Health Trials

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

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

Treatments tested in this trial

  • Obinutuzumab and Orelabrutinib
  • Obinutuzumab, Orelabrutinib and Lenalidomide
  • Orelabrutinib
  • Orelabrutinib

Treatment groups

145 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov