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NCT01998880 · ClinicalTrials.gov registry record · Phase 3
CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 787
- Enrollment target
NCT01998880 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 787 participants.
The verdict
NCT01998880, 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 (1000mg 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 | 2009-12-22 |
| Est. Completion | 2017-08-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01998880
The ClinicalTrials.gov registry entry for NCT01998880 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.
NCT01998880 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01998880 about?
NCT01998880 is a clinical study titled "CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)". 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 NCT01998880?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 787 participants. The study started on 2009-12-22. Estimated completion is 2017-08-23.
What interventions are being tested in trial NCT01998880?
The interventions under investigation include: obinutuzumab (DRUG), rituximab (DRUG), chlorambucil (DRUG).
Who is sponsoring clinical trial NCT01998880?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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