In-Vivo Activated T-Cell Depletion to Prevent GVHD

NCT00594308 | Terminated Results DMC

• 1 other identifier: 0705-20 IUCRO-0196
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• Number of Days for Absolute Neutrophil Count to Recover

  From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)

• Time to Resolution of Cytopenias: Platelet Transfusion Independence

  From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)

• Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.

  up to 2 years after stem cell transplant

Interventions

Cyclophosphamide DRUG

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

Fludarabine DRUG

25mg/m2/day for 5 consecutive days

Cyclosporine DRUG

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

Mycophenolate mofetil DRUG

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

Basiliximab DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana Universtiy Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphocytic, Chronic, B-Cell; Anemia, Refractory, with Excess of Blasts; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Hodgkin Disease; Multiple Myeloma; Primary Myelofibrosis

Interventions

Cyclophosphamide; fludarabine; Cyclosporine; Mycophenolic Acid; Basiliximab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Limitations and Caveats

Four patients experienced grade 3-4 GVHD and this study was stopped.

Results Point of Contact

• Title: Robert Nelson, MD
• Organization: Indiana University School of Medicine

ronelson@iupui.edu

317-278-6871

Study Officials

• Robert Nelson, MD

  Indiana Universtiy School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 15, 2008
• Study Start: October 1, 2007
• Primary Completion: October 1, 2008
• Last Updated: October 6, 2014
• Results First Posted: March 20, 2012

Record last verified: 2014-09

Locations

US (1)