NCT03817853 · FLOW

Participant flow

An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma · Source last updated 2024-04-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
id
FG000
title
All Participants
description
Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).
id
FG001
title
Maintenance
description
Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
id
FG002
title
Follow-up

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
5
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
Adverse Event
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
Measures due to covid19; transformation to double hit high-grade b lymphoma; discontinuation of trt.
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
Physician Decision
reasons
group Id
FG000
num Subjects
6
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
Progressive Disease
reasons
group Id
FG000
num Subjects
4
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
Withdrawal by Subject
milestones
achievements
group Id
FG000
num Subjects
113
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
STARTED
achievements
group Id
FG000
num Subjects
93
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
20
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
NOT COMPLETED
title
Induction Phase
drop Withdraws
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
8
group Id
FG002
num Subjects
0
type
Adverse Event
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
5
group Id
FG002
num Subjects
0
type
Death
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
7
group Id
FG002
num Subjects
0
type
Progressive Disease
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
2
group Id
FG002
num Subjects
0
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
0
type
Physician Decision
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
4
group Id
FG002
num Subjects
0
type
Various reasons
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
0
type
Protocol Deviation
milestones
achievements
group Id
FG000
num Subjects
0
comment
3 participants started the maintenance phase after discontinuing from the induction phase due to COVID-19 measures.
group Id
FG001
num Subjects
95
group Id
FG002
num Subjects
0
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
67
group Id
FG002
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
28
group Id
FG002
num Subjects
0
type
NOT COMPLETED
title
Maintenance Phase
drop Withdraws
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
2
type
Adverse Event
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
1
type
Death
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
3
type
Progressive Disease
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
1
type
Withdrawal by Subject
milestones
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
comment
14 participants discontinued the induction phase but started the follow-up phase. Note that it was not a requirement to complete the maintenance phase to be allowed to enter the follow-up phase.
group Id
FG002
num Subjects
99
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
92
type
COMPLETED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
7
type
NOT COMPLETED
title
Follow-up Phase

pre Assignment Details

Of the all participants population (114 participants), one participant did not receive the study treatment, thus the safety-evaluable population included 113 participants.

recruitment Details

Participants were enrolled at 35 sites across 7 countries.

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