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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorZhengzhou University

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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).

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Arms1 intervention

Trial outcomes

Primary outcomes

1

progression free survival(PFS)

progression free survival

Time frame
two years

Secondary outcomes

1

ORR

objective remission rate

Time frame
two years
2

CRR

complete remission rate

Time frame
two years
3

OS

overall survival

Time frame
two years
4

ADR

adverse drug reaction

Time frame
two years

Other outcomes

Sponsors and contacts

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