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Anti-metabolites

Decitabine vs Azacitidine for Myelodysplastic Syndrome

Q: Are there several medical centers conducting this research in the city?

<p>The Cleveland Clinic Foundation in <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>, NYP/Weill Cornell Medical Center located in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> City, and Johns Hopkins University/Sidney Kimmel <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Centre situated in <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a> are <a href="https://www.withpower.com/clinical-trials/all">all</a> coordinating the study along with 6 other sites.</p>

Phase 2

Waitlist Available

Led By Guillermo Garcia-Manero

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years.

IPSS low- or intermediate-1-risk MDS, including CMML-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

Study Summary

This trial is looking at two drugs to see if they can help control MDS and what the safety profile is when given on a shorter than standard schedule.

Who is the study for?

This trial is for adults (18+) with low to intermediate-1 risk MDS, including CMML-1. Participants must have adequate organ function and performance status, not be breastfeeding, and agree to use contraception. Those who've had prior treatment with decitabine or azacitidine are excluded.Check my eligibility

What is being tested?

The study compares two FDA-approved drugs for MDS—decitabine (DAC) and azacitidine (AZA)—administered on a non-standard schedule to see which better controls the disease. Up to 240 patients will participate in this multicenter Phase II trial.See study design

What are the potential side effects?

Potential side effects of DAC and AZA include nausea, vomiting, fatigue, injection site reactions, blood count changes leading to increased infection risk or bleeding tendencies, liver enzyme alterations, and kidney function impairment.

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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My condition is low or intermediate-1 risk according to the IPSS.

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I can care for myself but may not be able to do any physical work.

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My kidney and liver functions are within the required limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event Free Survival (EFS)

Secondary outcome measures

Overall improvement rate (OIR)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Decitabine (DAC)Experimental Treatment1 Intervention

Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.

Group II: Best Supportive Care (BSC)Experimental Treatment1 Intervention

Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.

Group III: Azacitidine (AZA) - Days 1 - 5Experimental Treatment1 Intervention

Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.

Group IV: Azacitidine (AZA) - Days 1 - 3Experimental Treatment1 Intervention

Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,513 Total Patients Enrolled

451 Trials studying Leukemia

31,199 Patients Enrolled for Leukemia

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,885 Total Patients Enrolled

1,512 Trials studying Leukemia

384,414 Patients Enrolled for Leukemia

Guillermo Garcia-ManeroPrincipal InvestigatorM.D. Anderson Cancer Center

9 Previous Clinical Trials

1,290 Total Patients Enrolled

6 Trials studying Leukemia

1,063 Patients Enrolled for Leukemia

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02269280 — Phase 2

Leukemia Research Study Groups: Azacitidine (AZA) - Days 1 - 3, Azacitidine (AZA) - Days 1 - 5, Decitabine (DAC), Best Supportive Care (BSC)

Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT02269280 — Phase 2

Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02269280 — Phase 2

Frequently Asked Questions

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

How many participants are currently enlisted in this research?

"Unfortunately, recruitment for this trial has ceased. It launched on October 13th 2014 and was last updated July 21st 2020. There are presently 1561 trials seeking participants with leukemia and 264 trials recruiting patients that plan to use Azacitidine (AZA) Days 1 - 3 intervention protocol."

Answered by AI

Have any other investigations explored the efficacy of administering Azacitidine (AZA) on Days 1 - 3?

"In 2004, the Central Illinois Hematology Oncology Center was one of the earliest sites to study Azacitidine (AZA) Days 1-3. Since then, it has been subject to 279 completed medical trials and an additional 264 ongoing investigations with many taking place in Cleveland, Ohio."

Answered by AI

What potential risks may be associated with Azacitidine (AZA) administration on the first three days?

"Although its efficacy has yet to be proven, Azacitidine (AZA) Days 1 - 3 scored a 2 on the scale of safety due to existing research evidence."

Answered by AI

Are there any open enrollment opportunities for this research project?

"According to clinicaltrials.gov, this research project is no longer actively seeking participants as of July 21st 2020; the trial was initially posted on October 13th 2014. Nevertheless, there are 1825 other trials with available slots at present."

Answered by AI

Are there several medical centers conducting this research in the city?

"The Cleveland Clinic Foundation in Ohio, NYP/Weill Cornell Medical Center located in New york City, and Johns Hopkins University/Sidney Kimmel Cancer Centre situated in Maryland are all coordinating the study along with 6 other sites."

Answered by AI

What therapeutic objectives are most frequently addressed by Azacitidine (AZA) over the first three days?

"Azacitidine (AZA) Days 1 - 3 is an effective induction chemotherapy for a variety of conditions, including ipss risk category intermediate-2, refractory anemias, and acute myelocytic leukemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)

2014. "Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02269280.

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