Multiple Myeloma Clinical Trial
Official title:
In-Vivo Activated T-Cell Depletion to Prevent GVHD
Verified date | September 2014 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 10 |
Est. completion date | |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Indiana Universtiy Simon Cancer Center | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | Yes | |
Secondary | 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) | Yes |
Secondary | 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) | Yes |
Secondary | 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 | Yes |
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