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In-Vivo Activated T-Cell Depletion to Prevent GVHD

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III, Phase II

Supportive care, Treatment

Active

18 to 75

Other

0705-20 IUCRO-0196
NCT00594308

Trial Description

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).

Eligibility Criteria

Inclusion Criteria:

Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol

Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis.

Exclusion Criteria:

Active CNS disease (the presence of leukemic blasts in the CSF)

Pregnancy or breast-feeding

SGOT >3x upper limit of normal

Creatinine >2 or creatinine clearance <50cc/hr.

Fractional shortening by echocardiogram not within normal limits per institution

Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia

Prior allogeneic transplant

Trial Contact Information

Trial Lead Organizations/Sponsors

Indiana University Melvin and Bren Simon Cancer Center

Robert Nelson, MD

Principal Investigator

Wood Lisa, RN		Ph: 317-274-1781
		Email: llwood@iupui.edu

Robert Nelson, MD		Ph: 317-278-6871
		Email: ronelson@iupui.edu

Trial Sites

U.S.A.

Indiana

Indianapolis

Indiana University Melvin and Bren Simon Cancer Center

Lisa Wood, RN Ph: 317-274-1781

Email: llwood@iupui.edu

Robert Nelson, MD Ph: 317-278-6871

Email: ronelson@iupui.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00594308
Information obtained from ClinicalTrials.gov on July 31, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.