Clinical trial NCT05504603: Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
Official title: A Phase 2 Study of Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Untreated Mantle Cell Lymphoma
Keywords: Mantle Cell Lymphoma; Zanubrutinib; Rituximab; ASCT
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study is a prospective, single-center, single-arm and open-ended phase II study in patients over the age of 18 with previously untreated mantle cell lymphoma(MCL). The primary objective of this study is to explore the safety and efficacy of a new chemo-free treatment pattern zanubrutinib-rituximab(ZR) in newly diagnosed MCL.

Detailed description: The study will start with an initial 28-days of induction immunotherapy with ZR and 4 cycles of consolidation immunotherapy with ZR，following imaging examinations to evaluate response rates. Patients who are evaluated as SD and PD will be withdrawn from the trial,while those who achieve PR and CR will be further stratified according to their age and physical status. The older or frail patients who are ineligible for ASCT will take zanubrutinib orally until intolerable toxicity or disease progression. Patients who are young and fit for transplantation will receive ASCT consolidation. After ASCT, patients with CR will end therapy and enter the follow-up stage, while patients with PR will continue to take zanubrutinib orally until intolerable toxicity or disease progression.

Eligibility criteria: Inclusion Criteria:

1. Histopathologically or Cytologically confirmed Mantle Cell Lymphoma(excluding indolent Mantle Cell Lymphoma) by the 2008 World Health Organization (WHO) Classification of diseases;
2. Initial untreated patients;
3. Age ≥ 18 years;
4. ECOG score 0-2;
5. Women must not be pregnant or breastfeeding and agree to avoid pregnancy prior to study entry, for the duration of study participation, and for 12 months thereafter. Male patients must agree that their spouses will not become pregnant during the study period and for 12 months thereafter;
6. Patients must have measurable disease (i.e., ≥ 1.0 cm in lymph nodes diameter; or skin lesions assessed by physical examination);
7. Written informed consent obtained from the subject.

Exclusion Criteria:

1. Indolent Mantle Cell Lymphoma;
2. Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal)
3. Uncontrolled active infection, with the exception of tumor-related B symptom fever;
4. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
5. Co-existence of other tumors;
6. Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.

Primary outcomes:
measure: Overall Response Rate(ORR) in all patients
timeFrame: At the end of cycle 3 and cycle 5(each cycle is 28 days)
measure: Complete Response Rate(CRR) in all patients
timeFrame: At the end of cycle 3 and cycle 5(each cycle is 28 days)
measure: Overall Response Rate(ORR) in patients received ASCT
timeFrame: 1 month after ASCT
measure: Complete Response Rate(CRR) in patients received ASCT
timeFrame: 1 month after ASCT
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 24 months after the last patient's enrollment.
measure: Progression Free Survival (PFS)
timeFrame: up to 24 months after the last patient's enrollment.
measure: Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
timeFrame: initiation of study drug until 30 days after last dose.
measure: Minimal Residual Disease (MRD)
timeFrame: At the end of cycle 5 ZR (each cycle is 28 days) and 1 month after ASCT.
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: