Georgia's Online Cancer Information Center

Find A Clinical Trial

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

Status
Closed
Cancer Type
Leukemia
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04778397
Protocol IDs
GS-US-546-5857 (primary)
NCI-2021-03967
2020-003949-11
Study Sponsor
Gilead

Summary

The goal of this clinical study is to compare the effectiveness of the study drugs,
magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine
in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

Eligibility

  1. Individuals with confirmation of acute myeloid leukemia (AML) by World Health Organization criteria, previously untreated for AML, and who have presence of at least 1 TP53 gene mutation that is not benign or likely benign based on evaluation by either central laboratory or an approved local laboratory (after central review of the bone marrow TP53 mitigation next-generation sequencing test results) (individuals with biallelic 17p deletions, loss of both 17p alleles, are eligible based on locally evaluated cytogenetics/karyotype/fluorescence in situ hybridization (FISH) report).
  2. Individuals with white blood cell (WBC) count = 20×10^3/microliter (µL) prior to randomization. If the individual's WBC is > 20×10^3/µL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be = 20×10^3/µL prior to the first dose of study treatment and prior to each magrolimab dose the first 4 weeks (if the individual is randomized to the experimental arm) Note: Individuals can be treated with hydroxyurea and/or leukapheresis throughout the study or prior to randomization to reduce the WBC to = 20×10^3/µL to enable eligibility for study drug dosing.
  3. The hemoglobin must be = 9 grams per deciliter (g/dL) prior to initial dose of study treatment. Notes: Transfusions are allowed to meet hemoglobin eligibility.
  4. Individual has provided informed consent.
  5. Individual is willing and able to comply with clinic visits and procedure outlined in the study protocol.
  6. Individuals must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, except for individuals less than 75 years of age and appropriate for non-intensive treatment. For these individuals, the ECOG performance status score may be 0 to 3.
  7. Individuals must have adequate renal function as demonstrated by a creatinine clearance = 30 milliliters per minute calculated by the Cockcroft Gault formula.
  8. Adequate cardiac function as demonstrated by:
  9. Lack of symptomatic congestive heart failure and clinically significant cardiac arrhythmias and ischemic heart disease.
  10. Left ventricular ejection fraction (LVEF) > 50% for individuals appropriate for intensive therapy.
  11. Adequate liver function as demonstrated by:
  12. Aspartate aminotransferase = 3.0 × upper limit of normal (ULN).
  13. Alanine aminotransferase = 3.0 × ULN.
  14. Total bilirubin = 1.5 × ULN, or primary unconjugated bilirubin = 3.0 × ULN if individual has a documented history of Gilbert's syndrome or genetic equivalent.
  15. Pretreatment blood cross-match completed.
  16. Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  17. Individuals must be willing to consent to mandatory pretreatment and on-treatment bone marrow biopsies (aspirate and trephines).
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.