NCT00282282

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

April 8, 2014

Completed
Last Updated

May 12, 2014

Status Verified

March 1, 2014

Enrollment Period

3 years

First QC Date

January 24, 2006

Results QC Date

January 11, 2013

Last Update Submit

April 29, 2014

Conditions

Graft Versus Host DiseaseGVHD

Keywords

non-myeloablative peripheral blood stem cellPBSCTtacrolimussirolimus

Outcome Measures

Primary Outcomes (1)

  • Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus.

    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.

    100 days

Secondary Outcomes (2)

  • Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation

    100 days

  • Disease Response.

    2 years

Interventions

tacrolimusDRUG

Given orally just prior to and following stem cell transplant

sirolimusDRUG

Given orally just prior to and following stem cell transplant

fludarabineDRUG

Given once daily over 30 minutes for 4 days

busulfexDRUG

Given intravenously over 3 hours for 4 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 19539216RESULT

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

TacrolimusSirolimusfludarabineBusulfan

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsButylene GlycolsGlycolsAlcoholsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur Compounds

Limitations and Caveats

This study is a single-institution study, and as such the data are limited by the small study population.

Results Point of Contact

Title
Vincent T. Ho, MD Associate Professor of Medicine, Harvard Medical School
Organization
Dana-Farber Cancer Institute
vincent_ho@dfci.harvard.edu
(617) 632-5938

Study Officials

  • Vincent Ho, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 26, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

July 1, 2009

Last Updated

May 12, 2014

Results First Posted

April 8, 2014

Record last verified: 2014-03

Locations

US(1)