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NCT01585688 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of hLL1-DOX in Relapsed NHL and CLL
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01585688: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.
NCT01585688 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01585688, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary objectives are to evaluate the safety and tolerability of hLL1-DOX, and to determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated dosing schedule). The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies.
Primary Outcome
NCI CTCAE version 4.0 is used to grade all adverse events
Interventions
- DRUG hLL1-DOX (IMMU-115)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-08 |
| Est. Completion | 2017-10 |
| Phase | Phase 1 |
Why NCT01585688 stopped before completion
NCT01585688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which hLL1-DOX (IMMU-115) is the first listed.
NCT01585688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01585688 about?
NCT01585688 is a clinical study titled "Phase I/II Study of hLL1-DOX in Relapsed NHL and CLL". The primary objectives are to evaluate the safety and tolerability of hLL1-DOX, and to determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated dosing schedule). The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and i...
What is the current status of trial NCT01585688?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2012-08. Estimated completion is 2017-10.
What interventions are being tested in trial NCT01585688?
The interventions under investigation include: hLL1-DOX (IMMU-115) (DRUG).
Who is sponsoring clinical trial NCT01585688?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01585688's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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