Natural Killer (NK) Cells With HLA Compatible Hematopoietic Transplantation for High Risk Myeloid Malignancies | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01823198

Natural Killer (NK) Cells With HLA Compatible Hematopoietic Transplantation for High Risk Myeloid Malignancies
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The goal of this clinical research study is to find the highest tolerable dose of immune cells called natural killer (NK) cells that can be given with chemotherapy and a stem cell transplant to patients with AML and MDS. Researchers want to learn if adding NK cells will help make the stem cell transplant more effective in treating the disease. The safety of this treatment will also be studied.

NK cells may kill cancer cells that remain in your body after your last chemotherapy treatment. The NK cells will be separated from blood from a relative of yours or from umbilical cord blood. These separated NK cells will then be grown in the lab to increase the number of NK cells that can be given to you by vein.

The chemotherapy given on this study will consist of the following drugs:

  • Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants.
  • Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer cells to die.

IL-2 (interleukin-2) is a naturally occurring protein (cytokine) that can enhance NK cell function.

Status: 
Recruiting
Study Date: 
Sat, 06/01/2013 to Fri, 06/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Busulfan 32 mg/m2 test dose based on actual body weight given by vein within 2 weeks of the preparative regimen. Busulfan adjusted dose determined to achieve a systemic exposure represented by an average daily AUC of 6000 µMol-min ± 5% on Day -13 to Day -10. Patients over age 60 and/or with performance status =2 receive and AUC of 4000 microM x min for each dose. If it is not feasible to perform the pharmacokinetic studies, Busulfan dose of 130 mg/m2 administered (100 mg/m2 for age over 60 or PS=2). PK-guided daily high-dose Busulfan dose(s) started immediately upon completion of the daily fludarabine doses. Other Names: Busulfex Myleran Drug: Fludarabine 40 mg/m2 by vein dosed per actual body weight/actual body surface area on Day -13 to Day -10. Procedure: Alloreactive NK infusion Alloreactive NK cell infusion given by vein on Day -8 at one of 4 dose levels based on the number of NK cells (CD3-,CD 56+ cells)/kg recipient body weight. Dose levels are: 106, 107, 3 x 107, 108. Other Name: Immune cells Drug: Interleukin-2 0.5 million units subcutaneously on Day -8 to Day -4. Other Names: IL-2 Aldesleukin Proleukin Drug: Thymoglobulin 0.5 mg/kg by vein on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1. Other Names: Antithymocyte globulin ATG Procedure: Stem Cell Infusion Peripheral blood progenitor cells infused on Day 0 or on arrival of the unrelated donor cells. Drug: G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days. Other Names: Filgrastim Neupogen Drug: Tacrolimus Starting dose of 0.015 mg/kg as a 24 hour continuous infusion daily adjusted with a goal to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus is changed to oral dosing when tolerated and can be tapered off after Day +90 if no GvHD is present. Other Name: Prograf Drug: Methotrexate 5 mg/m2 administered intravenously on Days 1, 3, 6 and 11 post transplant.