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Anti-metabolites
VNP40101M + Cytarabine for Leukemia
Phase 2
Waitlist Available
Research Sponsored by Vion Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Significant arrhythmia, including atrial flutter (excluding atrial fibrillation), sick sinus syndrome, ventricular arrhythmia
Must have ≥ 1 of the following poor-risk features: Any of the following unfavorable cytogenetics: Del (5q)/-5q, -7/del(7q), Abnormal 3q, 9q, 11q, 20q, 21q, or 17p, t(6;9), t(9;22), Trisomy 8, Complex karyotypes (≥ 3 unrelated abnormalities), At least 70 years of age, ECOG performance status (PS) of 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying VNP40101M followed by cytarabine to see if it can kill more cancer cells in older patients with acute myeloid leukemia.
Who is the study for?
This trial is for older patients with acute myeloid leukemia (AML) who have specific genetic changes in their cancer cells or are at least 70 years old. They should not have a history of other blood disorders, previous chemotherapy for non-AML diseases, severe heart or lung conditions, liver cirrhosis, or any other major organ dysfunction that would make standard treatment risky.Check my eligibility
What is being tested?
The study is testing the effectiveness of a chemotherapy drug called VNP40101M followed by another drug named cytarabine. The goal is to see if this combination works better at stopping AML cancer cells from growing and dividing in older adults compared to current treatments.See study design
What are the potential side effects?
Chemotherapy drugs like VNP40101M and cytarabine can cause side effects such as nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood cell counts, bleeding problems from low platelets and potential damage to organs like the heart and liver.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a serious irregular heartbeat condition.
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I am over 70 or have a specific poor-risk feature in my cancer diagnosis.
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I have heart issues that could affect certain cancer treatments.
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My leukemia was diagnosed as AML from the start.
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I have lung issues not caused by AML, with moderate breathing difficulties.
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I have liver problems due to long-term hepatitis or cirrhosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate
Secondary outcome measures
Leukemia-free survival
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Who is running the clinical trial?
Vion PharmaceuticalsLead Sponsor
22 Previous Clinical Trials
841 Total Patients Enrolled
8 Trials studying Leukemia
735 Patients Enrolled for Leukemia
Bonny L. Johnson, RN, MSNVion Pharmaceuticals
4 Previous Clinical Trials
567 Total Patients Enrolled
3 Trials studying Leukemia
480 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a specific type of leukemia (acute promyelocytic).I have AML without a history of blood disorders or prior cancer treatments.My cancer does not have certain genetic features known to respond well to treatment.It has been more than 24 hours since I last took metronidazole.I have a serious irregular heartbeat condition.I do not have any known brain or spinal cord diseases.I have chronic hepatitis.I do not have any ongoing, untreated infections.I am over 70 or have a specific poor-risk feature in my cancer diagnosis.I have heart issues that could affect certain cancer treatments.I am not taking disulfiram.My leukemia was diagnosed as AML from the start.I have lung issues not caused by AML, with moderate breathing difficulties.I have health issues that prevent me from receiving standard cancer treatment.I am not on any AML treatments except possibly hydroxyurea or leukapheresis as specified.I have not had low-dose chemotherapy before.I can take care of myself and perform daily activities.I have liver problems due to long-term hepatitis or cirrhosis.I do not have any other cancer besides AML or MDS.I may have heart valve disease, but mitral valve prolapse is okay.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 remaining vacancies for individuals to join this medical experiment?
"The information present on clinicaltrials.gov indicates that this particular trial is presently closed to recruitment, having been first posted in May of 2006 and last updated January 9th 2014. There are however 1409 other viable trials actively recruiting patients at the moment."
Answered by AI
Is this medicinal procedure without risk to patients?
"Our assessment of the safety profile assigned a score of 2 to this treatment, as Phase 2 trials have not yet produced clinical data demonstrating its efficacy."
Answered by AI
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