Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

NCT00975975 | Completed Phase 2 Results DMC

• 1 other identifier: 0908-04; IUCRO-0256
• Study Type: interventional
• Target: 17
• 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 (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.

Conditions

Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Myelodysplasia; Non-Hodgkin's Lymphoma; Hodgkin's Disease; Multiple Myeloma; Myelofibrosis; Anemia, Aplastic; Hemoglobinuria, Paroxysmal

Keywords

Paroxysmal nocturnal hemoglobinuria; severe aplastic anemia; Mantle cell

Outcome Measures

Primary Outcomes (1)

• Grade 3-4 Acute GVHD Rate

  The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD

  Transplant (Day 0) up to 1 year

Secondary Outcomes (2)

• Time to Neutrophil Engraftment

  Transplant (Day 0) up to 1 year

• Time to Platelet Engraftment

  Transplant (Day 0) up to 1 year

Study Arms (1)

Basiliximab

EXPERIMENTAL

Basiliximab will be given by IV on Day +7 post transplant for recipients of matched unrelated cells. Basiliximab will be given by IV on Day +9 post transplant for recipients of matched related cells.

Drug: Basiliximab

Interventions

Basiliximab DRUG

Basiliximab given 1 time on Day +7 or Day +9.

Also known as: Simulect

Basiliximab

Eligibility Criteria

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

You may qualify if:

• Acute myelogenous leukemia:
• Second or subsequent remission; patient over 18 yrs of age.
• Relapsed after autologous HC transplant, over 18 years of age.
• First remission, Philadelphia chromosome + over age 18.
• Secondary AML, in first or subsequent remissions.
• Acute lymphocytic leukemia:
• Philadelphia chromosome + over the age of 50, first or subsequent remission.
• Relapse following Autologous HC transplantation, ages over 50.
• Second or subsequent remission over the age of 50
• Chronic myelogenous leukemia:
• First or second chronic phase over the age of 18.
• Accelerated phase over the age of 18.
• Must have failed or been intolerant to a standard tyrosine kinase inhibitor.
• Chronic lymphocytic leukemia:
• Failed nucleoside-based therapy, ages \>18.

You may not qualify if:

• Active CNS disease (the presence of leukemic blasts in the CSF)
• Pregnancy or breast-feeding.
• Inability to give informed consent.
• AST, ALT, total bilirubin \>3x upper limit of normal.
• Creatinine \> 2 or creatinine clearance \< 50mL/hr. If patient has a creatinine of \> 2 or creatinine clearance \< 50mL/hr and it is due to the disease process then the patient will not be excluded based on this.
• Fractional shortening by echocardiogram not within normal limits per institution or LVEF of \< 40 %.
• Pulmonary function: DLCO not within institutional normal limits or DLCO less than 45% of normal predicted, corrected for anemia
• Prior allogeneic transplant.

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University 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; Hodgkin Disease; Multiple Myeloma; Primary Myelofibrosis; Anemia, Aplastic; Hemoglobinuria, Paroxysmal

Interventions

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; Bone Marrow Failure Disorders; Anemia, Hemolytic

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Robert Nelson
• Organization: IndianaU

ronelson@iu.edu

317-944-0920

Study Officials

• Robert Nelson, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2013
• Last Updated: February 26, 2016
• Results First Posted: February 26, 2016

Record last verified: 2016-01

Locations

US (1)