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NCT01300247 · ClinicalTrials.gov registry record · Phase 1
A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON)
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT01300247: Completed Phase 1 study, sponsored by Genentech.
NCT01300247 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01300247, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This open-label, 2-arm, nonrandomized, multicenter, Phase Ib study will investigate the safety and efficacy of obinutuzumab (RO5072759; GA101) administered in combination with chemotherapy (bendamustine or fludarabine + cyclophosphamide \[FC\] regimens) in participants with previously untreated cluster of differentiation 20 (CD20)-positive B-CLL. Participants will be enrolled to receive a maximum of 6 cycles of obinutuzumab (1000 milligrams \[mg\] intravenous \[IV\] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus bendamustine (90 milligrams per meter square \[mg/m\^2\] IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus FC (fludarabine 25 mg/m\^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2 - 6; cyclophosphamide 250 mg/m\^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2 - 6) on 28 day cycles.
Interventions
- DRUG Obinutuzumab
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01300247 record still lists
NCT01300247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 4 interventions - of which Obinutuzumab is the first listed.
NCT01300247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01300247 about?
NCT01300247 is a clinical study titled "A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON)". This open-label, 2-arm, nonrandomized, multicenter, Phase Ib study will investigate the safety and efficacy of obinutuzumab (RO5072759; GA101) administered in combination with chemotherapy (bendamustine or fludarabine + cyclophosphamide \[FC\] regimens) in participants with previously untreated clus...
What is the current status of trial NCT01300247?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2011-05. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01300247?
The interventions under investigation include: Obinutuzumab (DRUG), Cyclophosphamide (DRUG), Fludarabine (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01300247?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01300247's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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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