Azacitidine + Gemtuzumab for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+203 other locations

Overseen by Sucha Nand

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.

Research Team

Sucha Nand

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for older patients with untreated acute myeloid leukemia (AML) who haven't had prior AML chemotherapy, except hydroxyurea. They should not be allergic to the study drugs or have a history of certain other cancers within the last 2 years. HIV+ patients can join if they meet specific criteria. Participants must have functioning major organs and no central nervous system involvement by cancer.

Inclusion Criteria

I am not allergic to azacitidine, mannitol, hydroxyurea, or gemtuzumab ozogamicin.

Consent to submit specimens to SWOG repository

Complete remission (CR) or CRi documented within 42 days before registration

Exclusion Criteria

My leukemia is either acute promyelocytic or in a blastic phase of chronic myelogenous.

I've had intense chemotherapy or stem cell support for myelodysplastic syndrome.

I have been treated with azacitidine, decitabine, or gemtuzumab ozogamicin.

Treatment Details

Interventions

• Azacitidine (Anti-metabolites)
• Gemtuzumab Ozogamicin (Anti-tumor antibiotic)

Trial Overview The trial tests azacitidine and gemtuzumab ozogamicin's effectiveness in treating AML when given together. Azacitidine interferes with cell growth enzymes, while gemtuzumab ozogamicin is an antibody that targets and kills cancer cells or delivers toxins to them.

Participant Groups

Group I: Treatment (azacitidine, gemtuzumab) Experimental Treatment 2 Interventions

See Detailed Description

Azacitidine is already approved in Canada, Japan for the following indications:

Approved in Canada as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School