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

Completed · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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).

Key facts

Study ID

NCT01013441

Run by

University of Pennsylvania

People needed

20

Starts

2009-03-01

Expected to finish

2018-12-01

Last updated by the study team

2019-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Abramson Cancer Center, University of Pennsylvania — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center, University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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