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In-Vivo Activated T-Cell Depletion to Prevent GVHD

NCT00594308 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-10-06

Study results available
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Summary

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease.

This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).

Conditions

Interventions

DRUG

Cyclophosphamide

60mg/kg/day for two consecutive days (-7,-6).

DRUG

Fludarabine

25mg/m2/day for 5 consecutive days

DRUG

Cyclosporine

3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1.

DRUG

Mycophenolate mofetil

1000 mg will be administered through day +60 and then discontinued if there is no GVHD.

DRUG

Basiliximab

20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Robert Nelson, MD · Indiana Universtiy School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00594308 on ClinicalTrials.gov