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Clinical Trials in China / NCT06549335
Starting soon Phase 2

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

NCT06549335 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Phase 2
Started
2024-12-01
Last updated
2024-10-15

Condition(s) studied

Follicular Lymphoma

Investigational drug(s) / intervention(s)

Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Objective response rate (ORR) — 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

Trial sites (1)

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

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Other trials for the same condition

Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL) Recruiting
A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006) Active, not recruiting
Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL Recruiting
Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma Recruiting
A Multi-center Clinical Study of Zanubrutinib in Combination With First-line Chemoimmunotherapy in Patients With Grade 3A High-risk Follicular Lymphoma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06549335 on ClinicalTrials.gov ↗ ← All trials in China