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A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia

NCT01905943 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 979

Last updated 2019-10-28

Study results available
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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.

Conditions

Interventions

DRUG

Bendamustine

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).

DRUG

Chlorambucil

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

DRUG

Cyclophosphamide

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.

DRUG

Fludarabine

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.

DRUG

Obinutuzumab

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-04
Primary Completion
2016-12-29
Completion
2018-10-08
FDA Drug
Yes

Countries

  • Argentina
  • 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)

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905943 on ClinicalTrials.gov