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NCT Number: NCT06549335

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

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

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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

Interventional

Phase

Phase 2

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

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
  • Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
  • Must has measurable lesion in CT or PET-CT prior to treatment
  • Considered suitable for ZGR 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
  • Any drug contraindication in the treatment plan
  • Pregnant or lactating women
  • Patients judged by other researchers to be unsuitable for inclusion in the study

Treatment and study plan

Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)

Drug

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:

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

Maintenance therapy:

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

Study contacts

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

Pengpeng Xu, M.D. and Ph.D

CONTACT

[email protected]

+862164370045 ext. 610707

Weili Zhao, M.D. and Ph.D

CONTACT

[email protected]

+862164370045 ext. 610707

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2024
Registry last updated
Oct 15, 2024

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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