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Anti-metabolites

5-Azacitidine + Decitabine for Myelodysplastic Syndrome

Phase < 1

Recruiting

Led By Benjamin H Tomlinson, Tomlinson

Research Sponsored by Benjamin Tomlinson

Eligibility Criteria Checklist

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

Must have

Participants must have MDS or MDS/myeloproliferative overlap disorder with potential sensitivity to HMA therapy, defined as prior published evidence of response to HMA

Participants must have performance status of 60% or greater by Karnofsky Performance Status (KPS)

Must not have

Toxicity (grade 2 or higher) from prior therapies including chemotherapy, targeted therapy, immunotherapy, experimental therapy, radiation or surgery must be resolved to grade 1 or less

MDS with IPSS-R high or very high risk, or IPSS intermediate-2 or high risk disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 12 weeks, 24 weeks and up to 2 years from end of treatment

Awards & highlights

Approved for 5 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is studying how well 5-azacitidine and decitabine work when given together in treating patients with myelodysplastic syndrome.

Who is the study for?

This trial is for individuals with myelodysplastic syndrome or related disorders who may benefit from HMA therapy. They must be in a condition to perform daily activities at least 60% of their capacity and have organs functioning well enough to handle the treatment. Participants need to understand and consent to the study, but can't join if they've had certain high-risk MDS, previous similar treatments, other ongoing conditions that could affect safety, are pregnant/breastfeeding, unwilling to use contraception or have unresolved severe side effects from past therapies.

What is being tested?

The trial tests alternating low doses of two FDA-approved chemotherapy drugs, 5-azacytidine (5AZA) and decitabine (DEC), for treating bone marrow failure syndromes like myelodysplastic syndrome. The goal is to see if this approach can overcome resistance seen when these drugs are used alone by affecting DNA metabolism in abnormal cells.

What are the potential side effects?

Potential side effects include damage not only to abnormal cells but also normal ones due to the nature of chemotherapy which affects cell DNA. This might lead to fatigue, nausea, infections due to lowered white blood cell counts, bleeding issues from reduced platelets and anemia caused by fewer red blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have MDS or MDS/myeloproliferative disorder and may respond to HMA therapy.

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I am mostly independent and can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Any severe side effects from my previous cancer treatments have improved.

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My MDS is classified as high risk or very high risk.

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I am not willing to use two forms of birth control.

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I have previously been treated with azacitidine, decitabine, or similar drugs.

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I am a sexually active male unwilling to use condoms with women who can get pregnant.

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I am allergic to components in azacitidine or decitabine treatments.

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I have an active HIV infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 12 weeks, 24 weeks and up to 2 years from end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 12 weeks, 24 weeks and up to 2 years from end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 12 weeks, 24 weeks and up to 2 years from end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR) of 5AZA-alt-DEC

Secondary study objectives

Cumulative incidence of response for both CR and overall response

Duration of response (DOR)

Safety evaluation by tabulation of all AEs and SAEs per CTACE version 5.0

Other study objectives

Correlation of clinical response IWG criteria with disease biological phenotype

Correlation of predicted DNMT1 depletion with clinically assessed DNMT1 depletion as evaluated by flow cytometry

Correlation of predicted DNMT1 depletion with clinically assessed DNMT1 depletion as evaluated by quantitative immunofluorescence

+3 more

Awards & Highlights

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 5AZA-alt-DECExperimental Treatment2 Interventions

Participants will be treated for a minimum of 24 weeks in the absence of clear evidence of progressive disease. Patients who have any response will be permitted to continue treatment until relapse or progression of disease that is not sensitive to protocol defined dose escalation. Treatments will include: 5-azacytidine (50mg/m\^2) Day 1 every week Decitabine (5mg/m\^2) Day 4 every week Weeks 1-8 will be an induction phase, and weeks 9+ will be a long-term treatment phase

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

FDA approved

Decitabine

FDA approved

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Benjamin TomlinsonLead Sponsor

3 Previous Clinical Trials

87 Total Patients Enrolled

Benjamin H Tomlinson, TomlinsonPrincipal InvestigatorCleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center