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Study Summary
No. 2008-0210:.......Leukemia......Chitra M. Hosing......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2008-0210
Study Title:Trial of immune reconstitution with CD3/CD28 bead activated T-cells following chemo-immunotherapy in patients with chronic lymphocytic leukemia.
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Physician New Patient Referral
Name:Chitra M. HosingPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:CLL Global Research Foundation
Phase of Study:Phase IReturn
Visit:
Patients who receive alemtuzumab based therapy may have to come back every 2
weeks till the alemtuzumab levels become undetectable.
All patients will come back for follow up at 30, 90 days and 1 year after the
infusion of T cells.
Treatment
Agents:
T cell therapyHome Care:NA
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
NA
Description/
Intervention:
The goal of this clinical research study is to learn if giving T-cells (immune
cells) that have been specially processed in the laboratory will help CLL
patients' immune system recover faster after chemotherapy. This may help lower
the chance of infections. The safety of this treatment will also be studied.
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Study Objectives / Outcomes
Primary Objectives

1. To study the feasibility and safety of infusion of autologous CD3/CD28 bead-activated T-cells following fludarabine or alemtuzumab based chemo-immunotherapy in patients with chronic lymphocytic leukemia.

Secondary Objectives:

1. To study immune reconstitution in patients treated with infusion of autologous CD3/CD28 bead-activated T-cells.
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    Study Status Information
    Study Activation / Registration Date:03/20/2009
    IRB Review and Approval Date:07/10/2008
    Study Type:Phase Ii Or Phase I/Ii
    Recruitment Status:Closed
    Projected Accrual:20
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

    Inclusion Criteria:1) All patients must have a diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow.

    2) Patients with Rai stage III-IV - OR - Patients with Rai stage 0-II (Appendix D) who meet one or more indication for treatment as defined by the NCI-sponsored Working Group are eligible for treatment on this protocol.

    3) All patients must have a Zubrod performance status of 0-3 ( Appendix E )

    4) Patients must receive treatment with fludarabine or alemtuzumab based regimens.

    5) Patients must not have untreated or uncontrolled life-threatening infection.

    6) Patients must sign informed consent.

    7) 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.

    8) No active CNS disease

    9) Negative tests for HIV antibodies, Hepatitis B surface antigen, and Hepatitis C antibodies.

    Exclusion Criteria:1) 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.

    2) 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.

    3) Subject Recruitment and Accrual Accrual is anticipated to take 12-15 months at a recruitment rate of approximately 1 patient per site per month. The expectation is that each site will recruit 50% of the target of 20 total evaluable patients. Subjects will be identified through the clinical practices of the investigator or sub investigators in the Division of Stem Cell Transplantation and Cell Therapy at MD Anderson and Division of Hematology-Oncology at both MD Anderson and UPENN.

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    Links
    Registration Number: NCT01013441
    Study Information on Clinical Trials Registry (clinicaltrials.gov)

    Other Links:
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    Results


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