Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)

October 8, 2024 updated by: Zhao Weili, Ruijin Hospital

The Efficacy and Safety of Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) Regimen in High-risk Treatment-naive Patients with Follicular Lymphoma

This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 2

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, M.D. and Ph.D
  • Phone Number: 610707 +862164370045
  • Email: zwl_trial@163.com

Study Contact Backup

  • Name: Pengpeng Xu, M.D. and Ph.D
  • Phone Number: 610707 +862164370045
  • Email: pengpeng_xu@126.com

Study Locations

  • China
      • Shanghai, China
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

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

Description

Inclusion Criteria:

  1. Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
  2. Treatment naive
  3. Age ≥ 18 years
  4. Indications for treatment confirmed
  5. Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
  6. Must has measurable lesion in CT or PET-CT prior to treatment
  7. Considered suitable for ZGR regimens
  8. 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
  • Any drug contraindication in the treatment plan
  • Pregnant or lactating women
  • 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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
Drug: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)

Induction therapy:

The ZGR regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 28 days. Participants will receive a total of 6 cycles.

Dosage:

  1. Zanubrutinib, 160 mg bid, po, day 1-28;
  2. Obinutuzumab, 1000mg, ivgtt, day 1/8/15 (C1), day1 (C2-6);
  3. Lenalidomide, 25 mg qd, po, day 2-11.

Maintenance therapy:

  1. Obinutuzumab, ivgtt,1000mg, every 3 months for 2 years;
  2. Lenalidomide, 25mg, PO, during 1-10 days in every 28 days for 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: At the end of Cycle 6 (each cycle is 28 days)
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
At the end of Cycle 6 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Complete response rate (CR)
Time Frame: At the end of Cycle 6 (each cycle is 28 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
At the end of Cycle 6 (each cycle is 28 days)
Partial response rate (PR)
Time Frame: At the end of Cycle 6 (each cycle is 28 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
At the end of Cycle 6 (each cycle is 28 days)
2-year progression free survival rate
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)
2-year overall survival rate
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 death from any cause.
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

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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FL-ZGR

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

product manufactured in and exported from the U.S.

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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