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NCT07585136 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Mobilization and Apheresis for Life-threatening Blood Disorders
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Not yet
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT07585136 is a Phase 1 study that has not yet begun recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 12 participants.
The verdict
NCT07585136, a Phase 1 study, has not yet begun recruiting, sponsored by St. Jude Children's Research Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate mobilization and collection of HSPCs in patients with bone marrow failure syndromes (BMFS) using granulocyte-colony stimulating factor (otherwise known as Filgrastim) with plerixafor to demonstrate safety and feasibility of collecting HSPCs to advance gene therapy. Primary objective: \- To characterize the safety of Filgrastim plus plerixafor in participants with bone marrow failure syndromes as determined by the incidence of adverse events (AEs). Secondary Objectives: * To characterize the feasibility of HSPC mobilization using Filgrastim plus plerixafor as determined by peripheral blood CD34+ counts. * To measure the mobilization effects of Filgrastim plus plerixafor in the peripheral blood in participants as determined by peak peripheral blood CD34+ counts. * To estimate efficacy of Filgrastim plus plerixafor for HSPC mobilization and apheresis collection in participants as determined by the yield of CD34+ cells (CD34+ cells/kg).
Interventions
- DRUG Plerixafor
- PROCEDURE Leukapheresis
- DRUG Filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07585136
The ClinicalTrials.gov registry entry for NCT07585136 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Plerixafor is the first listed.
NCT07585136 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07585136 about?
NCT07585136 is a clinical study titled "Stem Cell Mobilization and Apheresis for Life-threatening Blood Disorders". The purpose of this study is to investigate mobilization and collection of HSPCs in patients with bone marrow failure syndromes (BMFS) using granulocyte-colony stimulating factor (otherwise known as Filgrastim) with plerixafor to demonstrate safety and feasibility of collecting HSPCs to advance gene...
What is the current status of trial NCT07585136?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-06. Estimated completion is 2029-07-01.
What interventions are being tested in trial NCT07585136?
The interventions under investigation include: Plerixafor (DRUG), Leukapheresis (PROCEDURE), Filgrastim (DRUG).
Who is sponsoring clinical trial NCT07585136?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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