Personalized Natural Killer (NK) Cell Therapy in Cord Blood Transplantation (CBT) | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02727803

Personalized Natural Killer (NK) Cell Therapy in Cord Blood Transplantation (CBT)
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 learn if giving cells called natural killer (NK) cells after receiving 1 of 3 pre-treatment plans and a UCB transplant can improve response in participants with MDS, leukemia, lymphoma, or MM. The safety of this treatment and whether NK cells can lessen the risk of graft versus host disease (GVHD) will also be studied.

If the disease is CD20 positive, participant will also receive rituximab on this study in addition to what is described above. CD20 is a type of marker for white blood cells. White blood cells help protect the body from infections.

NK cells may kill cancer cells that remain in participant's body after their last chemotherapy treatment. The NK cells will be separated from umbilical cord blood. The device used in the laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will then be grown in the lab to increase the number of NK cells that can be given to participant by vein.

Status: 
Recruiting
Study Date: 
Sun, 05/01/2016 to Fri, 05/01/2020
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: Busulfan Busulfan 32 mg/m2 by vein test dose administrated either as an outpatient before Day -14 or as an inpatient on Day -9. Busulfan pharmacokinetics performed. Doses of days -7 to -4 subsequently adjusted to target an area under curve (AUC) of 4,000 microMol.min-1. In the event that PK adjusting was not possible a dose of busulfan of 130 mg/m2 administered. Other Names: Busulfex Myleran Drug: Fludarabine Treatment Plan #1: 10 mg/m2 by vein on Days -7 to -4. Participants </= 2 years of age receive Fludarabine 1.3 mg/kg. Treatment Plan # 2: 40 mg/m2 by vein on Days -6 to -3. Treatment Plan # 3: 40 mg/m2 by vein on Days -5 to -2. Other Names: Fludarabine phosphate Fludara Drug: Clofarabine 30 mg/m2 by vein on Days -7 to -4. Other Names: Clofarex Clolar Drug: Rabbit ATG Treatment Plan # 1 + Treatment Plan # 2: 1.25 mg by vein on Day -4 and 1.75 mg by vein on Day -3. Treatment Plan # 3: 1.25 mg by vein on Day -3 and 1.75 mg by vein on Day -2. Other Names: ATG (Rabbit) Rabbit Antithymocyte Globulin Rabbit Antilymphocyte Globulin rATG Thymoglobulin Radiation: Total Body Irradiation (TBI) Treatment Plan #1: TBI 2 Gy in AM on Day -3. Treatment Plan #2: TBI 2 Gy on Day -1. Other Names: Radiation Therapy XRT Procedure: Cord Blood Infusions Cord blood infusions on Day 0. Drug: Rituximab 375 mg/m2 by vein on Day -9 for participants with CD20+ malignancies. Other Name: Rituxan Drug: Cyclophosphamide 50 mg/kg by vein on Day -6. Other Names: Cytoxan Neosar Procedure: Natural Killer Cell Infusion NK Cell Infusion (C2C2 subgroup only) on Day +34. Drug: Melphalan 140 mg/m2 by vein on Day -2. For participants < 2 years of age: Melphalan 4.7 mg/kg. Other Name: Alkeran Drug: Mesna Mesna by vein on Day -6, after cyclophosphamide to help lower the risk of side effects to the bladder. Other Name: Mesnex