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MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL

ConditionMarginal Zone Lymphoma(MZL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

Marginal zone lymphoma (MZL) is a common type of indolent lymphoma that originates from the marginal zone of lymphoid follicles. This study aims to evaluate targeted therapy based on the prognostic risk stratification of MZL-IPI in newly diagnosed MZL cases requiring systemic treatment, and provides a basis for precision treatment of MZL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Histopathologically confirmed CD20-positive marginal zone lymphoma (according to the 2016 WHO classification).

Helicobacter pylori (HP)-positive or HP - negative gastric mucosa extranodal marginal zone lymphoma (MALT) patients with progression/relapse after local treatment (including surgery, radiotherapy, and anti - Helicobacter pylori treatment).

Non - gastric MALT patients with Ann Arbor stage I - II who have progression/relapse after local treatment (including surgery, radiotherapy, etc.), or untreated patients with Ann Arbor stage III - IV who meet the GELF criteria recommended by the NCCN guidelines.

Splenic marginal zone lymphoma (SMZL) patients with progression/relapse after local treatment (including splenectomy, antiviral treatment for HCV - positive patients, etc.), or untreated patients meeting the criteria of progressive or painful splenomegaly, symptomatic or progressive cytopenia such as HB < 100g/L, PLT < 80×10⁹/L, absolute neutrophil count (ANC) < 1.0×10⁹/L.

Disqualifiers

1. Histologically transformed into high-grade lymphoma. 2. Known central nervous system involvement of MZL. 3. Previous systemic treatment including immunotherapy, chemotherapy or targeted drugs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Obinutuzumab and Orelabrutinib

    Drug

    Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days) and Orelabrutinib (150 mg once daily).

  • Obinutuzumab, Orelabrutinib and Lenalidomide

    Drug

    Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days), Orelabrutinib (150 mg once daily), and Lenalidomide (25 mg on days 2-11 of cycles 1-6, cycle length=21 days).

  • Orelabrutinib

    Drug

    Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).

  • Orelabrutinib

    Drug

    Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).

Treatment groups

145 Participants
are divided into 2 treatment groups
Group A: Obinutuzumab and Orelabrutinib (O2) regimenExperimental treatment 0 interventions
Group B: Obinutuzumab, Orelabrutinib and Lenalidomide (O2R) regimenExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

2-year progression-free survival

Progression-free survival is defined as the time from registration to the first occurrence of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first; as assessed by the investigator.

Time frame
Baseline up to data cut-off (up to 24 months).

Secondary outcomes

1

Complete Response Rate after 6 cycles, at 12 months and 24 months

The proportion of patients with complete response after 6 cycles, 12 months and 24 months from treatment start, according to the 2014 Lugano Response Criteria.

Time frame
At the end of cycle 6, at 12 months and 24 months after treatment start.
2

Overall Response Rate after 6 cycles, at 12 months and 24 months

The proportion of patients with complete and partial response after 6 cycles, 12 months and 24 months from treatment start, according to the 2014 Lugano Response Criteria.

Time frame
At the end of cycle 6, at 12 months and 24 months after treatment start.
3

Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0

Time frame
From enrollment to study completion (up to approximately 24 months).
4

Duration of Response (DOR)

Duration of response is defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause.

Time frame
From enrollment to study completion (up to approximately 24 months).

Other outcomes

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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