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Anti-metabolites

Combination Chemotherapy + Monoclonal Antibody for Acute Myeloid Leukemia

Phase 3
Waitlist Available
Research Sponsored by Facet Biotech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 and over
Performance status: Karnofsky 50-100%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is comparing the effectiveness of chemotherapy with or without monoclonal antibody therapy for treating patients with refractory or relapsed acute myelogenous leukemia.

Who is the study for?
This trial is for adults over 18 with acute myelogenous leukemia that's resistant to treatment or has come back. They should not have had high doses of a drug called cytarabine, be pregnant, or have severe heart disease, other active cancers, uncontrolled infections, HIV, or significant organ dysfunction.Check my eligibility
What is being tested?
The study is testing if adding monoclonal antibody therapy to standard chemotherapy offers better results for patients with refractory or relapsed acute myelogenous leukemia. Patients are randomly assigned to receive either the combination treatment or chemotherapy alone.See study design
What are the potential side effects?
Chemotherapy can cause nausea, hair loss, fatigue and increased risk of infection. Monoclonal antibodies might add risks like allergic reactions and potential harm to normal cells alongside tumor cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can perform most of my daily activities without assistance.
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I do not have any other cancer that needs treatment.
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I do not have any serious infections that aren't controlled by medication.
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My organs are functioning well.

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

Find a Location

Who is running the clinical trial?

Facet BiotechLead Sponsor
21 Previous Clinical Trials
1,497 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,646 Total Patients Enrolled
1,508 Trials studying Leukemia
379,376 Patients Enrolled for Leukemia
Daniel Levitt, MD, PhDStudy ChairFacet Biotech
1 Previous Clinical Trials
181 Total Patients Enrolled

Media Library

Cytarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00006045 — Phase 3
Leukemia Research Study Groups:
Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT00006045 — Phase 3
Cytarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00006045 — Phase 3

Frequently Asked Questions

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

Are there any participants needed for this clinical trial?

"The clinical trial in question is not recruiting patients at this time, based on the information available on clinicaltrials.gov. This particular study was first posted on March 1st, 2000 and last updated November 5th, 2013. Although this specific research project isn't looking for candidates presently, there are 1519 other studies that are currently conducting recruitment drives."

Answered by AI

Does this remedy have the FDA's go-ahead?

"This Phase 3 trial has provided some evidence of efficacy and multiple rounds of safety data, so the Power team rates the safety of this treatment as a 3."

Answered by AI

In how many hospitals is this research project being conducted?

"So far, 44 enrolment centres have been announced for this trial, which include the Ireland Cancer Center in Cleveland, Milton S. Hershey Medical Center in Hershey, and Sutter Cancer Center in Sacramento."

Answered by AI
~14 spots leftby Mar 2025