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Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL

ConditionMarginal Zone Lymphoma(MZL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years, either sex.

Histopathologically confirmed CD20-positive marginal zone lymphoma (including MALT, SMZL, and NMZL) with at least 1 measurable lesion.

Stage III or IV disease with an indication for treatment.

No prior systemic therapy. Patients may have received prior local treatment (including surgery, radiotherapy, anti-Helicobacter pylori therapy, or anti-hepatitis C therapy) if they subsequently progressed, relapsed, or were unsuitable for local therapy.

Disqualifiers

Current or history of other malignancies, unless treated with curative intent and without evidence of recurrence or metastasis within the past 5 years.

Central nervous system involvement or transformation to high-grade lymphoma.

New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first study drug dose, or arrhythmia requiring treatment at screening; left ventricular ejection fraction (LVEF) <50%.

Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive, or unclassified cardiomyopathy).

Trial design

Design model

Single group

Treatments tested in this trial

  • Orelabrutinib

    Drug

    Orelabrutinib: 150mg qd C1-C6

  • Rituximab

    Drug

    Rituximab: C1-C6

  • Lenalidomide

    Drug

    After 6 cycles of orelabrutinib + rituximab CR: Continue orelabrutinib + rituximab for 6 cycles. PR/SD: Switch to orelabrutinib + rituximab + lenalidomide for 6 cycles. PD: Discontinue study treatment.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Orelabrutinib Combined with Rituximab ± LenalidomideExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Complete response rate (CRR)

CRR is defined as the proportion of patients with complete response

Time frame
At the end of cycle 12 (each cycle is 21 days)

Secondary outcomes

1

Overall response rate (ORR)

ORR is the proportion of patients who achieve either a complete or partial response

Time frame
At the end of cycle 12(each cycle is 21 days)
2

2 years Progression free survival (PFS)

PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.

Time frame
From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
3

2 years overall survival (OS)

Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date

Time frame
From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov
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