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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013441
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : October 23, 2019
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Biological: Infusion of CD3/CD28 stimulated T cells Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2009
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Arm 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

Primary Outcome Measures :
  1. 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 ]
  2. The ability to complete the outlined course of therapy [ Time Frame: Two years ]
  3. The ability to harvest, expand, and reinfuse autologous T cells in this target population of patients [ Time Frame: Two years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01013441

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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
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Principal Investigator: Stephen J Schuster, MD Abramson Cancer Center, University of Pennsylvania
Principal Investigator: Chitra Hosing, MD MD Anderson Cancer Center University of Texas
Additional Information:
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Responsible Party: University of Pennsylvania Identifier: NCT01013441    
Obsolete Identifiers: NCT00870090
Other Study ID Numbers: UPCC 15408
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Keywords provided by University of Pennsylvania:
Chronic Lymphocytic Leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell