A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL

Last updated: June 3, 2023
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Follicular Lymphoma

Lymphoma

Lymphoproliferative Disorders

Treatment

Prednisone

Cyclophosphamide

Obinutuzumab

Clinical Study ID

NCT05899621
FL-Gbased
  • Ages > 18
  • All Genders

Study Summary

This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
  • Treatment naive
  • Age ≥ 18 years
  • Indications for treatment confirmed
  • Must has measurable lesion in CT or PET-CT prior to treatment
  • Considered suitable for GR, GB or GCHOP regimens
  • Informed consented

Exclusion

Exclusion Criteria:

  • Transformed follicular lymphoma or 3B follicular lymphoma;
  • HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive withHCV-RNA; or HIV positive
  • Central nervous system or meninges involved
  • Any drug contraindication in the treatment plan
  • Patients judged by other researchers to be unsuitable for inclusion in the study

Study Design

Total Participants: 332
Treatment Group(s): 7
Primary Treatment: Prednisone
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
June 30, 2027

Study Description

This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Connect with a study center

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.