Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)

Sponsor
Sun Yat-sen University
Study ID
NCT04989621
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Orelabrutinib and Rituximab — DRUG
    Orelabrutinib 150mg po qd d1-28; Rituximab 375mg/m2 iv.drip d1.
  • Orelabrutinib — DRUG
    Orelabrutinib 150mg po qd

Study Details

This phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(RR FL)

Key Dates

Start date
Aug 1, 2021
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib
    Induction therapy: Patients receive Orelabrutinib at a dose of 25 mg once daily on days 1-28 and rituximab at a dose of 375mg/m2 on day 1. Treatment cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. If patients achieve CR or PR or SD, they will be treated with maintenance therapy Maintenance therapy: Patients receive Orelabrutinib every day at a dose of 150mg for up to two years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response rate [ Time Frame: 2 years ]

Central Contacts

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