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NCT02061800 · ClinicalTrials.gov registry record · Phase 1
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant
A Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Lymphoblastic Leukemia (ALL), sponsored by Diane George.
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02061800: Active Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Lymphoblastic Leukemia (ALL), sponsored by Diane George.
NCT02061800 is a Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Lymphoblastic Leukemia (ALL) that is active but no longer recruiting, run by Diane George. The registered enrollment target is 14 participants, below the 92-participant average among 17 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02061800, a Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Lymphoblastic Leukemia (ALL), is active but no longer recruiting, sponsored by Diane George.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study 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).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Alemtuzumab
- DRUG Thiotepa
- DRUG Tacrolimus
- DEVICE CliniMACS CD34+ Reagent System
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2013-06-03 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02061800
The ClinicalTrials.gov registry entry for NCT02061800 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 92-participant average among 17 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (85% lower). The listed sponsor is Diane George, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Myelodysplastic Syndrome (MDS) appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02061800 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02061800 about?
NCT02061800 is a clinical study titled "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 conditio...
What is the current status of trial NCT02061800?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2013-06-03. Estimated completion is 2026-07.
What conditions does trial NCT02061800 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome (MDS), Acute Lymphoblastic Leukemia (ALL), Chronic Myeloid Leukemia (CML), Acute Myelogenous Leukemia (AML), Juvenile Myelomonocytic Leukemia (JMML).
What interventions are being tested in trial NCT02061800?
The interventions under investigation include: Cyclophosphamide (DRUG), Alemtuzumab (DRUG), Thiotepa (DRUG), Tacrolimus (DRUG), CliniMACS CD34+ Reagent System (DEVICE).
Who is sponsoring clinical trial NCT02061800?
This trial is sponsored by Diane George, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02061800 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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