Trial details
Myelomatch, Master Screening and Reassessment Protocol (MSRP) for Tier Advancement in the NCI Myelomatch Clinical Trials (ALC.7 Myelomatch)
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: ALC.7 Myelomatch
Official title: Myelomatch, Master Screening and Reassessment Protocol (MSRP) for Tier Advancement in the NCI Myelomatch Clinical Trials (ALC.7 Myelomatch)
Principal Investigator: Dr. Rena Buckstein
Cancer type: Blood Related
Cancer location: Leukemia
Disease stage: Advanced Cancer
Trial phase: Phase 2
Intervention: Drug: Azacitidine Procedure: Biospecimen Collection Procedure: Bone Marrow Aspiration Drug: Cytarabine Drug: Daunorubicin Hydrochloride Drug: Venetoclax
Registration #:
NCT05554393 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. 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. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.
Disease Related Criteria: - suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS. Prior/Concurrent Therapy Criteria: - Participants must not have received prior anti-cancer therapy for AML or MDS. o Hydroxyurea to control the white blood cell count (WBC) is allowed o Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility o Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m2 of cytarabine, which is allowed for urgent cytoreduction - Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure. Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment.
