Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation

NCT ID: NCT00282282

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-07-31

Brief Summary

The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how effective it is in preventing graft versus host disease (GVHD)in patients that have received non-myeloablative peripheral blood stem cell transplantation.

Detailed Description

• After the screening procedures confirm that the patient is eligible to participate in the research study, they will be admitted to the hospital to receive chemotherapy and stem cell transplantation (SCT). The duration of the hospitalization for the procedure is approximately 8 days.
• Patients will receive fludarabine once daily over 30 minutes intravenously for 4 days and busulfex once daily over 3 hours intravenously each day for the same 4 days.
• Just prior to the transplant and following the transplant the patient will receive sirolimus and tacrolimus to help prevent Graft versus Host Disease (GvHD). Both medications are taken orally.
• Patients will also take medications to help prevent possible infections (e.g. acyclovir). Filgrastim, a white blood cell growth factor, will be given daily in an injection under the skin, starting the day after the stem cell transplant and until the patients blood counts have recovered.
• After the stem cell infusion, the patient will be examined and have blood tests weekly for 1 month. At about the 1-month visit, a bone marrow biopsy and/or blood tests will be performed to determine the percentage of donor's cells in the blood or bone marrow. These tests will be repeated at 3-4 months after transplant.
• At 3-4 months after the transplant, patients will also have tests to reassess the response of your disease to transplant. This may involve a bone marrow biopsy, blood tests, and/or radiology studies depending upon the type of cancer.
• Follow-up will continue for the remainder of the patients life.

Conditions

Graft Versus Host Disease; GVHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

tacrolimus

Given orally just prior to and following stem cell transplant

Intervention Type: DRUG

sirolimus

Given orally just prior to and following stem cell transplant

Intervention Type: DRUG

fludarabine

Given once daily over 30 minutes for 4 days

Intervention Type: DRUG

busulfex

Given intravenously over 3 hours for 4 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation
• Availability of a related donor who is identical at 6 HLA loci
• Greater than 18 years of age
• Performance status 0-2
• Life expectancy of > 100 days

Exclusion Criteria

• Pregnancy
• Evidence of HIV infection
• Heart failure uncontrolled medication
• Total bilirubin > 2.0mg/dl that is due to hepatocellular dysfunction
• AST >90
• Serum Creatinine >2.0
• Cholesterol > 300mg/dl while adequately treated

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Vincent T. Ho, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincent Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Ho VT, Aldridge J, Kim HT, Cutler C, Koreth J, Armand P, Antin JH, Soiffer RJ, Alyea EP. Comparison of Tacrolimus and Sirolimus (Tac/Sir) versus Tacrolimus, Sirolimus, and mini-methotrexate (Tac/Sir/MTX) as acute graft-versus-host disease prophylaxis after reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation. Biol Blood Marrow Transplant. 2009 Jul;15(7):844-50. doi: 10.1016/j.bbmt.2009.03.017.

Reference Type: RESULT

PMID: 19539216 (View on PubMed)

Other Identifiers

05-362

Identifier Type: -

Identifier Source: org_study_id