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Topoisomerase II Inhibitor

Amonafide vs Daunorubicin for Acute Myeloid Leukemia

Phase 3
Waitlist Available
Research Sponsored by Antisoma Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of AML according to WHO diagnostic criteria with at least 20% blasts in the peripheral blood or bone marrow, excluding FAB M3
ECOG performance score =< 2
Must not have
Known active hepatitis B or C, or any other active liver disease
Parenchymal abnormality on screening chest x-ray with evidence of pulmonary infection on chest CT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial compares amonafide to daunorubicin, both in combination with cytarabine, to see which is more effective and has fewer side effects in patients with secondary AML.

Who is the study for?
Adults with secondary AML who haven't had treatment for it yet. They need to be fairly healthy, able to follow the trial procedures, and have good heart, kidney, and liver function. Women must test negative for pregnancy and all participants should agree to use contraception.
What is being tested?
The study is testing Amonafide combined with Cytarabine against Daunorubicin with Cytarabine in treating secondary AML. It aims to compare their effectiveness and safety in a randomized setting where patients are assigned by chance.
What are the potential side effects?
Potential side effects include reactions related to the infusion process, impact on organ functions due to DNA interaction of drugs, fatigue, digestive issues like nausea or diarrhea, blood-related problems such as anemia or bleeding risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a type of leukemia (AML) that is not the M3 type.
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I can take care of myself but might not be able to do heavy physical work.
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My liver tests are within normal limits.
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My kidney function is within normal limits.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active hepatitis B or C infection, or another active liver disease.
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My chest X-ray and CT show a lung infection.
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I have lasting side effects from previous MDS treatment.
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I have been diagnosed with a specific type of leukemia called FAB M3.
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My leukemia is affecting my brain or spinal cord.
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I have received initial treatment for acute myeloid leukemia.

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment1 Intervention
Amonafide in Combination with Cytarabine
Group II: Arm BActive Control1 Intervention
Daunorubicin in Combination with Cytarabine

Find a Location

Who is running the clinical trial?

Antisoma ResearchLead Sponsor
10 Previous Clinical Trials
553 Total Patients Enrolled

Media Library

Amonafide (Topoisomerase II Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00715637 — Phase 3
Acute Myeloid Leukemia Research Study Groups: Arm B, Arm A
Acute Myeloid Leukemia Clinical Trial 2023: Amonafide Highlights & Side Effects. Trial Name: NCT00715637 — Phase 3
Amonafide (Topoisomerase II Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00715637 — Phase 3
~23 spots leftby Sep 2025
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