drugset / Trial / NCT02061800

CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant

NCT02061800

Phase 1/2 Active not recruiting 14 enrolled Diane George
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to learn more about the effects of (classification determinant) 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 the CliniMACS® Reagent System (Miltenyi Biotec), a 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. This study involves 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).

Timeline

Start
2013-06-03
Primary completion
2026-07
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody Intravenous
Subject Busulfan Small molecule Intravenous
Comparator Cyclophosphamide Other / unclassified Intravenous
Subject Fludarabine Small molecule Intravenous
Subject Melphalan Small molecule 1.5 mg/kg Intravenous
Subject Melphalan Small molecule 45 mg/m2 Intravenous
Subject Methylprednisolone Other / unclassified Intravenous
Subject Tacrolimus Small molecule 0.03 mg/kg Intravenous
Subject Tacrolimus Small molecule 0.12 mg/kg Intravenous
Comparator Thiotepa Other / unclassified Intravenous