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)

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 ther

Trial Details

NCT ID
NCT06917911
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Cytarabine
  • Daunorubicin Hydrochloride
  • Echocardiography Test
  • Gemtuzumab Ozogamicin
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • La Jolla, California, United States|32.84727,-117.2742
  • Pembroke Pines, Florida, United States|26.00315,-80.22394
  • Coeur d'Alene, Idaho, United States|47.67768,-116.78047
  • Post Falls, Idaho, United States|47.71796,-116.95159

Key Eligibility Criteria

  • GENERAL MYELOMATCH CRITERIA: Patients must be registered to the Master Screening and Reassessment Protocol, MYELOMATCH, and assigned to this protoc…
  • GENERAL MYELOMATCH CRITERIA: Participants must not have received prior anti-cancer therapy for AML or myelodysplastic syndrome (MDS)
  • Note: Hydroxyurea to control the white blood cell count (WBC) and cytarabine up to 1g for urgent cytoreduction is allowed.
  • Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →