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NCT01203930 · ClinicalTrials.gov registry record · Phase 2
A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT01203930: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.
NCT01203930 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01203930, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL. This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.
Primary Outcome
ORR was assessed based on standardized International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria as specifically modified for this study to reflect current recommendations which consider the mechanism of action of idelalisib and similar drugs, and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. Based on the CLL response definition in the protocol (modified Hallek 2008), the parameters of lymp
Interventions
- DRUG Rituximab
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2010-10 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
Why NCT01203930 stopped before completion
NCT01203930 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01203930 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01203930 about?
NCT01203930 is a clinical study titled "A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL". This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL. This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demo...
What is the current status of trial NCT01203930?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2010-10. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01203930?
The interventions under investigation include: Rituximab (DRUG), Idelalisib (DRUG).
Who is sponsoring clinical trial NCT01203930?
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 NCT01203930's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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