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NCT04284787

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

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
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Record History

The 50 most recent of 120 versions: 11 with changes below, 39 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 8 words
    • Study completion pushed from Jan 30, 2027 to Oct 9, 2027
    • Site details revised at 3 of 29 sites
  2. Study completion date: Jan 30, 2026 to Jan 30, 2027v91
  3. Interventions: Azacitidine (Drug), Biopsy (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy… to Azacitidine (Drug), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow…v89
  4. Study sites revised (29)v88
  5. Results first posted: Mar 13, 2025
    • Secondary endpoint revised
    • Primary endpoint revised
    • Study description shortened, about 14 words
    v86
Show 6 earlier versionsHide 6 earlier versions
  1. Enrollment target: estimated 76 to confirmed 60
    • Primary completion date changed from estimate of Aug 1, 2025 to Jun 5, 2023
    • Study completion date: Aug 1, 2025 to Jan 30, 2026
    v85
  2. Study description revisedv84
  3. Study sites revised (29)v83
  4. Eligibility criteria shortened, about 2 words
    • Interventions: Azacitidine (Drug), Biopsy (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy… to Azacitidine (Drug), Biopsy (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy…
    • Study description shortened, about 9 words
    v82
  5. Primary and study completion dates: Aug 1, 2024 to Aug 1, 2025v81
  6. Study sites revised (29)v77
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Patients With Minimal Residual Disease Negative Complete Remission (MRD-CR) or MRD-complete Remission With Incomplete Count Recovery (Cri) With Azacitidine (AZA) + Venetoclax (VEN) With MK-3475 (Pembrolizumab)
Timeframe: Up to 6 cycles (each cycle is 28 days)

Secondary (1)

Proportion of Patients Who Develop Severe Toxicity

Arms and interventions

Arm I (AZA, VEN)Active comparator

See Detailed Description

Arm II (AZA, VEN, pembrolizumab)Experimental

See Detailed Description

Drugs: Azacitidine, Venetoclax

Procedures: Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Echocardiography Test, Multigated Acquisition Scan

Biologicals: Pembrolizumab

Sites

29 sites in 1 country