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In-Vivo Activated T-Cell Depletion to Prevent GVHD

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ClinicalTrials.gov Identifier: NCT00594308
Recruitment Status : Terminated (Treatment ineffective)
First Posted : January 15, 2008
Results First Posted : March 20, 2012
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Indiana University

Study Description
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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).


Condition or disease Intervention/treatment Phase
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 Drug: Cyclophosphamide Drug: Fludarabine Drug: Cyclosporine Drug: Mycophenolate mofetil Drug: Basiliximab Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In-Vivo Activated T-Cell Depletion to Prevent GVHD
Study Start Date : October 2007
Actual Primary Completion Date : October 2008

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Arms and Interventions
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Intervention Details:
  • Drug: Cyclophosphamide
    60mg/kg/day for two consecutive days (-7,-6).
  • Drug: Fludarabine
    25mg/m2/day for 5 consecutive days
  • Drug: Cyclosporine
    3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1.
  • Drug: Mycophenolate mofetil
    1000 mg will be administered through day +60 and then discontinued if there is no GVHD.
  • Drug: Basiliximab
    20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.

Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Acute Grade II-IV GVHD [ Time Frame: until 30 days after stem cell transplant ]
    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 :
  1. 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 ]
  2. Number of Days for Absolute Neutrophil Count to Recover [ Time Frame: From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion) ]
    Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days).

  3. Time to Resolution of Cytopenias: Platelet Transfusion Independence [ Time Frame: From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion) ]
    Average number of days per patient for resolution of cytopenias.

  4. Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria. [ Time Frame: up to 2 years after stem cell transplant ]
    Number of patients who died due to transplant related toxicities


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594308


Locations
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United States, Indiana
Indiana Universtiy Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Robert Nelson, MD Indiana Universtiy School of Medicine
More Information
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Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00594308    
Other Study ID Numbers: 0705-20 IUCRO-0196
First Posted: January 15, 2008    Key Record Dates
Results First Posted: March 20, 2012
Last Update Posted: October 6, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Multiple Myeloma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Lymphoma, Mantle-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Hodgkin Disease
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell
Myeloproliferative Disorders
Bone Marrow Diseases
Cyclosporine