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NCT02675959 · ClinicalTrials.gov registry record · Phase 2

Myeloablative Conditioning, Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell Disease

A Phase 2 study of Sickle Cell Disease, sponsored by New York Medical College.

Recruiting
Registry status
Phase 2
Development phase
40
Enrollment target
4
Study locations

NCT02675959 is a Phase 2 study of Sickle Cell Disease that is actively recruiting participants, run by New York Medical College. The registered enrollment target is 40 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (86% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT02675959, a Phase 2 study of Sickle Cell Disease, is actively recruiting participants, sponsored by New York Medical College.

RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
4
Study locations

Study Summary

This is a follow-up trial to NYMC 526 (NCT01461837) to assess the safety, efficacy and toxicity of administering Defibrotide prophylaxis for high-risk sickle cell or beta thalassemia patients undergoing a familial haploidentical allogeneic stem cell transplantation with CD34 enrichment and T-cell addback. This patient population historically has a risk of developing sinusoidal obstructive syndrome (SOS) and Defibrotide has demonstrated efficacy in treatment of SOS. The Funding Source is FDA OOPD.

Conditions Studied

Interventions

  • DRUG Defibrotide

Study Locations (4)

California

  • University of California Los Angeles - Los Angeles

Florida

  • University of Florida - Gainesville

New York

  • New York Medical College - Valhalla

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-07-01
Est. Completion 2027-12
Phase Phase 2

Sponsor

New York Medical College

47 total trials

What the Registry Record Tells You About NCT02675959

The ClinicalTrials.gov registry entry for NCT02675959 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (86% lower). The listed sponsor is New York Medical College, which has 47 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Defibrotide is the first listed.

NCT02675959 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT02675959 about?

NCT02675959 is a clinical study titled "Myeloablative Conditioning, Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell Disease". This is a follow-up trial to NYMC 526 (NCT01461837) to assess the safety, efficacy and toxicity of administering Defibrotide prophylaxis for high-risk sickle cell or beta thalassemia patients undergoing a familial haploidentical allogeneic stem cell transplantation with CD34 enrichment and T-cell ad...

What is the current status of trial NCT02675959?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-07-01. Estimated completion is 2027-12.

What conditions does trial NCT02675959 study?

This clinical trial studies the following conditions: Sickle Cell Disease.

What interventions are being tested in trial NCT02675959?

The interventions under investigation include: Defibrotide (DRUG).

Who is sponsoring clinical trial NCT02675959?

This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02675959 being conducted?

This trial has 4 study locations across California, Florida, New York, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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