Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation

Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00146614

Enrollment

105

Registered

2005-09-07

Start date

2002-07-31

Completion date

2003-04-30

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease, Hematologic Malignancies

Keywords

Graft versus Host Disease, GVHD, Stem Cell Transplantation, Tacrolimus, Sirolimus, Methotrexate, allogeneic stem cell transplantation

Brief summary

The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.

Detailed description

* Patients will be admitted to the hospital and receive chemotherapy and stem cell transplant(SCT). The total duration of hospitalization for the procedure is approximately 8 days. Once admitted the patient will receive fludarabine daily for 4 days, busulfex once daily for 4 days. Two days after chemotherapy has ended, the patient will receive the infusion of donor cells. * Just prior to the transplant and following the transplant, patients will receive sirolimus (orally), tacrolimus (orally) and low doses of methotrexate (chemotherapy). Methotrexate will be given on days 1,3 and 6 after transplant. * Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible. * Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible. * Patients will also receive medication to help prevent possible infection. * After stem cell infusion, patients will be examined and have blood tests weekly for 1 month. At the 1 month visit, a bone marrow biopsy will performed looking for evidence of donor cells in the bone marrow. After the one month evaluation the patient will be examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant.

Interventions

DRUGSirolimus

DRUGTacrolimus

DRUGMethotrexate

PROCEDUREStem Cell Transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation. * Donors (both related and unrelated) who are identical at 6 HLA loci. * Age greater than 18 * ECOG Performance Status 0-2 * Life expectancy of greater than 100 days.

Exclusion criteria

* Pregnancy * Evidence of HIV infection * Heart failure uncontrolled by medications * Total Bilirubin \> 2.0mg/dl due to hepatocellular dysfunction * AST \> 90 * Serum creatinine \> 2.0 * Cholesterol \> 300 mg/dl

Design outcomes

Primary

Measure	Time frame
To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026