Phase 2
Completed N=29
Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation
graft-versus-host disease · GVHD
Source: ClinicalTrials.gov NCT00282282 ↗
Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Apr 2014
Primary outcomePrimary: Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus. — 5 participants
Summary
The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how effective it is in preventing graft versus host disease (GVHD)in patients that have received non-myeloablative peripheral blood stem cell transplantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus. |
5 | — |
| SECONDARY Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation |
78 | — |
| SECONDARY Disease Response. |
48 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation
- Availability of a related donor who is identical at 6 HLA loci
- Greater than 18 years of age
- Performance status 0-2
- Life expectancy of > 100 days
Exclusion Criteria
- Pregnancy
- Evidence of HIV infection
- Heart failure uncontrolled medication
- Total bilirubin > 2.0mg/dl that is due to hepatocellular dysfunction
- AST >90
- Serum Creatinine >2.0
- Cholesterol > 300mg/dl while adequately treated
Data sourced from ClinicalTrials.gov (NCT00282282). 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.