In-Vivo Activated T-Cell Depletion to Prevent GVHD

Multiple Myeloma Clinical Trial

Official title:

In-Vivo Activated T-Cell Depletion to Prevent GVHD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00594308
• Other study ID #: 0705-20 IUCRO-0196
• Status: Terminated
• Phase: N/A
• First received: January 4, 2008
• Last updated: September 26, 2014
• Start date: October 2007

Study information

• Verified date: September 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Acute Myelogenous Leukemia
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Hodgkin Disease
• Hodgkin's 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
• Lymphoma, Non-Hodgkin's
• Mantle-Cell Lymphoma
• Multiple Myeloma
• Myelodysplasia
• Myelodysplastic Syndromes
• Myelofibrosis
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

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

Locations

Country	Name	City	State
United States	Indiana Universtiy Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

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