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


Phase 2
18 Years
N/A
Not Enrolling
Both
Graft Versus Host Disease, Hematologic Malignancies

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Edwin P. Alyea, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

02-057

NCT ID:

NCT00146614

Start Date:

July 2002

Completion Date:

April 2003

Related Keywords:

  • Graft Versus Host Disease
  • Hematologic Malignancies
  • Graft versus Host Disease
  • GVHD
  • Stem Cell Transplantation
  • Tacrolimus
  • Sirolimus
  • Methotrexate
  • allogeneic stem cell transplantation
  • Neoplasms
  • Graft vs Host Disease
  • Hematologic Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Beth Isreal Deaconess Medical CenterBoston, Massachusetts  02215