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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up visits following post-remission therapy
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ course 1/course 2 day 37 bone marrow assessments and confirmation bone marrow 30 days later
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~course 1/course 2 day 37 bone marrow assessments and confirmation bone marrow 30 days later
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of CR + CRi (which includes CRc and CRd) will be determined by assessing the proportion of patients who achieved CR or CRi among all evaluable patients.
Secondary outcome measures
Median duration of remission and median duration of disease free survival.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a type of leukemia (AML) that is not the M3 type.I have an active hepatitis B or C infection, or another active liver disease.I have not had major surgery or radiation therapy in the last 4 weeks.I can fully participate in all parts of the clinical trial.I haven't had chemotherapy for MDS in the last 4 weeks.My heart's pumping ability is good, confirmed by a test within the last 2 weeks.My chest X-ray and CT show a lung infection.I have lasting side effects from previous MDS treatment.I was treated for a non-blood condition or diagnosed with MDS for 3+ months.I have been diagnosed with a specific type of leukemia called FAB M3.My leukemia is affecting my brain or spinal cord.I have received initial treatment for acute myeloid leukemia.I can take care of myself but might not be able to do heavy physical work.My liver tests are within normal limits.My kidney function is within normal limits.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any life-threatening side effects to taking Amonafide and Cytarabine?
"The safety of amonafide and cytarabine has been well-documented in clinical trials, so it received a score of 3."
Answered by AI
What are the conditions that Amonafide and Cytarabine have been shown to improve?
"Acute myelocytic leukemia is commonly treated with a combination of amonafide and cytarabine. This treatment intervention can also be effective for other blood cancers like blast phase chronic myelocytic leukemia, lymphoma, and prophylaxis of meningeal leukemia."
Answered by AI
In how many different facilities is this research project being carried out today?
"This trial currently has 33 patients enrolled from various locations such as Thomas Jefferson University in Philadelphia, Cancer Center of the Carolinas in Greenville, and Rush University Medical Center in Chicago."
Answered by AI
Are there any other published research papers that mention both Amonafide and Cytarabine?
"There are 277 clinical trials researching the effects of amonafide and cytarabine, with 67 of those in Phase 3. New york has several ongoing studies, but there are 12485 total locations for research on amonafide and cytarabine."
Answered by AI
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