Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

Observational, non-interventional, retrospective, multicentre study focusing on efficacy and safety of zanubrutinib in daily clinical practice in patients with relapsed/refractory (R/R) marginal zone lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of relapsed/refractory marginal zone lymphoma

Patients who received at least one dose of zanubrutinib under the Named patient program (D.M. 7 Sep 2017), between January 2021 and October 2023 3) Age≥18 at start of zanubrutinib therapy. 4) Signature of written informed consent to study participation and personal data processing.

Disqualifiers

None

Trial population

Patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under the Named patient program (D.M. 7 Sep 2017), between January 2021 and October 2023.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

the sum of the Complete Response \[CR\] and Partial Response \[PR\]) in accordance with the Lugano Classification

Time frame
through the duration of study, an average of 6 months

Secondary outcomes

1

Duration of response (DoR)

To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program

Time frame
through the duration of study, an average of 6 months
2

Progression Free Survival (PFS)

To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program

Time frame
through the duration of study, an average of 6 months
3

Overall Survival (OS)

To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program

Time frame
through the duration of study, an average of 6 months
4

Best response rate (BRR),

To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program

Time frame
through the duration of study, an average of 6 months

Other outcomes

Sponsors and contacts

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