Phase 2 N=29 Treatment

Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation

Graft Versus Host Disease · GVHD

Bottom Line

View on ClinicalTrials.gov: NCT00282282 ↗

Enrolled (actual)

Serious AEs

3.5%

Results posted

Apr 2014

Primary outcome: Primary: Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus. — 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: tacrolimus (Drug); sirolimus (Drug); fludarabine (Drug); busulfex (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dana-Farber Cancer Institute
Primary completion: Jan 2009

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	—

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.

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

View full record on ClinicalTrials.gov →

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.