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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: Recruiting Phase 2 study of Sickle Cell Disease, sponsored by New York Medical College.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients will be given Defibrotide prophylaxis starting 10 days before the stem cell infusion at 6.25 mg/kg IV q6h and continue through Day +21.
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT02675959 shows while recruiting
NCT02675959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02675959's enrollment target sits among peer trials
40 124th of 213 higher than 86 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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.
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