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Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL

ConditionMarginal Zone Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is a single-arm, multicenter, prospective, phase II study. The primary objective is to assess the efficacy and safety of orelabrutinib in treatment-naïve patients with marginal zone lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years, regardless of gender;

Patients with histopathologically confirmed stage I/II marginal zone lymphoma;

ECOG performance status score of 0-2;

Blood tests: Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, ANC ≥1.0×10^9/L, platelets ≥50×10^9/L, hemoglobin ≥50g/L;

Disqualifiers

Lymphoma involving the central nervous system or transformation to high-grade;

New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of the study drug, or arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) <50%;

Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy);

History of clinically significant QTc interval prolongation, or QTc interval >470 ms for females or >450 ms for males at screening;

Trial design

Design model

Single group

Treatments tested in this trial

  • Orelabrutinib

    Drug

    Induction phase (cycle 1-6): Orelabrutinib (150 mg)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Marginal zone lymphoma: orelabrutinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

The ORR is defined as the proportion of patients with a response of CR or PR.

Time frame
From the initiation of treatment to the end of induction therapy of cycle 6 (each cycle is 28 days)

Secondary outcomes

1

Complete response rate (CRR)

Complete response rate is defined as the proportion of patients with a response of CR.

Time frame
From the initiation of treatment to the end of induction therapy of cycle 6 (each cycle is 28 days)
2

Time to response (TTR)

TTR is defined as the time from the start of therapy to the first response.

Time frame
1years
3

Duration of Response (DOR)

DOR is defined as the time from documentation of response to treatment to the first documentation of tumor progression or death due to any cause, whichever comes first.

Time frame
From the first demonstration of response until disease progression/death, up to 1 years
4

Progression-free survival (PFS)

PFS is defined as the time from enrollment to disease progression or death from any cause. For patients who remain alive and progression-free at the data cutoff date, PFS will be censored at the last tumor assessment date.

Time frame
From the date of enrollment until the date of first documented progression, up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Beijing Tongren Hospital

Collaborator

Source ClinicalTrials.gov
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