Myelodysplastic Syndrome Clinical Trial

Clinical Trial Finder Myelodysplastic Syndrome Trials

5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome

See Locations Near You

Summary

The purpose of this study is to examine the feasibility and efficacy of using the demethylating agent 5-Azacytidine prior to allogeneic stem cell transplantation in patients with high risk myelodysplastic syndrome (MDS).

View Full Description

Full Description

The study drug, 5-azacytidine, is given daily intravenously for 7 days. After every 2 cycles study participants will have a bone marrow test to evaluate the effect of the 5-azacytidine on the Myelodysplastic Syndrome (MDS). Participants continue to get cycles of 5-Azacytidine until 2 bone marrow tests show the MDS has stopped responding to the treatment. At that time they will undergo a transplant if a donor is available.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients fulfilling the following criteria will be eligible for study entry:

Diagnosis of MDS according to WHO criteria
Intermediate-2 or high risk by IPSS score
Clinically able to receive 5-Azacytidine
Serum bilirubin levels Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) levels Serum creatinine levels Negative serum pregnancy test prior to 5-Azacytidine treatment for women of childbearing potential
Women and men of childbearing potential agree to use contraception while receiving treatment with 5-Azacytidine
Potentially eligible for allogeneic transplantation
No prior allogeneic transplant
Age 18 to 70, inclusive.

Exclusion Criteria:

Known or suspected hypersensitivity to 5-azacytidine or mannitol
Patients previously treated with 5-azacytidine or deoxyazacytidine
Pregnant or breast feeding
Patients with advanced malignant hepatic tumors

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00721214

Recruitment Status:

Completed

Sponsor:

Virginia Commonwealth University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Massey Cancer Center / Virginia Commonwealth University
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00721214

Recruitment Status:

Completed

Sponsor:


Virginia Commonwealth University

How clear is this clinincal trial information?

Clinical Trial Resources

Why I’d Choose a Clinical Trial For Myself
SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
Clinical Trials Can be Life-Saving for Some
×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider