Brief Summary

This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+) malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated time on study treatment is 24 weeks.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Sep 2012

Typical duration for phase_1

Geographic Reach

1 country

4 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Start

First participant enrolled

September 1, 2012

Completed

3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

April 25, 2016

Completed

Last Updated

April 25, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

September 4, 2012

Results QC Date

March 23, 2016

Last Update Submit

March 23, 2016

Conditions

Lymphocytic Leukemia, Chronic, Diffuse Large B-cell Lymphoma, Follicular Lymphoma

Outcome Measures

Primary Outcomes (4)

Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1
DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.
Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8
Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1
DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.
Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8
Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8
Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
Cmax of Obinutuzumab at Cycle 8
Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1

Secondary Outcomes (18)

Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8
Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
Apparent Terminal Half-life (t1/2)
Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing
Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8
Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8
Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
Minimum Observed Serum Concentration of Obinutuzumab
Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1
+13 more secondary outcomes

Study Arms (3)

CLL: 1000 mg Obinutuzumab

EXPERIMENTAL

Participants with chronic lymphocytic leukemia (CLL) will receive 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. The first infusion on Cycle 1 Day 1 will be given over two days: Day 1 and Day 2. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.

Drug: Obinutuzumab

DLBCL: 1000 mg Obinutuzumab

EXPERIMENTAL

Participants with diffuse large B-cell lymphoma (DLBCL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.

Drug: Obinutuzumab

FL: 1000 mg Obinutuzumab

EXPERIMENTAL

Participants with follicular lymphoma (FL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.

Drug: Obinutuzumab

Interventions

ObinutuzumabDRUG

Multiple doses of obinutuzumab.

Also known as: RO5072759, GA101

CLL: 1000 mg ObinutuzumabDLBCL: 1000 mg ObinutuzumabFL: 1000 mg Obinutuzumab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of CD20+ B-cell lymphoma or B-CLL
Refractory/relapsed CLL, FL, and DLBCL
At least 1 measurable lesion (greater than \[\>\] 1.5 centimeters \[cm\] in its largest dimension) with the exception of CLL
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy \>6 months

You may not qualify if:

Prior use of any investigational antibody therapy within 6 months of study start
Prior use of any anti-cancer vaccine
Prior administration of rituximab within 3 months of study start
Prior administration of radioimmunotherapy 3 months prior to study entry
Central nervous system lymphoma
History of other malignancy
Evidence of significant, uncontrolled concomitant disease
Abnormal laboratory values
Patients with progressive multifocalleukoencephalopathy (PML)
Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Hoffmann-La Rochelead

Study Sites (4)

Unknown Facility

Beijing, 100021, China

Location

Unknown Facility

Beijing, 100142, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Shanghai, 200025, China

Location

Related Publications (2)

Qin Y, Song Y, Shen Z, Du X, Ji W, Hsu W, Zhu J, Shi Y. Safety and efficacy of obinutuzumab in Chinese patients with B-cell lymphomas: a secondary analysis of the GERSHWIN trial. Cancer Commun (Lond). 2018 May 30;38(1):31. doi: 10.1186/s40880-018-0300-5.
PMID: 29843792DERIVED
Zhai J, Qin Y, Zhu J, Song Y, Shen Z, Du X, Jamois C, Brewster M, Shi Y, Shi J. Pharmacokinetics of obinutuzumab in Chinese patients with B-cell lymphomas. Br J Clin Pharmacol. 2017 Jul;83(7):1446-1456. doi: 10.1111/bcp.13232. Epub 2017 Feb 14.
PMID: 28072473DERIVED

MeSH Terms

Conditions

Leukemia, LymphoidBronchiolitis Obliterans SyndromeLymphoma, Large B-Cell, DiffuseLymphoma, Follicular

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseLymphoma, B-CellLymphoma, Non-HodgkinLymphoma

Results Point of Contact

Title: Medical Communications
Organization: Hoffmann-LaRoche

Study Officials

Clinical Trials
Hoffmann-La Roche
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 25, 2016

Results First Posted

April 25, 2016

Record last verified: 2016-03

Locations

CN(4)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (18)

Study Arms (3)

CLL: 1000 mg Obinutuzumab

DLBCL: 1000 mg Obinutuzumab

FL: 1000 mg Obinutuzumab

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations