CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any - 22 |
| Updated: | 3/15/2019 |
| Start Date: | June 3, 2013 |
| End Date: | December 2019 |
| Contact: | Jean Sosna, RN |
| Email: | js4403@columbia.edu |
| Phone: | 212-305-2050 |
CD34+ Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplant for Malignant Disease
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).
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).
Graft versus host disease (GVHD) is one of the serious complications following allogeneic
stem cell transplantation. The incidence and severity of GVHD increase with the degree of HLA
incompatibility between the host and donor. The most reliable way to prevent acute and
chronic GVHD is to remove T cells from the graft. However, the incidence of graft failure
increases with the efficiency of T cell depletion and low T cell numbers are predictive of
graft failure. Immunomagnetic selection of HLA-mismatched CD34+ progenitor cells has
demonstrated high levels of T cell depletion and successful engraftment in adult and
pediatric patients with the malignant and nonmalignant disease.
stem cell transplantation. The incidence and severity of GVHD increase with the degree of HLA
incompatibility between the host and donor. The most reliable way to prevent acute and
chronic GVHD is to remove T cells from the graft. However, the incidence of graft failure
increases with the efficiency of T cell depletion and low T cell numbers are predictive of
graft failure. Immunomagnetic selection of HLA-mismatched CD34+ progenitor cells has
demonstrated high levels of T cell depletion and successful engraftment in adult and
pediatric patients with the malignant and nonmalignant disease.
Inclusion Criteria: 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
Exclusion Criteria:
- 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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Diane George, MD
Phone: 212-305-2050
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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