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

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00146614

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer

Drug Information available for: Methotrexate Sirolimus Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

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

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

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Isreal Deaconess Medical Center
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

Study ID Numbers:	02-057
Study First Received:	September 6, 2005
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00146614 History of Changes
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

Study placed in the following topic categories:

Sirolimus
Antimetabolites
Anti-Infective Agents
Hematologic Neoplasms
Immunologic Factors
Hematologic Diseases
Folate
Tacrolimus
Folinic Acid
Folic Acid Antagonists

Immunosuppressive Agents
Vitamin B9
Homologous Wasting Disease
Graft Versus Host Disease
Folic Acid
Anti-Bacterial Agents
Antifungal Agents
Graft vs Host Disease
Methotrexate
Antirheumatic Agents

Additional relevant MeSH terms:

Sirolimus
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Hematologic Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Tacrolimus
Antibiotics, Antineoplastic
Anti-Bacterial Agents
Neoplasms by Site
Antifungal Agents

Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Immune System Diseases
Hematologic Diseases
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Graft vs Host Disease
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 04, 2009