Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma

NCT05504603 | Unknown Phase 2

• 1 other identifier: Jinzm 004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Untreated Mantle Cell Lymphoma

Keywords

Mantle Cell Lymphoma; Zanubrutinib; Rituximab; ASCT

Outcome Measures

Primary Outcomes (4)

• Overall Response Rate(ORR) in all patients

  The rate of patients who achieved complete response and partial response after ZR combined immunotherapy

  At the end of cycle 3 and cycle 5(each cycle is 28 days)

• Complete Response Rate(CRR) in all patients

  The rate of patients who achieved complete response after ZR combined immunotherapy.

  At the end of cycle 3 and cycle 5(each cycle is 28 days)

• Overall Response Rate(ORR) in patients received ASCT

  The rate of patients who achieved complete response and partial response after ASCT.

  1 month after ASCT

• Complete Response Rate(CRR) in patients received ASCT

  The rate of patients who achieved complete response after ASCT.

  1 month after ASCT

Secondary Outcomes (4)

• Overall Survival (OS)

  up to 24 months after the last patient's enrollment.

• Progression Free Survival (PFS)

  up to 24 months after the last patient's enrollment.

• Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events

  initiation of study drug until 30 days after last dose.

• Minimal Residual Disease (MRD)

  At the end of cycle 5 ZR (each cycle is 28 days) and 1 month after ASCT.

Study Arms (1)

zanubrutinib(80mg), rituximab(100mg), ASCT

EXPERIMENTAL

1. Phase I(Combined Immunotherapy Phase): Part A(Induction Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1,8,15,22. Part B(Consolidation Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1. Treatment cycles repeat every 28 days for 4 cycles. 2. Phase II(ASCT): BEAM pretreatment. Patients receive semustine on day1, etoposide on days 2-5, cytarabine on days 2-5 and melphalan on day 6. 3. Phase III(maintenance): Zanubrutinib

Drug: zanubrutinib and rituximab; Drug: BEAM pretreatment; Drug: zanubrutinib maintenance

Interventions

zanubrutinib and rituximab DRUG

zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A

zanubrutinib(80mg), rituximab(100mg), ASCT

BEAM pretreatment DRUG

semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6.

zanubrutinib(80mg), rituximab(100mg), ASCT

zanubrutinib maintenance DRUG

zanubrutinib 160mg PO BID.

zanubrutinib(80mg), rituximab(100mg), ASCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically or Cytologically confirmed Mantle Cell Lymphoma(excluding indolent Mantle Cell Lymphoma) by the 2008 World Health Organization (WHO) Classification of diseases;
• Initial untreated patients;
• Age ≥ 18 years;
• ECOG score 0-2;
• 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;
• Patients must have measurable disease (i.e., ≥ 1.0 cm in lymph nodes diameter; or skin lesions assessed by physical examination);
• Written informed consent obtained from the subject.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

zanubrutinib; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Zhengming Jin

CONTACT

+86 0512 67781856; jinzhengming519519@163.com

Changju Qu

CONTACT

+86 0512 67781856; qcj310@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: July 27, 2020
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2025
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after the end of the study

Locations

CN (1)