5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
Sponsor:
Virginia Commonwealth University
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00721214
First received: July 22, 2008
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
Patients with high risk myelodysplastic syndrome (MDS) responding to 5-azacytidine prior to allogeneic transplant have improved event free and overall survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome |
Drug: 5-azacytidine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Myelodysplastic Syndromes
Drug Information available for:
Azacitidine
U.S. FDA Resources
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- 1 year and 2-year event free and overall survival (EFS and OS) from the time of transplant. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary endpoints will include intent to treat analysis of 1-year and 2-year EFS and OS for all patients receiving 5-Azacytidine from the time of initial therapy as well as engraftment of WBC and platelets, graft failure, relapse and GVHD. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
5-azacytidine
|
Drug: 5-azacytidine
The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 </=1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis
- Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) levels </=2 x ULN
- Serum creatinine levels </=1.5 x ULN
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721214
Locations
| United States, Virginia | |
| Massey Cancer Center / Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
Sponsors and Collaborators
Virginia Commonwealth University
Celgene Corporation
Investigators
| Study Chair: | John M. McCarty, MD | Virginia Commonwealth University |
More Information
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00721214 History of Changes |
| Other Study ID Numbers: | MCC-11328 |
| Study First Received: | July 22, 2008 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
|
Myelodysplastic Syndrome 5-azacytidine allogeneic stem cell transplantation |
Additional relevant MeSH terms:
|
Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Azacitidine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013