In-Vivo Activated T-Cell Depletion to Prevent GVHD

NCT ID: NCT00594308

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31

Brief 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

Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Myelodysplasia; Lymphoma, Non-Hodgkin's; Mantle-Cell Lymphoma; Hodgkin's Disease; Multiple Myeloma; Myelofibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cyclophosphamide

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

Intervention Type: DRUG

Fludarabine

25mg/m2/day for 5 consecutive days

Intervention Type: DRUG

Cyclosporine

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

Intervention Type: DRUG

Mycophenolate mofetil

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

Intervention Type: DRUG

Basiliximab

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana Universtiy School of Medicine

Locations

Indiana Universtiy Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0705-20 IUCRO-0196

Identifier Type: -

Identifier Source: org_study_id