CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 979 enrolled
Drug / intervention
Bendamustine +4 moredrug
Likely dose
Bendamustine 90 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01905943
NCT01905943Phase 3Completed
CompareCT.gov

A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia

Hoffmann-La Roche·interventional·Posted Jul 23, 2013·Updated Oct 28, 2019

In Brief

A Phase 3 clinical trial evaluating Bendamustine, Chlorambucil, and 3 other interventions for Chronic Lymphocytic Leukemia. Completed, enrolled 979 participants across 174 sites in 31 countries.

Detailed Summary

This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesArgentina, Belgium, Bosnia and Herzegovina, Brazil, Canada, Egypt, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, North Macedonia, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 23, 2013
Enrollment StartNov 4, 2013
Primary CompletionDec 29, 2016
Study CompletionOct 8, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.9 years ago

Interventions

Bendamustinedrug

Bendamustine: 90 milligram per millilitre square (mg/m\^2) IV over 60 minutes once daily (QD) Day 1-2 in participants previously untreated or 70 mg/m\^2 I.V. over 60 minutes QD Day 1-2 in participants with relapsed/refractory disease. In non-fit participants only, investigators may opt at their own discretion to use lower initial doses of bendamustine, i.e., bendamustine 70 mg/m\^2 in previously untreated participants, and bendamustine 50 mg/m\^2 in relapsed/refractory subjects (over 60 minutes qd Day 1-2 for each administration).

Chlorambucildrug

Chlorambucil 0.5 mg/kg p.o. qd on Day 1 and Day 15 in non-fit participants only.

Cyclophosphamidedrug

Cyclophosphamide 250 mg/m\^2 I.V. over 15-30 minutes qd Day 1-3 or Cyclophosphamide 250 mg/m\^2 p.o. QD Day 1-3 in fit participants only.

Fludarabinedrug

Fludarabine 25 mg/m\^2 I.V. over 30 minutes QD Day 1-3 or Fludarabine 40 mg/m\^2 per os (p.o.) QD Day 1-3 in fit participants only.

Obinutuzumabdrug

Participants will receive obinutuzumab 1000 mg IV infusion on Days 1/2 (dose split over 2 consecutive days; 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1, and on Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle is of 28-days duration.