Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL)
The goal of this clinical research study is to learn if transferring the donor's NK cells, in combination with an antibody called epratuzumab and low-dose interleukin (IL-2), into your body can be done safely. Researchers want to find out if the infused NK cells will survive after the infusion and if the NK cell infusion helps to destroy cancer cells in the recipient's body and possibly to help control the disease.
· Evaluate the feasibility of collecting an adequate number of natural killer (NK) cells from a donor and evaluate the safety of a haploidentical donor-derived NK cell infusion, Epratuzumab, and low-dose interleukin-2 (IL-2).
- Quantification and persistence of the infused donor NK cell in vivo;
- Quantification and persistence of cytokine levels;
- Assessment of NK cell immunophenotype and function;
- Correlate above with anti-tumor effect.
Procedure: Infusion of NK cells
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adoptive Transfer of Haploidentical NK Cells in Combination With Epratuzumab for the Treatment of Relapsed Acute Lymphoblastic Leukemia|
- Time to Progression (TTP) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]TTP calculated as average time, in months, from baseline to participants disease progression or death, monitored for a minimum of 1 year
- Overall Survival (OS) [ Time Frame: Minimum of 1 year, or until disease progression or death ] [ Designated as safety issue: No ]Number of surviving participants without disease progression or death for any reason at one year post treatment.
|Study Start Date:||July 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Haploidentical NK cells + Epratuzumab
Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours. Mesna 12 mg/kg by vein 5 times per day on Days -5 and -4 over 15 minutes.
360 mg/m^2 once a day by vein on Day -4, Day -1 and Days 3, 6, 10, 13 and 17.Drug: Fludarabine
25 mg/m^2 once a day by vein on Day -6 through Day -2 over 30 minutes.
Other Names:Drug: Cyclophosphamide
60 mg/kg once a day by vein on Days -5 and -4 over 2 hours.
Other Names:Drug: Mesna
12 mg/kg by vein 5 times per day on Days -5 and -4 over 15 minutes.
Other Name: MesnexProcedure: Infusion of NK cells
Transplant of Haploidentical NK cells by vein on Day 0.
Other Names:Drug: Interleukin-2
Subcutaneous injections three times a week for 9 doses on Days 0 to 21.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00941928
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Anna Franklin, MD||UT MD Anderson Cancer Center|