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NCT00914628 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia
A Phase 3 study, sponsored by AGC Biologics S.p.A..
- Terminated
- Registry status
- Phase 3
- Development phase
- 92
- Enrollment target
NCT00914628: Clinical Trial Phase 3 study, sponsored by AGC Biologics S.p.A..
NCT00914628 is a Phase 3 study that was terminated before completion, run by AGC Biologics S.p.A.. The registered enrollment target is 92 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00914628, a Phase 3 study, was terminated before completion, sponsored by AGC Biologics S.p.A..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 92 participants
- Enrollment target
Study Summary
The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT
Primary Outcome
Defined as the measure from the date of randomization until the date of relapse (or progression), or death from any cause, whichever occurs first. Disease relapse or progression was determined by the Investigator based on the following disease examination: * Morphology (bone marrow or peripheral blood) * Confirmation of mixed or full chimerism (evaluation of the degree of chimerism between donor/host, according to institutional clinical practice, on bone marrow or peripheral blood) * Cytogenet
Interventions
- GENETIC HSV-Tk
- OTHER T-cell depleted or T-cell replete strategies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2010-04-12 |
| Est. Completion | 2019-11-30 |
| Phase | Phase 3 |
Why NCT00914628 stopped before completion
NCT00914628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which HSV-Tk is the first listed.
NCT00914628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00914628 about?
NCT00914628 is a clinical study titled "Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia". The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT
What is the current status of trial NCT00914628?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 92 participants. The study started on 2010-04-12. Estimated completion is 2019-11-30.
What interventions are being tested in trial NCT00914628?
The interventions under investigation include: HSV-Tk (GENETIC), T-cell depleted or T-cell replete strategies (OTHER).
Who is sponsoring clinical trial NCT00914628?
This trial is sponsored by AGC Biologics S.p.A., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00914628's enrollment target sits among peer trials
92 1723rd of 2000 higher than 277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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