Venetoclax or GO added to standard chemotherapy for CBF-AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase II MYELOMATCH trial, patients with CBF-AML receive the standard 7+3 chemotherapy regimen plus either venetoclax or gemtuzumab ozogamicin. The study compares complete remission without measurable residual disease after induction between the two arms and looks at survival, relapse, death, and early mortality, along with safety. It also explores biomarkers and MRD assessment methods to understand predictive signals and the clinical impact of certain mutations. The trial uses biospecimen collection and standard supportive procedures, with enrollment through the MYELOMATCH framework. Locations include sites in Alabama, California, and Florida, funded by the NCI under the MYELOMATCH program.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* GENERAL MYELOMATCH CRITERIA: Patients must be registered to the Master Screening and Reassessment Protocol, MYELOMATCH, and assigned to this protocol by the MATCHBox Treatment Verification Team
* 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
* GENERAL MYELOMATCH CRITERIA: Participants must not receive any cytarabine-containing therapy other than up to 1g of cytarabine, which is allowed for urgent cytoreduction. Hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed
* Diagnosis of AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1 or AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22)/CBFB::MYH11. No FLT3 mutation (these patients should be considered for a FLT3-focused MYELOMATCH study)
* Secondary CBF-AML (e.g., prior pre-leukemic hematologic malignancy or history of chemotherapy/radiation therapy) is allowed.
* No prior AML or MDS-directed therapy except for urgent treatment of leukocytosis with leukapheresis, cytarabine, and hydroxyurea, Prior intrathecal chemotherapy for central nervous system (CNS) involvement of AML is permitted
* Age 18-59 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless patient has a history of Gilbert syndrome and direct bilirubin is ≤ 1.5 x ULN)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x upper limit of normal (ULN)
* Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73m\^2
* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Participants with CNS disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease
* Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
* No known medical condition causing an inability to swallow oral formulations of agents

Where it's running

• University of Alabama at Birmingham Cancer Center
  Birmingham, Alabama, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Memorial Hospital West
  Pembroke Pines, Florida, United States Recruiting
• Kootenai Health - Coeur d'Alene
  Coeur d'Alene, Idaho, United States Recruiting
• Kootenai Clinic Cancer Services - Post Falls
  Post Falls, Idaho, United States Recruiting
• Kootenai Clinic Cancer Services - Sandpoint
  Sandpoint, Idaho, United States Recruiting

+31 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Celalettin Ustun — Alliance for Clinical Trials in Oncology

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.