NCT06549335

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
6mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

August 8, 2024

Last Update Submit

October 8, 2024

Conditions

Follicular Lymphoma

Keywords

ZanubrutinibLymphoma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    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 Outcomes (5)

  • Complete response rate (CR)

    At the end of Cycle 6 (each cycle is 28 days)

  • Partial response rate (PR)

    At the end of Cycle 6 (each cycle is 28 days)

  • Duration of response

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

  • 2-year progression free survival rate

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

  • 2-year overall survival rate

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

Study Arms (1)

Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)

EXPERIMENTAL
Drug: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)

Interventions

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: 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.

Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma

Interventions

zanubrutinibobinutuzumabLenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Weili Zhao, M.D. and Ph.D

CONTACT

+862164370045zwl_trial@163.com

Pengpeng Xu, M.D. and Ph.D

CONTACT

+862164370045pengpeng_xu@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
First Deputy Director, Hematology Department

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 12, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)