In-Vivo Activated T-Cell Depletion to Prevent GVHD

This study has been terminated.
(Treatment ineffective)
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00594308
First received: January 4, 2008
Last updated: September 26, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In-Vivo Activated T-Cell Depletion to Prevent GVHD

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00594308     History of Changes
Other Study ID Numbers: 0705-20 IUCRO-0196
Study First Received: January 4, 2008
Results First Received: August 5, 2011
Last Updated: September 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Multiple Myeloma
Myelodysplastic Syndromes
Neoplasms, Plasma Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Preleukemia
Primary Myelofibrosis
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 30, 2014