Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL)
Summary
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. Primary Objectives: · 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). Secondary Objectives: * 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.
Timeline
- Start
- 2009-07
- Primary completion
- 2012-05
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epratuzumab | Monoclonal antibody | 360 mg/m2 | Intravenous |
| Subject | aldesleukin | Protein / enzyme biologic | — | Subcutaneous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 12 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |