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Clinical Trials in China / NCT06454968
Recruiting Phase 2

Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.

NCT06454968 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Phase 2
Started
2024-06-20
Last updated
2024-06-18

Condition(s) studied

Marginal Zone Lymphoma

Investigational drug(s) / intervention(s)

Orelabrutinib, obinutuzumab, lenalidomide

Orelabrutinib, obinutuzumab, lenalidomide: Orelabrutinib: 150mg qd d1-d21/C1-C6 obinutuzumab: 1000mg iv d1,d8,d15/c1, 1000mg iv d1/C2-C6 lenalidomide：25mg po qd d1-14/C1-C6 Orelabrutinib: 150mg qd d1-d28/C7-C12

Study summary

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years, either sex. * Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal). * At least 1 measurable lesion * Eligible for treatment: meets the GELF criteria, or has clinical symptoms/organ dysfunction related to the disease * Patients who are not suitable for local radiotherapy or whose condition progresses after local treatment, and those not suitable for local radiotherapy include the following situations: * Ann Arbor non-continuous Stage II or Stage III-IV non-gastric MALT and nodal MZL * SMZL (Splenic Marginal Zone Lymphoma) * Gastric MALT with Lugano Stage II2/IIE/IV * ECOG performance status (PS) score of 0-2. * Expected survival time is ≥3 months * Sign the Informed consent Exclusion Criteria: * Currently has other malignant tumors; * Lymphoma involving the central nervous system * Allergic to any of the study drugs; * Active infection or uncontrolled HBV infection (DNA\>105/ml), HIV/AIDS, or other severe infectious diseases; * Pregnant or lactating women and women of childbearing age who are unwilling to use contraception; * Any other conditions deemed unsuitable for participation in this trial by the investigator.

Primary outcome measure(s)

  • the best complete response rate — At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)
    CRR is defined as the proportion of patients with a best response of CR

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting

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Other trials for the same condition

Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy Recruiting
A Cohort Study in Newly Diagnosed MZL Recruiting
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma Active, not recruiting
Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma Starting soon
Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas 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 NCT06454968 on ClinicalTrials.gov ↗ ← All trials in China