Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.
Recruiting
Phase 2Interventional Study
Marginal Zone Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Peking Union Medical College Hospital · Other
Who this trial is looking for
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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).
Trial Locations
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Eligibility Criteria
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
* P…
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.
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