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CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma

ConditionMZL
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenan Cancer Hospital

About this trial

This is a multicenter, real-world study on first-line CD20 monoclonal antibody-based regimens for treatment-naive marginal zone B-cell lymphoma based on risk stratification. The primary objective is to evaluate the efficacy and safety of the "BR", "R2", and "OR2" treatment regimens in treatment-naive MZL patients receiving first-line CD20 monoclonal antibody-based therapy stratified by risk.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed marginal zone B-cell lymphoma (MZL) in accordance with the 2016 WHO classification;

Age ≥ 18 years, with no gender restriction;

Gastric extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma), HP-positive or HP-negative, with progression/relapse after local therapy (including surgery, radiotherapy, and anti-Helicobacter pylori treatment);

ECOG performance status 0, 1, or 2 (Appendix 4);

Disqualifiers

Histological transformation to high-grade lymphoma.

Known central nervous system (CNS) involvement by lymphoma or evidence of CNS disease.

Prior systemic therapy, including immunotherapy, chemotherapy, or targeted therapy.

Prior autologous stem cell transplantation, or allogeneic tissue / solid organ transplantation.

Trial population

Hospital

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • R2/BR/OR2

    Drug

    R2 regimen: 28-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 1 to Day 21 of each cycle (Cycles 1-6). BR regimen: 28-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Bendamustine was given via intravenous infusion at 70 mg/m² on Day 1 and Day 2 of each cycle (Cycles 1-6). OR2 regimen: 21-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 2 to Day 11 of each cycle (Cycles 1-6); Orelabrutinib was administered orally at 150 mg per day for 2 years .

Treatment groups

131 Participants
are divided into 1 treatment group
Group A: R2/BR/OR21 intervention

Trial outcomes

Primary outcomes

1

Complete Response Rate（CRR）

The proportion of patients who achieved complete remission (CR) after the completion of treatment was evaluated in accordance with the revised criteria for the assessment of malignant lymphoma efficacy proposed at the 2014 Lugano Conference

Time frame
up to 24 weeks

Secondary outcomes

1

2-year progression-free survival (PFS) rate

The percentage of patients who remained alive and free of disease progression at 2 years after study entry, whichever occurred first

Time frame
2 years
2

2-year overall survival (OS) rate

The percentage of patients who remained alive at 2 years after study entry.

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: