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

• ClinicalTrials.gov Identifier: NCT00146614
• Recruitment Status: Completed
• First Posted: September 7, 2005
• Last Update Posted: March 8, 2012
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; Massachusetts General Hospital
• Information provided by (Responsible Party): Edwin P. Alyea, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: September 6, 2005
• First Posted Date: September 7, 2005
• Last Update Posted Date: March 8, 2012
• Study Start Date: July 2002
• Actual Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 6, 2005): To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation
• Official Title: Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Graft Versus Host Disease
• Hematologic Malignancies

Intervention

• Drug: Sirolimus
• Drug: Tacrolimus
• Drug: Methotrexate
• Procedure: Stem Cell Transplantation

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 6, 2005): 105
• Original Enrollment: Same as current
• Actual Study Completion Date: April 2003
• Actual Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00146614
• Other Study ID Numbers: 02-057
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Edwin P. Alyea, MD, Dana-Farber Cancer Institute
• Study Sponsor: Dana-Farber Cancer Institute

Collaborators

• Brigham and Women's Hospital
• Beth Israel Deaconess Medical Center
• Massachusetts General Hospital

Investigators

• Principal Investigator: Edwin P. Alyea, MD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: March 2012