About this trial
An open-label, single-arm, multicenter, prospective clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-70, ECOG score 0-2;
Estimated survival time >6 months;
Mantle cell lymphoma was confirmed by pathology.
Acceptable hematological indexes without chemotherapy contraindications; Neutrophil absolute value ≥1.0×10^9 /L, PLT≥75×10^9 /L, hemoglobin ≥80g/L (except patients with lymphoma bone marrow infiltration);
Disqualifiers
Patients with definite neuropathy or psychosis, including dementia or seizures, a history of psychotropic substance abuse and inability to abstinence, or other substantial lesions that may increase CNS toxicity;
Participating in other clinical trials or participating in other clinical investigators 4 weeks before enrollment (except those not receiving treatment);
Systemic autoimmune disease or immune deficiency;
Refusing to collect blood samples;
Trial population
A newly diagnosed patient with mantle cell lymphoma
Trial design
Case-only
Prospective
Treatments tested in this trial
Rituximab
DrugYoung 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).
Treatment groups
Trial outcomes
Primary outcomes
progression free survival(PFS)
progression free survival
Secondary outcomes
ORR
objective remission rate
CRR
complete remission rate
OS
overall survival
ADR
adverse drug reaction
Sponsors and contacts
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