 124 to 50
    • Primary endpoints revised (3)
    • Study description expanded, about 15 words
    v70
  9. Site details revised at 1 of 10 sitesv69
  10. Site details revised at 1 of 10 sitesv68
  11. Site details revised at 1 of 10 sitesv67
  12. Site details revised at 1 of 10 sitesv65
  13. Site details revised at 2 of 10 sitesv64
  14. Site details revised at 3 of 10 sitesv61
  15. Eligibility criteria shortened, about 16 words
    • Interventions: Biospecimen Collection (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure), Cytarabine (Drug), Daunorubicin… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)…
    • Secondary endpoints: 6 to 8
    • Study description shortened, about 2 words
    v57
  16. Start date: Jun 1, 2020 to Feb 17, 2021v56
  17. Site details revised at 1 of 10 sitesv54
  18. Study sites: 9 to 10v53
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Rate of Minimal Residual Disease (MRD) Negative - Complete Response (CR)/Complete Remission With Incomplete Recovery (CRi)
Timeframe: 78 days (mean)
Rate of MRD-negative CR
Timeframe: 33 days (mean)

Secondary (7)

Rate of CR/CRi
MRD Negativity
Percentage of Patients With MRD-CR Using a MRD Cutoff of 0.01%
Event-free Survival
Relapse-free Survival (RFS)
Show 2 moreShow less
Duration of Response (DOR)
Incidence of Adverse Events

Arms and interventions

Arm I (cytarabine, idarubicin,daunorubicin,pembrolizumab,HSCT)Experimental

See Detailed Description.

Arm II (cytarabine, idarubicin, daunorubicin, HSCT)Active comparator

See Detailed Description.

Procedures: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Echocardiography Test, Hematopoietic Cell Transplantation, Multigated Acquisition Scan, Punch Biopsy

Drugs: Cytarabine, Daunorubicin Hydrochloride, Idarubicin Hydrochloride

Biologicals: Pembrolizumab

Sites

10 sites in 1 country