A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma

Conditions

• Lymphoma, Mantle-Cell

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zanubrutinib — DRUG
  160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up
• Rituximab — DRUG
  375 mg/m\^2 ivgtt, D0 of each 28-day cycle
• Bendamustin — DRUG
  90mg/m\^2 ivgtt, D0 of each 28-day cycle

Study Details

The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.

Key Dates

Start date

Nov 15, 2023

Status verified

Nov 2023

Primary completion

Nov 1, 2027

Completion

Nov 1, 2027

Study Design

Enrollment

23 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ZBR

Primary Outcome Measure

2-year Progression-Free Survival [ Time Frame: 2 years ]