A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON)

ClinicalTrials.gov ID: NCT01300247

Public ClinicalTrials.gov record NCT01300247. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 2:24 AM EDT

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Official title

An Open-Label, Multicenter, Phase Ib Trial of GA101 (RO5072759) in Combination With Chemotherapy in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01300247
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Genentech, Inc.; Industry
Enrollment: 41 participants

Conditions and interventions

Conditions

Lymphocytic Leukemia, Chronic

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 30, 2011
Primary completion: Dec 31, 2012
Completion: Nov 30, 2015
Last update posted: Feb 1, 2017

2011 – 2015

United States locations

U.S. sites: 18
U.S. states: 14
U.S. cities: 18

Facility	City	State	ZIP	Site status
Not listed	Huntsville	Alabama	35805	—
Not listed	Duarte	California	91010	—
Not listed	La Jolla	California	92093	—
Not listed	Los Angeles	California	90095	—
Not listed	Southington	Connecticut	06489	—
Not listed	Tampa	Florida	33612-9497	—
Not listed	Atlanta	Georgia	30322	—
Not listed	Marietta	Georgia	30060	—
Not listed	Chicago	Illinois	60637	—
Not listed	Boston	Maryland	02115	—
Not listed	Boston	Massachusetts	02114	—
Not listed	Saint Louis Park	Minnesota	55426	—
Not listed	Springfield	Missouri	65807	—
Not listed	Rochester	New York	14642	—
Not listed	Houston	Texas	77030	—
Not listed	Seattle	Washington	98109	—
Not listed	Tacoma	Washington	98405	—
Not listed	Madison	Wisconsin	53705	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01300247, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 1, 2017 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01300247 live on ClinicalTrials.gov.

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