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NCT Number: NCT05899621

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

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

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Key information

Conditions

Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Weili Zhao, M.D. and Ph.D

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • Transformed follicular lymphoma or 3B follicular lymphoma;
  • HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-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

Treatment and study plan

Obinutuzumab

Drug

Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.

Lenalidomide

Drug

Lenalidomide PO will be administered as per the schedule specified in the respective arm.

Bendamustine

Drug

Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.

Cyclophosphamide

Drug

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

Doxorubicin

Drug

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

Vincristine

Drug

Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

Prednisone

Drug

Prednisone PO will be administered as per the schedule specified in the respective arm.

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

    Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria

Secondary outcomes

  1. Complete response rate (CR)

    Time frame: End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

    Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

  2. Progression free survival

    Time frame: Baseline up to data cut-off (up to approximately 2 years)

    Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

  3. Duration of response

    Time frame: Baseline up to data cut-off (up to approximately 2 years)

    Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

Study contacts

Contact information is provided by the study sponsor or research team.

Pengpeng Xu, PhD，MD

CONTACT

+862164370045

Weili Zhao, +862164370045

CONTACT

[email protected]

+862164370045 ext. 610707

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jun 12, 2023
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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