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NCT01966367 · ClinicalTrials.gov registry record · Phase 1

CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation

A Phase 1 study of Severe Aplastic Anemia and Diamond-Blackfan Anemia, sponsored by Diane George.

Active
Registry status
Phase 1
Development phase
37
Enrollment target
1
Study location

NCT01966367 is a Phase 1 study of Severe Aplastic Anemia and Diamond-Blackfan Anemia that is active but no longer recruiting, run by Diane George. The registered enrollment target is 37 participants, below the 124-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01966367, a Phase 1 study of Severe Aplastic Anemia and Diamond-Blackfan Anemia, is active but no longer recruiting, sponsored by Diane George.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
37 participants
Enrollment target
1
Study location

Study Summary

This study's goal is to determine the frequency and severity of acute graft versus host disease, to evaluate incidence of primary and secondary graft rejection, to assess event free survival and overall survival, to determine the time to neutrophil and platelet engraftment, to determine the time to immune reconstitution (including normalization of T, B and natural killer (NK) cell repertoire and Immunoglobulin G production), and to establish the incidence of infectious complications including bacterial, viral, fungal and atypical mycobacterial and other infections following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a non-malignant disease.

Conditions Studied

Severe Aplastic Anemia Diamond-Blackfan Anemia Bone Marrow Failure Syndrome Severe Congenital Neutropenia Amegakaryocytic Thrombocytopenia Schwachman Diamond Syndrome Primary Immunodeficiency Syndromes Acquired Immunodeficiency Syndromes Histiocytic Syndrome Familial Hemophagocytic Lymphocytosis

Interventions

  • BIOLOGICAL CD34 Stem Cell Selection Therapy

Study Locations (1)

New York

  • Morgan Stanley Children's Hospital, New York-Presbyterian, Columbia University - New York

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2013-03
Est. Completion 2030-02
Phase Phase 1

Sponsor

Diane George

2 total trials

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What the Registry Record Tells You About NCT01966367

The ClinicalTrials.gov registry entry for NCT01966367 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 124-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target (70% lower). The listed sponsor is Diane George, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Severe Aplastic Anemia appearing as the primary indexed condition, and to 1 intervention - of which CD34 Stem Cell Selection Therapy is the first listed.

NCT01966367 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01966367 about?

NCT01966367 is a clinical study titled "CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation". This study's goal is to determine the frequency and severity of acute graft versus host disease, to evaluate incidence of primary and secondary graft rejection, to assess event free survival and overall survival, to determine the time to neutrophil and platelet engraftment, to determine the time to ...

What is the current status of trial NCT01966367?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2013-03. Estimated completion is 2030-02.

What conditions does trial NCT01966367 study?

This clinical trial studies the following conditions: Severe Aplastic Anemia, Diamond-Blackfan Anemia, Bone Marrow Failure Syndrome, Severe Congenital Neutropenia, Amegakaryocytic Thrombocytopenia.

What interventions are being tested in trial NCT01966367?

The interventions under investigation include: CD34 Stem Cell Selection Therapy (BIOLOGICAL).

Who is sponsoring clinical trial NCT01966367?

This trial is sponsored by Diane George, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01966367 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.