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Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 117 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 68 → 71 locations
  2. Start date changed from estimate of Feb 2, 2027 to Sep 28, 2026 Study sites: 68 to 71 Show 1 more changeShow less
    • Study sites: 68 to 71
  3. Start date changed from estimate of Feb 2, 2027 to Sep 28, 2026
  4. Study sites: 66 to 68
  5. Study sites: 64 to 66 Eligibility criteria expanded, about 21 words · Study description revised Show 2 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Study description revised
  6. Trial sites expanded: 61 → 64 locations Trial sites expanded: 56 → 61 locationsv112 Show 1 more changeShow less
    • Trial sites expanded: 56 → 61 locations
  7. Study sites: 56 to 61v111
  8. Study sites: 55 to 56v110
  9. Study sites: 54 to 55v109
  10. Study sites: 53 to 54v108
  11. Study sites: 52 to 53v107
  12. Trial sites expanded: 41 → 49 locationsv106
  13. Study sites: 49 to 51v105
  14. Study sites: 41 to 49v104
  15. Study sites: 40 to 41v103
  16. Re-verified, no change to tracked fieldsv102
  17. Study sites: 39 to 40v101
  18. Study sites: 37 to 39v100
  19. Study sites: 36 to 37 Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Cytarabine (Drug), Daunorubicin… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug)… · Eligibility criteria revised · Study description shortened, about 1 wordv99 Show 3 more changesShow less
    • Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Cytarabine (Drug), Daunorubicin… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug)…
    • Eligibility criteria revised
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  20. Trial sites expanded: 29 → 36 locationsv98
  21. Trial sites expanded: 24 → 28 locationsv97
  22. Study sites: 24 to 28v96
  23. Study sites: 23 to 24v95
  24. Trial sites expanded: 19 → 22 locationsv94
  25. Study sites: 19 to 22v93
  26. Site contacts updated at 1 of 19 sitesv92
  27. Study sites: 17 to 19v91
  28. Study sites: 16 to 17v90
  29. Study sites: 15 to 16v89
  30. Study sites: 14 to 15v88
  31. Trial sites expanded: 7 → 14 locationsv87
  32. Study sites: 6 to 7v86
  33. Recruitment opened Start date: Jun 18, 2026 to Feb 2, 2027 · Trial sites expanded: 0 → 6 locationsv85 Show 2 more changesShow less
    • Start date: Jun 18, 2026 to Feb 2, 2027
    • Trial sites expanded: 0 → 6 locations
  34. 17 versions Re-verified since Mar 19, 2026, no change to tracked fieldsv68-v84
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II MYELOMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine 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. Giving venetoclax with cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.
Trial Details
NCT Number NCT06917911
Lead Sponsor National Cancer Institute (NCI)
Conditions Core Binding Factor Acute Myeloid Leukemia
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov