Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07247383
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Marginal Zone Lymphoma of Ocular Adnexal
  • Marginal Zone Lymphoma(MZL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orelabrutinib (ICP-022) — DRUG
    Orelabrutinib was administered in 4 or 6 cycles, respectively, based on subjects' AnnArbor stage as assessed by PETCT，150mg QD D1-28
  • radiotherapy — RADIATION
    Radiotherapy 2Gy\*2
  • Rituximab (R) — DRUG
    Rituximab 375mg/m2 D1

Study Details

This is a phase II, prospective clinical study to evaluate the efficacy and safety of Orelabrutinib combined with Low-Dose Radiotherapy or Rituximab in the treatment of Ocular Adnexal MALT Lymphoma

Key Dates

Start date
Sep 19, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
39 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AnnArbor 1
    Radiotherapy 2GY \* 2 + Orelabrutinib 150 mg qd; 28 days per cycle for 4 cycles
  • Experimental: AnnArbor 2
    Rituximab plus Orelabrutinib 150 mg QD, 28 days per cycle for 4 cycles
  • Experimental: AnnArbor 3-4
    Rituximab plus Orelabrutinib 150 mg QD, 28 days per cycle for 6 cycles

Primary Outcome Measure

Complete Response Rate (CR) [ Time Frame: up to 6 months ]