An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma

A Multicentric, Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion (SDI) in Patients With Previously Untreated Advanced Follicular Lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224636

Enrollment

112

Registered

2019-04-12

Start date

2019-05-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated advanced follicular lymphoma

Interventions

investigational material(s) Generic name etc : Obinutuzumab INN of investigational material : Obinutuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >/= 18 years at time of signing Informed Consent Form - Patients with previously untreated Stage III or IV FL or Stage II bulky disease scheduled to receive obinutuzumab plus chemotherapy - Histologically documented CD-20-positive FL - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Adequate hematologic function (unless abnormalities are related to FL)

Exclusion criteria

Exclusion criteria: - Relapsed / refractory FL - Prior treatment for FL with chemotherapy, radiotherapy, or immunotherapy - Grade IIIb FL - Histological evidence of transformation of FL into high-grade B-cell non-Hodgkin lymphoma - History of solid organ transplantation - History of anti-CD20 antibody therapy

Design outcomes

Primary

Measure	Time frame
safety Observation / examination	—

Secondary

Measure	Time frame
safety efficacy exploratory Observation / examination	—

Countries

Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026