Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance with Zanubrutinib for Newly-Diagnosed MCL

Sponsor
Sun Yat-sen University
Study ID
NCT04624958
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Mantle Cell Lymphoma
  • Newly-diagnosed Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib and Rituximab — DRUG
    Zanubrutinb 160mg PO BID d1-28; Rituximab 375mg/m2 iv.drip d1.
  • R-DHAOx — DRUG
    Rituximab 375mg/m2 iv.drip d1; Dexamethasone 20mg iv.drip d1-4; Cytarabine 2000mg/m2 (1000mg/m2 for patients aged over 65) iv.drip d2,3 Oxaliplatin 130mg/m2 iv.drip d1.
  • Zanubrutinib Maintenance — DRUG
    Zanubrutinb 160mg PO BID.

Study Details

This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL).

Key Dates

Start date
Dec 1, 2020
Status verified
Oct 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: zanubrutinib, rituximab, consolidation chemotherapy and zanubrutinb maintenance
    Part A (Zanubrutinib and Rituximab): Patients receive zanubrutinib on days 1-28 and rituximab on day 1. Treatment cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or until patients achieve CR. PART B (Consolidation chemotherapy of R-DHAOx): Patients receive R-DHAOx regimen every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Elderly patients (\> 65 years old) and patients who achieved CR and minimal residual disease negative after PART B receive zanubrutinb maintenance therapy. Young patients (\<65 years old) who achieved CR but minimal residual disease positive after PART B can receive autologous stem cell transplantation and then zanubrutinb maintenance therapy. Patients with PD, SD or PR after PART B quit the trial. ZANUBRUTINB MAINTENANCE: Patients receive zanubrutinib every day for up to one year.

Primary Outcome Measure

Complete remission rate after PART A [ Time Frame: 3 years ]

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