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A Phase II Study of the Use of 5-Azacytidine as Pre-Transplant Cytoreduction Prior to Allogeneic Stem Cell Transplantation for High Risk Myelodysplastic Syndromes


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Myelodysplastic Syndrome

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Trial Information

A Phase II Study of the Use of 5-Azacytidine as Pre-Transplant Cytoreduction Prior to Allogeneic Stem Cell Transplantation for High Risk Myelodysplastic Syndromes


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.


Inclusion Criteria:



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

1. Diagnosis of MDS according to WHO criteria

2. Intermediate-2 or high risk by IPSS score

3. Clinically able to receive 5-Azacytidine

4. Serum bilirubin levels laboratory (ULN). Higher levels are acceptable if these can be attributed to
active hemolysis or ineffective erythropoiesis

5. Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic
transaminase (SGPT) levels
6. Serum creatinine levels
7. Negative serum pregnancy test prior to 5-Azacytidine treatment for women of
childbearing potential

8. Women and men of childbearing potential agree to use contraception while
receiving treatment with 5-Azacytidine

9. Potentially eligible for allogeneic transplantation

10. No prior allogeneic transplant

11. Age 18 to 70, inclusive.

Exclusion Criteria:

1. Known or suspected hypersensitivity to 5-azacytidine or mannitol

2. Patients previously treated with 5-azacytidine or deoxyazacytidine

3. Pregnant or breast feeding

4. Patients with advanced malignant hepatic tumors

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1 year and 2-year event free and overall survival (EFS and OS) from the time of transplant.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

John M. McCarty, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Institutional Review Board

Study ID:

MCC-11328

NCT ID:

NCT00721214

Start Date:

July 2008

Completion Date:

December 2013

Related Keywords:

  • Myelodysplastic Syndrome
  • Myelodysplastic Syndrome
  • 5-azacytidine
  • allogeneic stem cell transplantation
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Massey Cancer Center / Virginia Commonwealth UniversityRichmond, Virginia  23298