In-Vivo Activated T-Cell Depletion to Prevent GVHD

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 Overview

• Status: Terminated
• Conditions: Multiple Myeloma; Myelofibrosis; Chronic Lymphocytic Leukemia; Acute Lymphocytic Leukemia; Acute Myelogenous Leukemia; Mantle-Cell Lymphoma; Chronic Myelogenous Leukemia; Lymphoma, Non-Hodgkin's; Myelodysplasia; Hodgkin's Disease
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Cyclosporine; Drug: Mycophenolate mofetil; Drug: Basiliximab

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Universtiy Simon Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	until 30 days after stem cell transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).		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).	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.	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	up to 2 years after stem cell transplant

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Robert Nelson, MD, Indiana Universtiy School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 4, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Estimate): October 6, 2014
• Last Update Submitted That Met QC Criteria: September 26, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Myeloproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Leukemia, B-Cell; Lymphoma; Multiple Myeloma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Hodgkin Disease; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Dermatologic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Cyclophosphamide; Fludarabine; Mycophenolic Acid; Basiliximab; Cyclosporine; Cyclosporins
• Other Study ID Numbers: 0705-20 IUCRO-0196