Phase 2
Completed N=16
5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome
Source: ClinicalTrials.gov NCT00721214 ↗Enrolled (actual)
16
Serious AEs
81.3%
Results posted
Aug 2015
Primary outcomePrimary: One Year Overall Survival of Allogeneic Transplant Recipients After Transplantation — 50 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY One Year Overall Survival of Allogeneic Transplant Recipients After Transplantation |
50 | — |
| PRIMARY Two Year Overall Survival of Allogeneic Transplant Recipients After Transplantation |
50 | — |
| PRIMARY One Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation |
50 | — |
| PRIMARY Two Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation |
50 | — |
| SECONDARY One-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts |
47 | — |
| SECONDARY Two-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts. |
37 | — |
| SECONDARY One-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts |
47 | — |
| SECONDARY Two-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts |
37 | — |
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 </=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
Data sourced from ClinicalTrials.gov (NCT00721214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.