CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 7 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 4, 2024 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Diane George
- Interventions being studied
- Device: CliniMACS CD34+ Reagent System; Drug: Thiotepa; Drug: Cyclophosphamide; Drug: Alemtuzumab; Drug: Tacrolimus; Drug: Melphalan; Drug: Busulfan; Drug: Fludarabine; Drug: Methylprednisolone
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Columbia University Irving Medical CenterNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 4, 2024. Always confirm current availability with the study team.