Marginal Zone Lymphoma(MZL)
Conditions
Brief summary
This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.
Interventions
OTHERObservation
Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will undergo observation without maintenance anti-lymphoma therapy.
DRUGRituximab
Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will receive rituximab maintenance every 8 weeks for up to 2 years.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and voluntarily sign the informed consent form. * Age ≥18 years. * Histologically confirmed CD20-positive marginal zone lymphoma, including extranodal, splenic, or nodal subtypes. * Considered unsuitable for or unable to tolerate standard chemotherapy. * Previously untreated with systemic anti-lymphoma therapy. * Measurable or evaluable disease according to Lugano 2014 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate organ function.
Exclusion criteria
* History of other malignancies that may interfere with study assessment. * Central nervous system involvement by lymphoma. * Known HIV infection or active hepatitis B/C infection. * Active or uncontrolled infection. * Gastrointestinal condition that may interfere with oral administration or absorption of study treatment. * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year progression-free survival rate | At 2 years after randomization | The 2-year progression-free survival rate is defined as the proportion of patients who are alive without disease progression at 2 years after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | Up to 24 months after randomization | Complete response rate is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria during the maintenance or observation period. |
| Overall response rate | Up to 24 months after randomization | Overall response rate is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria during the maintenance or observation period. |
| Duration of response | Up to 24 months after randomization | Duration of response is defined as the time from the first documented complete response or partial response to disease progression, relapse, or death from any cause, whichever occurs first. |
| Overall survival | Up to 24 months after randomization | Overall survival is defined as the time from randomization to death from any cause. |
| Event-free survival | Up to 24 months after randomization | Event-free survival is defined as the time from randomization to disease progression, relapse, initiation of new systemic anti-lymphoma therapy, or death from any cause, whichever occurs first. |
| Disease-free survival | Up to 24 months after randomization | Disease-free survival is defined as the time from the first documented complete response to disease relapse, progression, or death from any cause, whichever occurs first. |
| Incidence of progression of disease within 24 months | Within 24 months from the start of induction therapy | POD24 is defined as the proportion of patients who experience disease progression, relapse, or death from any cause within 24 months from the start of frontline induction therapy. |
| Patient-reported outcomes | Up to 24 months after randomization | Patient-reported outcomes will be assessed using the EORTC QLQ-C30 questionnaire. |
| Incidence of adverse events and serious adverse events | Up to 30 days after the last study treatment or during follow-up as clinically indicated | The incidence and severity of adverse events and serious adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. |
Countries
China
Contacts
CONTACTCai Qingqing
Outcome results
None listed