In-Vivo Activated T-Cell Depletion to Prevent GVHD

Indiana University10 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia

Interventions

CyclophosphamideDRUG

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

FludarabineDRUG

25mg/m2/day for 5 consecutive days

CyclosporineDRUG

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

Mycophenolate mofetilDRUG

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

BasiliximabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Patients With Acute Grade II-IV GVHD

Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.

Time frame: until 30 days after stem cell transplant

Secondary Outcomes

Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).

Time frame: until 30 days after stem cell transplant

Number of Days for Absolute Neutrophil Count to Recover

Average number of day per patient for absolute neutrophil count to recover(\> 500/mm3 for 3 consecutive days).

Time frame: From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)

Time to Resolution of Cytopenias: Platelet Transfusion Independence

Average number of days per patient for resolution of cytopenias.

Time frame: From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)

Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.

Number of patients who died due to transplant related toxicities

Time frame: up to 2 years after stem cell transplant