CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02061800

CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This study is a research study involving subjects who are diagnosed with a malignant disease, that has either failed standard therapy or is unlikely to be cured with standard non-transplant therapy, who will receive a peripheral blood stem cell transplant. A malignant disease includes the following: Chronic Myeloid Leukemia (CML) in chronic phase, accelerated phase or blast crisis; Acute Myelogenous Leukemia (AML);Myelodysplastic Syndrome (MDS); Juvenile Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL); or Lymphoma (Hodgkin's and Non-Hodgkin's) The purpose of this study is to learn more about the effects of CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents and young adults. CD34+ stem cells are the cells that make all the types of blood cells in the body. GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes (a kind of white blood cell) against the recipient's body and organs. Study subjects will be offered treatment involving the use of a Miltenyi CliniMacs CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD.

Status: 
Recruiting
Study Date: 
Fri, 11/01/2013 to Fri, 12/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Device: CliniMACS CD34+ Reagent System The CliniMACS® Reagent System (Miltenyi Biotec, Bergisch Gladbach, Germany), is a semi-automated immunomagnetic cell selection medical device that is used in vitro to select and enrich specific cell populations in a closed, sterile environment. The system is comprised of a computer controlled medical device containing a permanent magnet, a closed-system sterile tubing set containing columns coated with a ferromagnetic matrix, and a magnetic cell specific labeling reagent. Drug: Thiotepa Thiotepa should be diluted in NS (1-5 mg/ml) and infused over 2 hrs on Days -5, -4. IV fluids should be at maintenance rate (1500 ml/m2). It is recommended that total parental nutrition not be used during Thiotepa administration as amino acid infusions may interfere with Thiotepa metabolism. Other Name: Thioplex Drug: Cyclophosphamide Cyclophosphamide (Cytoxan) should be infused over one hour. The drug can be diluted in D5W, NS, or other solutions (250cc) to a maximum concentration of 20 mg/mL. Other Names: Cytoxan CTX Drug: Alemtuzumab Each dose of alemtuzumab is to be diluted in D5W or NS (maximum concentration: 0.3 mg/mL) for IV infusion over two hours. Other Name: Campath Drug: Tacrolimus Tacrolimus dosing will be 0.03mg/kg/24 hours as continuous IV infusion or 0.12 mg/kg/day po divided Q8-12 hr Other Names: Prograf FK506 Drug: Melphalan Melphalan 45mg/m2 (1.5 mg/kg IV for children <1 year of age or <10 kg) diluted in 0.9% NS to a concentration of 0.1- 0.45mg/ml, given IV over 30 minutes. Other Name: Alkeran Drug: Busulfan (Busulfex) will be given IV in 0.9% sodium chloride or D5W to a final solution for infusion equal to 10 times the volume of diluent to Busulfex (to a concentration >0.5 mg/mL), through a central venous access device over 2 hours. Other Name: Busulfex Drug: Fludarabine Fludarabine will be given IV in 50-100 ml of D5W or 0.9% sodium chloride, over 30 minutes. Other Name: Fludara Drug: Methylprednisolone Methylprednisolone will be give IV slow infusion over 15-30 minutes. Other Name: Solu-Medrol