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

Study point of contact

Desmarie Sherwood
[email protected]
Jody Campbell, MPA
[email protected]

Locations

1 United States site

Age

< 22 Years

Phase

Phase 1/Phase 2

Study type

Interventional

Gender

All

Interventions

Device

Drug

Compensation

Unknown

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).

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]