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NCT03121001 · ClinicalTrials.gov registry record · Phase 2
Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease
A Phase 2 study of Sickle Cell Disease, sponsored by University of Illinois at Chicago.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03121001: Recruiting Phase 2 study of Sickle Cell Disease, sponsored by University of Illinois at Chicago.
NCT03121001 is a Phase 2 study of Sickle Cell Disease that is actively recruiting participants, run by University of Illinois at Chicago. The registered enrollment target is 50 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03121001, a Phase 2 study of Sickle Cell Disease, is actively recruiting participants, sponsored by University of Illinois at Chicago.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is a Phase II clinical trial. Patients will receive intensity modulated total body irradiation (TBI) at a dose of 3 Gy with standard fludarabine/ i.v. cyclophosphamide conditioning prior to human leukocyte antigen (HLA)-haploidentical hematopoietic stem cell transplant (HSCT). The primary objective of the study is to determine the engraftment at Day +60 following HLA-haploidentical hematopoietic stem cell transplant protocol using immunosuppressive agents and low-dose total body irradiation (TBI) for conditioning and post-transplant cyclophosphamide in patients with sickle cell disease.
Primary Outcome
Patients who achieve \< 5% peripheral blood donor chimerism by Day +30 and do not have a Day +60 measure will be regarded as failing to achieve full donor chimerism by Day +60; patients who achieve \> 5% donor chimerism by Day +30 but do not have a Day +60 measure will be considered nonevaluable for the primary endpoint.
Conditions Studied
Interventions
- RADIATION Total body irradiation
- DRUG ATG
- DRUG fludarabine
- DRUG cyclophosphamide
- PROCEDURE Stem cell infusion
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT03121001 shows while recruiting
NCT03121001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 5 interventions - of which Total body irradiation is the first listed.
NCT03121001 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03121001 about?
NCT03121001 is a clinical study titled "Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease". The study is a Phase II clinical trial. Patients will receive intensity modulated total body irradiation (TBI) at a dose of 3 Gy with standard fludarabine/ i.v. cyclophosphamide conditioning prior to human leukocyte antigen (HLA)-haploidentical hematopoietic stem cell transplant (HSCT). The primary...
What is the current status of trial NCT03121001?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2017-03-20. Estimated completion is 2026-05.
What conditions does trial NCT03121001 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT03121001?
The interventions under investigation include: Total body irradiation (RADIATION), ATG (DRUG), fludarabine (DRUG), cyclophosphamide (DRUG), Stem cell infusion (PROCEDURE).
Who is sponsoring clinical trial NCT03121001?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03121001 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03121001's enrollment target sits among peer trials
50 106th of 213 higher than 100 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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