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

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Vincent T. Ho, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00282282
First received: January 24, 2006
Last updated: April 29, 2014
Last verified: March 2014
  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: 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:


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

Primary Outcome Measures:
  • Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus. [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    All participants received tacrolimus and sirolimus in this one arm study. There were no participants considered unevaluable for this measure (deceased prior to day 100). The total number of people who developed grade II-IV aGVHD before day 100 are reported here.


Secondary Outcome Measures:
  • Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation [ Time Frame: 100 days ] [ Designated as safety issue: No ]
    The percentage of participants with ≥90 percent donor-derived hematopoeisis was assessed around day +100 using peripheral blood chimerism.

  • Disease Response. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Disease response was assessed as 2 year progression-free survival. The median follow-up time was 1.84 years. The percentage of participants with who reached this timepoint with no disease progression are reported.


Enrollment: 31
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:
    Drug: tacrolimus
    Given orally just prior to and following stem cell transplant
    Drug: sirolimus
    Given orally just prior to and following stem cell transplant
    Drug: fludarabine
    Given once daily over 30 minutes for 4 days
    Drug: busulfex
    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
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: 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

Publications:
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
Results First Received: January 11, 2013
Last Updated: April 29, 2014
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
Everolimus
Sirolimus
Tacrolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014