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Immune Reconstitution Following Campath Based Therapy
This study is ongoing, but not recruiting participants.

First Received on March 24, 2009.   Last Updated on October 31, 2011   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by (Responsible Party): M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00870090
  Purpose

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 chronic lymphocytic leukemia (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.


Condition Intervention Phase
Leukemia
Chronic Lymphocytic Leukemia
Other: T-Cell Infusion
Phase I

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 M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Success Rate (achievement of target activated T-cell dose of 1x10^10 +/- 20%) [ Time Frame: Day +90 after the co-stimulated T cell infusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2009
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Costimulated T-Cell Infusion Other: T-Cell Infusion
Intravenous infusion of co-stimulated T-cells at a dose of approximately 1 x 10^10 taking 10-30 minutes post chemo-immunotherapy.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870090

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00870090     History of Changes
Other Study ID Numbers: 2008-0210
Study First Received: March 24, 2009
Last Updated: October 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
T cell therapy
Chronic Lymphocytic Leukemia
CLL
Immune Reconstitution
CD3/CD28 bead activated T-cells
T-Cells
Immune Cells
Leukapheresis

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 February 09, 2012