Boston, Massachusetts 02115

  • Hematologic Malignancies

Purpose:

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.


Study summary:

- 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.


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


Study is Available At:


Original ID:

02-057


NCT ID:

NCT00146614


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dana-Farber Cancer Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

105


Enrollment Type:


Overall Contact Information

Official Name:Edwin P. Alyea, MD
Principal Investigator
Dana-Farber Cancer Institute

Study Dates

Start Date:July 2002
Completion Date:April 2003
Completion Type:Actual
Primary Completion Date:April 2003
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 6, 2012
First Received Date:September 6, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Sirolimus
Intervention Type:Drug
Name:Tacrolimus
Intervention Type:Drug
Name:Methotrexate
Intervention Type:Procedure
Name:Stem Cell Transplantation

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dana-Farber Cancer Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:Brigham and Women's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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