Clinical trial NCT00594308: In-Vivo Activated T-Cell Depletion to Prevent GVHD
Official title: In-Vivo Activated T-Cell Depletion to Prevent GVHD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Patients With Acute Grade II-IV GVHD
timeFrame: until 30 days after stem cell transplant
Secondary outcomes:
measure: Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
timeFrame: until 30 days after stem cell transplant
measure: Number of Days for Absolute Neutrophil Count to Recover
timeFrame: From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)
measure: Time to Resolution of Cytopenias: Platelet Transfusion Independence
timeFrame: From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)
measure: Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.
timeFrame: up to 2 years after stem cell transplant
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Universtiy Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana Universtiy School of Medicine
name: Robert Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References: