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

Purpose

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.

Condition	Intervention	Phase
Graft Versus Host Disease GVHD	Drug: tacrolimus Drug: sirolimus Drug: fludarabine Drug: busulfex	Phase 2

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

Resource links provided by NLM:

Drug Information available for: Busulfan Fludarabine Sirolimus Fludarabine phosphate Tacrolimus Everolimus Temsirolimus

U.S. FDA Resources

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

Primary Outcome Measures:

To assess the incidence and severity of grade II-IV acute GvHD developing by day 100 following non-myeloablative PBSC transplantation using tacrolimus and sirolimus. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess donor stem cell engraftment, including donor-host hematopoietic chimerism studies post transplant [ Time Frame: 2 years ] [ Designated as safety issue: No ]
to assess disease response. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2006
Study Completion Date:	July 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Given orally just prior to and following stem cell transplant

Given once daily over 30 minutes for 4 days

Given intravenously over 3 hours for 4 days

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.

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282282

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

Vincent Ho, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Vincent T. Ho, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00282282 History of Changes
Other Study ID Numbers:	05-362
Study First Received:	January 24, 2006
Last Updated:	March 15, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

non-myeloablative peripheral blood stem cell
PBSCT
tacrolimus
sirolimus

Additional relevant MeSH terms:

Graft vs Host Disease
Immune System Diseases
Busulfan
Fludarabine monophosphate
Sirolimus
Everolimus
Tacrolimus
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013