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

January 28, 2016 updated by: Indiana University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Simulect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade 3-4 Acute GVHD Rate
Time Frame: Transplant (Day 0) up to 1 year
The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD
Transplant (Day 0) up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Neutrophil Engraftment
Time Frame: Transplant (Day 0) up to 1 year
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Transplant (Day 0) up to 1 year
Time to Platelet Engraftment
Time Frame: Transplant (Day 0) up to 1 year
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Transplant (Day 0) up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Investigators

  • Principal Investigator: Robert Nelson, MD, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (ESTIMATE)

September 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0908-04; IUCRO-0256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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