Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 105 participants.
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.
Interventions
- DRUG Rituximab
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2010-10 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01203930
The ClinicalTrials.gov registry entry for NCT01203930 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01203930 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.