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NCT01625351 · ClinicalTrials.gov registry record · Phase 1
A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT01625351: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT01625351 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625351, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. This strategy, which includes selective depletion of naïve T cells, may speed immune reconstitution thereby potentially reducing the limitations of traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its potential therapeutic application. Additionally, the investigators intend to explore overall survival, event-free survival, hematopoietic cell recovery and engraftment as well as infection rates and complications in these patients.
Primary Outcome
Feasibility is defined as engraftment (ANC≥ 500/mm3 for 3 consecutive tests performed on different days) evaluated before day +30.
Interventions
- DRUG Busulfan
- DRUG fludarabine
- DRUG melphalan
- DRUG sirolimus
- DRUG alemtuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2012-08-20 |
| Est. Completion | 2020-02-10 |
| Phase | Phase 1 |
What the finished NCT01625351 record still lists
NCT01625351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Busulfan is the first listed.
NCT01625351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01625351 about?
NCT01625351 is a clinical study titled "A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas". This is a phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. This strategy, which includes selective depletion of naïve T cells, may speed immune reconsti...
What is the current status of trial NCT01625351?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2012-08-20. Estimated completion is 2020-02-10.
What interventions are being tested in trial NCT01625351?
The interventions under investigation include: Busulfan (DRUG), fludarabine (DRUG), melphalan (DRUG), sirolimus (DRUG), alemtuzumab (DRUG).
Who is sponsoring clinical trial NCT01625351?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01625351's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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