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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00975975
First received: September 11, 2009
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
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
Drug: Basiliximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Assess the incidence grade 3-4 aGVHD; Compare the incidence of grade 3-4 aGVHD with those of a recently completed clinical trial cohort [ Time Frame: Pre-Transplant thru 1 year post transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To test the hypothesis that donor cell engraftment is associated with an expansion of donor-derived natural killer cells in the immediate post-transplant period [ Time Frame: Pre-transplant thru 1 year post-transplant ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: September 2009
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Basiliximab
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
Basiliximab given 1 time on Day +7 or Day +9.
Other Name: Simulect

Detailed Description:

This study is for patients with a blood condition or myelodysplasia (bone marrow disease) which has either not responded to treatment or is not treatable by conventional/routine medical treatments. Bone marrow transplantation is a medical treatment that involves giving high doses of chemotherapy followed by the transplantation of the blood-forming and immune cells from a relative or from a "matched" unrelated person through the National Marrow Donor Program, in an attempt to cure disease in the recipient (the person receiving the donated cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a relatively new technique in which lower than usual doses of chemotherapy are given before transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors have determined are beneficial for this condition.

This research is being done because the complication of graft-versus-host disease can be bad for a person and there is no completely safe and effective way to prevent this complication. We know that cyclosporine helps but would like to know if the addition of basiliximab, given with cyclosporine, will decrease the incidence and/or severity of graft-versus-host disease after a transplant known as nonmyeloablative or "mini" transplant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Myelodysplasia:

    • All-risk categories, age greater than 18.
  • Non-Hodgkin's Lymphoma, less than 76 years of age

    • Relapsed diffuse aggressive NHL (intermediate and high grade) that fails to achieve CR or PR to conventional salvage chemotherapy.
    • Aggressive NHL includes diffuse large B cell lymphoma, diffuse mixed small and large cell lymphoma, follicular lymphoma for grade 3 (follicular large cell lymphoma), T or B cell lymphoblastic lymphoma, diffuse small noncleaved (Burkett's or Burkett-like ) lymphoma, mantle cell lymphoma, peripheral T cell lymphoma, anaplastic large cell lymphoma, and other diffuse aggressive lymphomas that are not otherwise classifiable
    • Aggressive NHL that has relapsed following autologous HCT. Patients that respond to additional treatment for post-transplant relapse are eligible.
    • Aggressive NHL that does not achieve CR or PR with primary chemotherapy (i.e., primary induction failure).
    • Low-grade lymphoma refractory to standard therapy, including the following:

      1. small cell lymphocytic lymphoma,
      2. follicular lymphoma of grades 1 and 2 (follicular small cleaved and follicular mixed small and large cell lymphoma)
      3. marginal cell lymphoma, splenic lymphoma),
      4. lymphoplasmacytic lymphoma and
      5. other lymphomas not otherwise classifiable.
  • Patients with low-grade lymphoma must have experienced progressive disease after receiving three or more of the following regimens:

    • alkylator-based therapy (cyclophosphamide/ vincristine/ prednisone) chlorambucil, monoclonal antibody based therapy (e.g., rituximab, Campath-1H, radiolabelled CD20+ antibodies);
    • nucleoside analog-based therapy (e.g., fludarabine, cladribine).)
  • Patients with marginal zone lymphoma or gastric MALT type associated with Helicobacter pylori infection must have progressed after receiving appropriate antibiotic therapy as well as three or more regimens as described above
  • Mantle cell, ages 18-75.
  • Hodgkin's Disease, ages 18-75.

    • Relapsed or refractory disease after autologous transplant.
  • Multiple Myeloma, ages 18-75

    • Recurrent disease after two medical therapies
    • Relapse following autologous transplant
  • Myelofibrosis, age greater than 18 years
  • Severe aplastic anemia (refractory to immunosuppressive therapy); age greater than 18 years

    • Patients with aplastic anemia must have marrow cellularity ≤ 10% plus 2 of the following:

      1. Absolute granulocyte count <500/mm3
      2. Corrected reticulocyte count <1%
      3. Untransfused platelet count <20,000/mm3 on at least 2 occasions
      4. Hemoglobin <9 g/dL (adults) or < 8 g/dL (children) on at least 2 occasions
  • Paroxysmal nocturnal hemoglobinuria; age greater than 18 years.

    • Renal function: creatinine greater than 2.5
  • Donor Requirement:

    • Must have a fully HLA-matched (10 of 10 Antigen matched) 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975975

Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Robert Nelson, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00975975     History of Changes
Other Study ID Numbers: 0908-04; IUCRO-0256
Study First Received: September 11, 2009
Last Updated: October 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Paroxysmal nocturnal hemoglobinuria
severe aplastic anemia
Mantle cell

Additional relevant MeSH terms:
Primary Myelofibrosis
Anemia
Anemia, Aplastic
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Hematologic Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Anemia, Hemolytic
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 23, 2014