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Anti-metabolites

Azacitidine + Gemtuzumab for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Sucha Nand
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No known hypersensitivity to azacitidine, mannitol, hydroxyurea, or gemtuzumab ozogamicin
Bilirubin =< 2.0 x institutional upper limit of normal (IULN) unless due to hepatic infiltration by AML
Must not have
WHO acute promyelocytic leukemia (FAB M3) or blastic transformation of chronic myelogenous leukemia
History of prior MDS treatment with AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying azacitidine and gemtuzumab ozogamicin to treat older patients with previously untreated acute myeloid leukemia.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, liver problems, low blood counts leading to increased infection risk, bleeding complications, and potential harm to unborn babies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not allergic to azacitidine, mannitol, hydroxyurea, or gemtuzumab ozogamicin.
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My bilirubin levels are within twice the normal limit, not due to liver infiltration by AML.
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My liver function tests are within normal limits.
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I have been diagnosed with a specific type of leukemia, not including acute promyelocytic leukemia or blastic phase CML.
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I can take care of myself but may not be able to do heavy physical work.
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I haven't had chemotherapy for acute leukemia, except possibly hydroxyurea.
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My heart pumps well and I haven't had heart failure in the last 56 days.
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My cancer has not spread to my brain or spinal cord.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My leukemia is either acute promyelocytic or in a blastic phase of chronic myelogenous.
Select...
I've had intense chemotherapy or stem cell support for myelodysplastic syndrome.
Select...
I have been treated with azacitidine, decitabine, or gemtuzumab ozogamicin.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I have had cancer before, but it fits the exceptions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
30-Day Survival
Complete Response
Secondary study objectives
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Relapse-free Survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (azacitidine, gemtuzumab)Experimental Treatment2 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~460
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,920 Previous Clinical Trials
41,016,801 Total Patients Enrolled
Sucha NandPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00658814 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (azacitidine, gemtuzumab)
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT00658814 — Phase 2
Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00658814 — Phase 2
~8 spots leftby Nov 2025
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