CD19-specific T-cell for Chronic Lymphocytic Leukemia (CLL)
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.
Procedure: T-cell Infusion
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous CD19 Specific T-cell Infusion in Patients With B-cell Chronic Lymphocytic Leukemia (B-CLL)|
- Maximum Tolerated Dose (MTD) of CD19-specific T-cells [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Maximum tolerated dose (MTD) defined as the highest dose for which the posterior probability of toxicity is closest to 25%. Dose limiting toxicity (DLT) defined as new adverse events of grade 3+ (CTCAE version 4) involving cardiopulmonary, gastrointestinal, hepatic (excluding albumin), neurological, or renal parameters occurring with 6 weeks of infusion that are probably or definitely related to T-cell product. The maximum acceptable toxicity rate is 25%.
- Clinically Successful T-Cell Production [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]Clinically successful T-cell production defined as the amount of T-cells required for the dose level for which the patient is enrolled.
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: T-Cell Infusion + Chemotherapy
Peripheral blood mononuclear cells (PBMC) collected via venipuncture or steady state leukapheresis after enrollment. Clinically successful T-cell production defined as amount of T-cells required for dose level for which the patient is enrolled. Fludarabine 25 mg/m2 by vein on Days -5 to Day -3. Cyclophosphamide 250 mg/kg by vein on Days -5 to -3. Beginning dose of genetically modified cells is > 5x10^7/m2 but less than or equal to 5 x10^8/m2 infused on Day 0.
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.Drug: Fludarabine
25 mg/m2 by vein on Days -5 to Day -3.
Other Names:Drug: Cyclophosphamide
250 mg/kg by vein on Days -5 to -3.
Other Names:Procedure: T-cell Infusion
Beginning dose of genetically modified cells is > 5x10^7/m2 but less than or equal to 5 x10^8/m2 infused on Day 0.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653717
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Chitra M. Hosing, MD||M.D. Anderson Cancer Center|