A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma

Conditions

• Newly Diagnosed Mantle Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Young patients (\< 65 years of age) were treated with R-BAP for 6 cycles (efficacy was assessed every 2 cycles, and adverse events were recorded), together with oral ibrutinib, followed by oral ibrutinib for 1 year after chemotherapy (efficacy was assessed every 3 months). Elderly patients (≥65 years of age) received 4 cycles of R-BAP (efficacy assessed every 2 cycles, and adverse reactions recorded), followed by 4 cycles of rituximab consolidation (efficacy assessed every 2 cycles) and 1 year of oral zanubrutinib (efficacy assessed every 3 months).

Study Details

An open-label, single-arm, multicenter, prospective clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma

Key Dates

Start date

Aug 12, 2022

Status verified

Aug 2022

Primary completion

Jun 30, 2024

Completion

Dec 30, 2026

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Arms
  Experimental:Rituximab、Bendamustine、Cytarabine、Prednisone （R-BAP） combined with BTK inhibitors To observe the efficacy and safety of R-BAP combined with BTK inhibitors in the treatment of newly-treated patients with mantle cell lymphoma (MCL)

Primary Outcome Measure

progression free survival（PFS） [ Time Frame: two years ]

Central Contacts

• Zhang Mingzhi Zhang, Doctor
  13838565629
  [email protected]
• Zhang Lei Zhang, Doctor
  13525533696