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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
Azacitidine
2012
Completed Phase 3
~1440
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,513 Total Patients Enrolled
Sucha NandPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00658814 — Phase 2
Acute Myelomonocytic Leukemia Research Study Groups: Treatment (azacitidine, gemtuzumab)
Acute Myelomonocytic 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for participants of this clinical trial?

"At the present time, this experiment is not recruiting participants. It was originally posted on December 1st 2008 and then edited most recently in October 15th 2022. For those considering other trials, there are currently 1534 studies actively seeking patients with leukemia, myelomonocytic acute and 197 clinical trials using Azacitidine that are accepting applications."

Answered by AI

How many participants are engaged in this research endeavor?

"This clinical trial has ceased its recruitment process. The initial posting was on December 1st 2008 and the last update occured October 15th 2022. If you are search for other trials, there is a list of 1534 studies recruiting patients with leukemia or myelomonocytic acute leukaemia, as well as 197 studies actively seeking participants to use Azacitidine."

Answered by AI

What medical applications commonly employ Azacitidine?

"Azacitidine is a preferred choice for induction chemotherapy. It can also provide relief from refractory anemias, leukemia, myelocytic and acute multilineage dysplasia."

Answered by AI

What other explorations have been undertaken to explore the potential of Azacitidine?

"Azacitidine's first clinical trials were conducted in 2006 at the Chinese University of Hong Kong-Prince of Wales Hospital. As of now, a total 184 studies have been concluded and 197 are still ongoing - with many taking place within Livonia, Michigan."

Answered by AI

Has the Federal Drug Administration sanctioned Azacitidine?

"The safety of Azacitidine is assigned a rating of 2 since it has only undergone Phase 2 trials, demonstrating some degree of security but no efficacy data."

Answered by AI

How many centers are currently administering this study?

"This medical study has 100 participants, including those from Saint Mary Mercy Hospital in Livonia, Lake Huron Medical Center in Port Huron and Research Medical Center in Kansas City."

Answered by AI
~8 spots leftby Mar 2025