Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05504603
Phase
PHASE2
Status
Unknown

Conditions

  • Untreated Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • zanubrutinib and rituximab — DRUG
    zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A
  • zanubrutinib and rituximab — DRUG
    zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1. Other name: Part B
  • BEAM pretreatment — DRUG
    semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6.
  • zanubrutinib maintenance — DRUG
    zanubrutinib 160mg PO BID.

Study Details

The proposed study is a prospective, single-center, single-arm and open-ended phase II study in patients over the age of 18 with previously untreated mantle cell lymphoma(MCL). The primary objective of this study is to explore the safety and efficacy of a new chemo-free treatment pattern zanubrutinib-rituximab(ZR) in newly diagnosed MCL.

Key Dates

Start date
Jul 27, 2020
Status verified
Aug 2022
Primary completion
Jul 26, 2023
Completion
Jul 26, 2025

Study Design

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

Arms

  • Experimental: zanubrutinib(80mg), rituximab(100mg), ASCT
    1. Phase I(Combined Immunotherapy Phase): Part A(Induction Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1,8,15,22. Part B(Consolidation Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1. Treatment cycles repeat every 28 days for 4 cycles. 2. Phase II(ASCT): BEAM pretreatment. Patients receive semustine on day1, etoposide on days 2-5, cytarabine on days 2-5 and melphalan on day 6. 3. Phase III(maintenance): Zanubrutinib

Primary Outcome Measure

Overall Response Rate(ORR) in all patients [ Time Frame: At the end of cycle 3 and cycle 5(each cycle is 28 days) ]

Central Contacts