NCT01653717

Autologous CD19 Specific T-cell Infusion in Patients With B-cell Chronic Lymphocytic Leukemia (B-CLL)

Study Summary

The goal of this clinical research study is to find the highest tolerable dose of T cells that can be given in combination with standard chemotherapy to patients with CLL. The safety of this combination will also be studied. The T cells being used in this study are a type of white blood cell that will be taken from your blood and then genetically changed in a laboratory. The process of changing the DNA (the genetic material of cells) of the T cells is called a gene transfer. After the gene transfer is complete, the genetically changed T-cells will be put back into your body. These T cells may help prevent cancer cells from coming back.

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Interventions

LeukapheresisPROCEDURE
Blood drawn through a needle in a vein in one arm, then passed though a machine to collect white blood cells, and then remaining blood returned back to patient through a needle in a vein in other arm. Procedure will take about 3 hours to complete.
FludarabineDRUG
25 mg/m2 by vein on Days -5 to Day -3.
CyclophosphamideDRUG
250 mg/kg by vein on Days -5 to -3.
T-cell InfusionPROCEDURE
Beginning dose of genetically modified cells is \> 5x10\^7/m2 but less than or equal to 5 x10\^8/m2 infused on Day 0.

Study Locations

FacilityCityStateCountry
University of Texas MD Anderson Cancer CenterHoustonTexasUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026