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Trial record 14 of 1597 for:    Farber's Disease

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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00146614
First received: September 6, 2005
Last updated: March 6, 2012
Last verified: March 2012
  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.


Condition Intervention Phase
Graft Versus Host Disease
Hematologic Malignancies
Drug: Sirolimus
Drug: Tacrolimus
Drug: Methotrexate
Procedure: Stem Cell Transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.

Estimated Enrollment: 105
Study Start Date: July 2002
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146614

Locations
United States, Massachusetts
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Investigators
Principal Investigator: Edwin P. Alyea, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Edwin P. Alyea, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00146614     History of Changes
Other Study ID Numbers: 02-057
Study First Received: September 6, 2005
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Graft versus Host Disease
GVHD
Stem Cell Transplantation
Tacrolimus
Sirolimus
Methotrexate
allogeneic stem cell transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Everolimus
Methotrexate
Sirolimus
Tacrolimus
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014