Summary

Eligibility
for people ages 18-59 (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Brian A. Jonas (ucdavis)

Description

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.

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 Clinical Trial

Details

Keywords

Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm, Acute Myeloid Leukemia Post Cytotoxic Therapy, Acute Myeloid Leukemia, Myelodysplasia-Related, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Myeloproliferative Disorders, Myelodysplastic-Myeloproliferative Diseases, Cytarabine, Azacitidine, Venetoclax, Daunorubicin, Biospecimen Collection, Bone Marrow Aspiration, Daunorubicin Hydrochloride, Echocardiography Test, Liposome-encapsulated Daunorubicin-Cytarabine, Multigated Acquisition Scan, cytarabine, daunorubicin, cytarabine, daunorubicin, venetoclax, azacitidine, venetoclax, daunorubicin and cytarabine liposome, daunorubicin and cytarabine liposome, venetoclax

Eligibility

Locations

  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at University of California Health

  • Brian A. Jonas (ucdavis)
    Professor, MED: Int Med HMCTBMT, School of Medicine. Authored (or co-authored) 96 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT05554406
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 335 study participants
Last Updated