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Studies

Interventional Recruiting Phase 2

NCT05554406 on ClinicalTrials.gov

Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)

Official title: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH SubStudy

  • Sponsor: National Cancer Institute (Egypt)
  • Enrollment: 335 (Estimated)
  • Study start: 2024-09-25 (Actual)
  • Primary completion: 2027-03-31 (Estimated)
  • Study completion: 2027-03-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal 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. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.

Conditions

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
  • Acute Myeloid Leukemia Post Cytotoxic Therapy
  • Acute Myeloid Leukemia, Myelodysplasia-Related

Intervention / Treatment

  • Drug: Azacitidine
  • Procedure: Biospecimen Collection
  • Procedure: Bone Marrow Aspiration
  • Drug: Cytarabine
  • Drug: Daunorubicin Hydrochloride
  • Procedure: Echocardiography Test
  • Drug: Liposome-encapsulated Daunorubicin-Cytarabine
  • Procedure: Multigated Acquisition Scan
  • Drug: Venetoclax

Primary Outcome Measures

  • Minimal residual disease (MRD) response (Arm 1, 2, 4 and 5) (After induction (28 days) or re-induction (56 days))
    Will be analyzed using intent-to-treat (ITT) principles.
  • MRD response (Arm 3) (After two cycles of therapy (56 days))
    Will be analyzed using ITT principles.

