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In-Vivo Activated T-Cell Depletion to Prevent GVHD

This study has been terminated.

(Treatment ineffective)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00594308

First Posted: January 15, 2008

Last Update Posted: October 6, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Indiana University

Purpose

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	Intervention
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


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Multiple Myeloma Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myeloid Leukemia Myelofibrosis Chronic Myeloid Leukemia Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Mantle Cell Lymphoma Hodgkin Lymphoma Chronic Myeloproliferative Disorders

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

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:

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 [ 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).
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.
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


Enrollment:	10
Study Start Date:	October 2007
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

25mg/m2/day for 5 consecutive days

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

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

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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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

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


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

Sponsors and Collaborators

Indiana University

Investigators


Principal Investigator:	Robert Nelson, MD	Indiana Universtiy School of Medicine

More Information


Responsible Party:	Indiana University
ClinicalTrials.gov Identifier:	NCT00594308 History of Changes
Other Study ID Numbers:	0705-20 IUCRO-0196
First Submitted:	January 4, 2008
First Posted:	January 15, 2008
Results First Submitted:	August 5, 2011
Results First Posted:	March 20, 2012
Last Update Posted:	October 6, 2014
Last Verified:	September 2014

Additional relevant MeSH terms:


Lymphoma Leukemia Multiple Myeloma Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Myeloid Lymphoma, Mantle-Cell Leukemia, Myelogenous, Chronic, BCR-ABL Positive Primary Myelofibrosis Leukemia, Myeloid, Acute Hodgkin Disease Lymphoma, Non-Hodgkin Precursor Cell Lymphoblastic Leukemia-Lymphoma Myelodysplastic Syndromes Preleukemia	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

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