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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2028
  • participants needed
    15
  • sponsor
    Diane George
Updated on 1 November 2021
chronic myeloid leukemia
graft versus host disease
myeloid leukemia
lymphoid leukemia
fludarabine
tacrolimus
blast crisis
blood stem cell transplant
cyclophosphamide
lymphoma
busulfan
hodgkin's disease
melphalan
leukemia
lymphocytic leukemia
thiotepa
prednisolone
blast cells
myelomonocytic leukemia

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).

Description

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.

Details
Condition Chronic Myeloid Leukemia, acute lymphoid leukaemia, Lymphoproliferative disorders, Acute Myeloid Leukemia, acute myeloblastic leukemia, Juvenile Myelomonocytic Leukemia, myelodysplastic syndromes, acute myelogenous leukemia, Lymphoproliferative Disorder, lymphomas, Myelodysplastic Syndromes (MDS), Non-Hodgkin's Lymphoma, Chronic myeloid leukemia, MYELODYSPLASTIC SYNDROME, Lymphoma, Acute Myelogenous Leukemia (AML), Bone marrow disorder, myelodysplastic syndrome (mds), chronic myelogenous leukemia, acute lymphocytic leukemia, Acute myeloid leukemia, Lymphocytic Leukemia, Acute, anll, acute lymphoblastic leukemia, Bone Marrow Disorder, childhood ALL, leukemia, acute lymphoblastic, Preleukemia, acute lymphoblastic leukemia (all)
Treatment cyclophosphamide, busulfan, melphalan, Fludarabine, Tacrolimus, Methylprednisolone, alemtuzumab, thiotepa, CliniMACS CD34+ Reagent System
Clinical Study IdentifierNCT02061800
SponsorDiane George
Last Modified on1 November 2021

Eligibility

Yes No Not Sure

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
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