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Anti-metabolite
Combination Chemotherapy for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Research Sponsored by ALZA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed poor risk myelodysplastic syndrome, including at least one of the following: bilineage cytopenia, unfavorable cytogenetic abnormalities, refractory anemia with excess blasts and/or refractory anemia with excess blast in transformation (greater than 5% blast), at least 0.5 on the International Prognostic Score System, no chronic myelomonocytic leukemia, no hypocellular myelodysplastic syndrome (marrow cellularity less than 30%)
Performance status ECOG 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying giving topotecan and cytarabine with amifostine to see how well it works in treating patients with myelodysplastic syndrome.
Who is the study for?
This trial is for adults (16+) with myelodysplastic syndrome, a bone marrow disorder that can lead to leukemia. Participants should have specific blood cell counts, no severe heart failure or certain types of leukemia, and must not be pregnant. They need an implanted right atrial catheter and agree to use contraception.Check my eligibility
What is being tested?
The study tests the effectiveness of combining two chemotherapy drugs, topotecan and cytarabine, with amifostine—a drug meant to reduce chemo side effects—in patients with myelodysplastic syndrome to see if this mix is better at killing cancer cells.See study design
What are the potential side effects?
Chemotherapy may cause nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts. Amifostine might help protect against some chemo side effects but can also cause dizziness or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood disorder is considered high-risk due to specific poor indicators.
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I am fully active or can carry out light work.
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I am 16 years old or older.
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
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Who is running the clinical trial?
ALZALead Sponsor
3 Previous Clinical Trials
288 Total Patients Enrolled
Henry C. Fung, MD, FRCPEStudy ChairCity of Hope Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood disorder is considered high-risk due to specific poor indicators.I have never taken amifostine.I have never had a blood or bone marrow transplant.I haven't had chemotherapy for acute myeloid leukemia, except possibly hydroxyurea or low dose cytarabine.I am fully active or can carry out light work.I have never been treated with topotecan.I haven't taken blood pressure medication for at least 24 hours before amifostine.I am 16 years old or older.
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.
Is there a high level of risk associated with this treatment plan?
"While Phase 2 trials do not have data supporting efficacy, this team believes that the safety profile of the treatment falls at a 2."
Answered by AI
Are there any available appointments for this research project?
"No, this study is not currently looking for new participants. According to the information on clinicaltrials.gov, the last time this trial was active was December 3rd, 2013. Even though this particular study is not enrolling patients at the moment, there are 2823 other trials that are still recruiting individuals."
Answered by AI
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