CD34+ Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplant for Malignant Disease

About the study

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).

Study point of contact

Desmarie Sherwood
ds3851@cumc.columbia.edu
Jody Campbell, MPA
jc5422@cumc.columbia.edu

Locations

1 United States site

Age

< 22 Years

Phase

Phase 1/Phase 2

Study type

Interventional

Gender

All

Interventions

Device

Drug

Compensation

Unknown

participation requirements

General Eligibility (All Patients)

– Must be < 22 years of age - Diagnosed with a malignant disease - Must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent - For unrelated donor: A human leukocyte antigen (HLA) 8/10, 9/10 or 10/10 matched unrelated adult donor (MUD) will be required for study entry - For related donor: A 5/10, 6/10, 7/10, 8/10, 9/10 or 10/10 matched (or partially matched) family donor will be required for study entry - Adequate renal function - Adequate liver function - Adequate cardiac function - Adequate pulmonary function

participation restrictions

– Patients with documented uncontrolled infection at the time of study entry are not
eligible

– Females who are pregnant or breast feeding at the time of study entry are not eligible

Locations

  • New York, New York, United States, Columbia University Medical Center, 10032 [Recruiting]
Last updated 2020-06-17