Countries

Canada, Puerto Rico, United States

Locations and Investigators

  • University of Alabama at Birmingham Cancer Center, Birmingham, United States (Recruiting)
    • Site Public Contact
    • Razan Mohty (Principal Investigator)
  • Mayo Clinic Hospital in Arizona, Phoenix, United States (Recruiting)
    • Site Public Contact
    • Antoine Saliba (Principal Investigator)
  • Banner University Medical Center - Tucson, Tucson, United States (Recruiting)
    • Site Public Contact
    • Sharad Khurana (Principal Investigator)
  • University of Arizona Cancer Center-North Campus, Tucson, United States (Recruiting)
    • Site Public Contact
    • Sharad Khurana (Principal Investigator)
  • University of Arkansas for Medical Sciences, Little Rock, United States (Recruiting)
    • Site Public Contact
    • Ankur Varma (Principal Investigator)
  • Alta Bates Summit Medical Center-Herrick Campus, Berkeley, United States (Active not recruiting)
  • Cedars-Sinai Medical Center, Los Angeles, United States (Recruiting)
    • Site Public Contact
    • Noah M. Merin (Principal Investigator)
  • Kaiser Permanente-Oakland, Oakland, United States (Recruiting)
    • Site Public Contact
    • Faisal N. Cheema (Principal Investigator)
  • Kaiser Permanente-Roseville, Roseville, United States (Recruiting)
    • Site Public Contact
    • Faisal N. Cheema (Principal Investigator)
  • University of California Davis Comprehensive Cancer Center, Sacramento, United States (Recruiting)
    • Site Public Contact
    • Brian A. Jonas (Principal Investigator)
  • UCSF Medical Center-Parnassus, San Francisco, United States (Recruiting)
    • Site Public Contact
    • Timothy Ferng (Principal Investigator)
  • Mills Health Center, San Mateo, United States (Active not recruiting)
  • Kaiser Permanente Medical Center - Santa Clara, Santa Clara, United States (Recruiting)
    • Site Public Contact
    • Faisal N. Cheema (Principal Investigator)
  • Yale University, New Haven, United States (Recruiting)
    • Site Public Contact
    • Jan P. Bewersdorf (Principal Investigator)
  • Mayo Clinic in Florida, Jacksonville, United States (Recruiting)
    • Site Public Contact
    • Antoine Saliba (Principal Investigator)
  • Miami Cancer Institute, Miami, United States (Recruiting)
    • Site Public Contact
    • Firas El Chaer (Principal Investigator)
  • Memorial Hospital West, Pembroke Pines, United States (Recruiting)
    • Site Public Contact
    • Jonathan Feld (Principal Investigator)
  • Phoebe Putney Memorial Hospital, Albany, United States (Recruiting)
    • Site Public Contact
    • Vamsi Kota (Principal Investigator)
  • Augusta University Medical Center, Augusta, United States (Recruiting)
    • Site Public Contact
    • Vamsi Kota (Principal Investigator)
  • Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, United States (Recruiting)
    • Site Public Contact
    • Craig S. Boddy (Principal Investigator)
  • Straub Clinic and Hospital, Honolulu, United States (Recruiting)
    • Site Public Contact
    • Craig S. Boddy (Principal Investigator)
  • Kapiolani Medical Center for Women and Children, Honolulu, United States (Recruiting)
    • Site Public Contact
    • Craig S. Boddy (Principal Investigator)
  • Hawaii Cancer Care - Westridge, ‘Aiea, United States (Recruiting)
    • Site Public Contact
    • Craig S. Boddy (Principal Investigator)
  • Pali Momi Medical Center, ‘Aiea, United States (Recruiting)
    • Site Public Contact
    • Craig S. Boddy (Principal Investigator)
  • Saint Alphonsus Cancer Care Center-Boise, Boise, United States (Recruiting)
    • Site Public Contact
    • Tareq Al baghdadi (Principal Investigator)
  • Saint Luke's Cancer Institute - Boise, Boise, United States (Recruiting)
    • Site Public Contact
    • Charles W. Drescher (Principal Investigator)
  • Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, United States (Recruiting)
    • Site Public Contact
    • Tareq Al baghdadi (Principal Investigator)
  • Kootenai Health - Coeur d'Alene, Coeur d'Alene, United States (Recruiting)
    • Site Public Contact
    • John M. Schallenkamp (Principal Investigator)
  • Saint Luke's Cancer Institute - Fruitland, Fruitland, United States (Recruiting)
    • Site Public Contact
    • Charles W. Drescher (Principal Investigator)
  • Saint Luke's Cancer Institute - Meridian, Meridian, United States (Recruiting)
    • Site Public Contact
    • Charles W. Drescher (Principal Investigator)
  • Saint Alphonsus Cancer Care Center-Nampa, Nampa, United States (Recruiting)
    • Site Public Contact
    • Tareq Al baghdadi (Principal Investigator)
  • Saint Luke's Cancer Institute - Nampa, Nampa, United States (Recruiting)
    • Site Public Contact
    • Charles W. Drescher (Principal Investigator)
  • Kootenai Clinic Cancer Services - Post Falls, Post Falls, United States (Recruiting)
    • Site Public Contact
    • John M. Schallenkamp (Principal Investigator)
  • Kootenai Clinic Cancer Services - Sandpoint, Sandpoint, United States (Recruiting)
    • Site Public Contact
    • John M. Schallenkamp (Principal Investigator)
  • OSF Saint Joseph Medical Center, Bloomington, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • Illinois CancerCare-Bloomington, Bloomington, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • Illinois CancerCare-Canton, Canton, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • Illinois CancerCare-Carthage, Carthage, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • Northwestern University, Chicago, United States (Recruiting)
    • Site Public Contact
    • Jessica K. Altman (Principal Investigator)
  • University of Chicago Comprehensive Cancer Center, Chicago, United States (Recruiting)
    • Site Public Contact
    • Olatoyosi M. Odenike (Principal Investigator)
  • Cancer Care Specialists of Illinois - Decatur, Decatur, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • Decatur Memorial Hospital, Decatur, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • Illinois CancerCare-Dixon, Dixon, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • Crossroads Cancer Center, Effingham, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • Illinois CancerCare-Eureka, Eureka, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • NorthShore University HealthSystem-Evanston Hospital, Evanston, United States (Recruiting)
    • Site Public Contact
    • David L. Grinblatt (Principal Investigator)
  • Illinois CancerCare-Galesburg, Galesburg, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)
  • NorthShore University HealthSystem-Glenbrook Hospital, Glenview, United States (Recruiting)
    • Site Public Contact
    • David L. Grinblatt (Principal Investigator)
  • NorthShore University HealthSystem-Highland Park Hospital, Highland Park, United States (Recruiting)
    • Site Public Contact
    • David L. Grinblatt (Principal Investigator)
  • Illinois CancerCare-Kewanee Clinic, Kewanee, United States (Recruiting)
    • Site Public Contact
    • Bryan A. Faller (Principal Investigator)

And 177 other sites.

Study Officials

  • Paul J Shami (Principal Investigator) — SWOG Cancer Research Network