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

June 3, 2023 updated by: Zhao Weili, Ruijin Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

332

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Weili Zhao, +862164370045
  • Phone Number: 610707 +862164370045
  • Email: zwl_trial@163.com

Study Contact Backup

  • Name: Pengpeng Xu, PhD，MD
  • Phone Number: +862164370045

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients age ≥18 years with grade 1 to 3a FL.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GR
Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); lenalidomide (R), 25mg, PO, D2-11; Maintenance: obinutuzumab (G), 1000mg, every 3 months for 2 years; lenalidomide (R), 25mg, PO, D1-10, every 28 days for 6 cycles
Drug: Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Drug: Obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
GB
Induction(six 21-day cycles): obinutuzumab (G) 1000mg, IV, D1/8/15 (C1), D1 (C2-6); bendamustine (B), 90 mg/m2, IV, D1-2; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years
Drug: Obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Bendamustine
Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.
GCHOP
Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); prednisone (P), 100 mg, PO, D1-5；cyclophosphamide (C), 750 mg/m2, IV, D1; vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D1; doxorubicin (H), 50 mg/m2, IV, D1; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years
Drug: Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Drug: Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
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.
Baseline up to data cut-off (up to approximately 2 years)
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.
Baseline up to data cut-off (up to approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Study Chair: Weili Zhao, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

June 3, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 3, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FL-Gbased

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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