CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01013441
First received: November 5, 2009
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

The purpose of this research study is to test whether giving T-cells (type of white blood cell that are also known as immune cells) that have been specially processed in the laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system return to normal faster after chemotherapy. This research study will also look into the ability of the lab to process the T-cells for infusion and the side effects of giving T-cells to patients with chronic lymphocytic leukemia (CLL).


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Biological: Infusion of CD3/CD28 stimulated T cells
Phase 1
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: Trial of Immune Reconstitution With CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The occurrence of treatment-related adverse events or treatment related trial discontinuations, defined as NCI CTC ≥ grade 3 and clinical events that are possible, likely, or definitely related to study treatment at any time [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • The ability to complete the outlined course of therapy [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • The ability to harvest, expand, and reinfuse autologous T cells in this target population of patients [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Infusion of CD3/CD28 stimulated T cells
    Receive CD3/CD28 stimulated T cells after fludarabine or alemtuzumab based chemotherapy
    Other Names:
    • Activated T cells
    • CD3/CD28 stimulated T cells
    • T cells
Detailed Description:

Single arm, multi-center trial to evaluate the efficacy of administering CD3/CD28 stimulated T cells to chronic lymphocytic leukemia (CLL) patients following treatment with fludarabine or alemtuzumab based chemo- immunotherapy. All patients will undergo an apheresis to collect peripheral blood mononuclear cells (PBMCs) for generation of expanded T cells post- chemo-immunotherapy. Those subjects who achieve a complete or partial response to the chemoimmunotherapy based regimen will receive an infusion of 1.0 x 1010 (+/- 20%) activated autologous T cells expanded from the collected apheresis unit. Prior to T-cell infusion, at Day +30, +60, and +365 after T cell infusion, blood draws will be performed to assess immune reconstitution and immune function as compared to baseline.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow.
  • Patients with Rai stage III-IV - OR - Patients with Rai stage 0-II
  • Zubrod performance status of 0-3
  • Prior treatment with fludarabine or alemtuzumab based regimens.
  • No untreated or uncontrolled life-threatening infection
  • Women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study
  • No active CNS disease
  • Negative tests for HIV antibodies, Hepatitis B surface antigen, and hepatitis C antibodies.

Exclusion Criteria:

  • Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration
  • History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g.

idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013441

Locations
United States, Pennsylvania
Abramson Cancer Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
MD Anderson Cancer Center, University of Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Pennsylvania
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Stephen J Schuster, MD Abramson Cancer Center, University of Pennsylvania
Principal Investigator: Chitra Hosing, MD MD Anderson Cancer Center, University of Texas
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01013441     History of Changes
Obsolete Identifiers: NCT00870090
Other Study ID Numbers: UPCC 15408
Study First Received: November 5, 2009
Last Updated: January 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014