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NCT02053610 · ClinicalTrials.gov registry record · Phase 3
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 787
- Enrollment target
NCT02053610 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 787 participants.
The verdict
NCT02053610, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 787 participants
- Enrollment target
Study Summary
This open-label, randomized, 3-arm study will evaluate the efficacy and safety of (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m\^2 cycle 1, 500 mg/m\^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is \>6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.
Interventions
- DRUG obinutuzumab
- DRUG rituximab
- DRUG chlorambucil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 787 participants |
| Start Date | 2009-12-31 |
| Est. Completion | 2017-08-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02053610
The ClinicalTrials.gov registry entry for NCT02053610 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 787 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which obinutuzumab is the first listed.
NCT02053610 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02053610 about?
NCT02053610 is a clinical study titled "CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)". This open-label, randomized, 3-arm study will evaluate the efficacy and safety of (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be rand...
What is the current status of trial NCT02053610?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 787 participants. The study started on 2009-12-31. Estimated completion is 2017-08-23.
What interventions are being tested in trial NCT02053610?
The interventions under investigation include: obinutuzumab (DRUG), rituximab (DRUG), chlorambucil (DRUG).
Who is sponsoring clinical trial NCT02053610?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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