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

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ClinicalTrials.gov Identifier: NCT00282282
Recruitment Status : Completed
First Posted : January 26, 2006
Results First Posted : April 8, 2014
Last Update Posted : May 12, 2014
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Vincent T. Ho, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 24, 2006
First Posted Date  ICMJE January 26, 2006
Results First Submitted Date  ICMJE January 11, 2013
Results First Posted Date  ICMJE April 8, 2014
Last Update Posted Date May 12, 2014
Study Start Date  ICMJE January 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2014)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2006)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2014)
  • Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation [ Time Frame: 100 days ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2006)
  • To assess donor stem cell engraftment, including donor-host hematopoietic chimerism studies post transplant
  • to assess disease response.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation
Official Title  ICMJE Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis After Allogeneic Non-myeloablative Peripheral Blood Stem Cell Transplantation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Graft Versus Host Disease
  • GVHD
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2014)
31
Original Enrollment  ICMJE
 (submitted: January 24, 2006)
30
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282282
Other Study ID Numbers  ICMJE 05-362
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vincent T. Ho, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Brigham and Women's Hospital
Investigators  ICMJE
Principal Investigator: Vincent Ho, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP