Back to resultsIn-Vivo Activated T-Cell Depletion to Prevent GVHD
Primary Purpose
Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
Fludarabine
Cyclosporine
Mycophenolate mofetil
Basiliximab
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia
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
Sites / Locations
- Indiana Universtiy Simon Cancer Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
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 to Resolution of Cytopenias: Platelet Transfusion Independence
Average number of days per patient for resolution of cytopenias.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00594308
Brief Title
In-Vivo Activated T-Cell Depletion to Prevent GVHD
Official Title
In-Vivo Activated T-Cell Depletion to Prevent GVHD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Treatment ineffective
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
60mg/kg/day for two consecutive days (-7,-6).
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
25mg/m2/day for 5 consecutive days
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Description
3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1.
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Intervention Description
1000 mg will be administered through day +60 and then discontinued if there is no GVHD.
Intervention Type
Drug
Intervention Name(s)
Basiliximab
Intervention Description
20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.
Primary Outcome Measure Information:
Title
Number of Patients With Acute Grade II-IV GVHD
Description
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 Outcome Measure Information:
Title
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
Title
Number of Days for Absolute Neutrophil Count to Recover
Description
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)
Title
Time to Resolution of Cytopenias: Platelet Transfusion Independence
Description
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)
Title
Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.
Description
Number of patients who died due to transplant related toxicities
Time Frame
up to 2 years after stem cell transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Nelson, MD
Organizational Affiliation
Indiana Universtiy School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana Universtiy Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
In-Vivo Activated T-Cell Depletion to Prevent GVHD
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