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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 85-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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).

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

FieldValue
Enrollment Target 14 participants
Start Date 2013-06-03
Est. Completion 2026-07
Phase Phase 1
Diane George

2 total trials

What the registry record for NCT02061800 still lists

NCT02061800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 85-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (84% lower).

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 a single indexed study location in 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.

Similar trials for Myelodysplastic Syndrome (MDS)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02061800's enrollment target sits among peer trials

14 17th of 19 higher than 3 of 19 other Myelodysplastic Syndrome (MDS) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Myelodysplastic Syndrome (MDS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02061800, the US trial registry maintained by the National Library of Medicine. NCT02061800 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.