- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05504603
Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
August 16, 2022 updated by: The First Affiliated Hospital of Soochow University
A Phase 2 Study of Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
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.
Study Overview
Status
Recruiting
Conditions
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Patients who are evaluated as SD and PD will be withdrawn from the trial,while those who achieve PR and CR will be further stratified according to their age and physical status.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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Suzhou, Jiangsu, China, 215006
- Recruiting
- The First Affiliated Hospital of Soochow University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: zanubrutinib(80mg), rituximab(100mg), ASCT
|
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22.
Other name: Part A
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1.
Other name: Part B
semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6.
zanubrutinib 160mg PO BID.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate(ORR) in all patients
Time Frame: At the end of cycle 3 and cycle 5(each cycle is 28 days)
|
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
Time Frame: At the end of cycle 3 and cycle 5(each cycle is 28 days)
|
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
Time Frame: 1 month after 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
Time Frame: 1 month after ASCT
|
The rate of patients who achieved complete response after ASCT.
|
1 month after ASCT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: up to 24 months after the last patient's enrollment.
|
OS will be assessed from the first ZR given to date of death or end of follow-up.
|
up to 24 months after the last patient's enrollment.
|
Progression Free Survival (PFS)
Time Frame: up to 24 months after the last patient's enrollment.
|
PFS will be assessed from the first ZR given to date of progression, relapse, death or end of follow-up.
|
up to 24 months after the last patient's enrollment.
|
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
Time Frame: initiation of study drug until 30 days after last dose.
|
The safety and tolerability of the therapeutic regimen measured by the 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)
Time Frame: At the end of cycle 5 ZR (each cycle is 28 days) and 1 month after ASCT.
|
At the end of cycle 5 ZR (each cycle is 28 days) and 1 month after ASCT.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 27, 2020
Primary Completion (ANTICIPATED)
July 26, 2023
Study Completion (ANTICIPATED)
July 26, 2025
Study Registration Dates
First Submitted
August 16, 2022
First Submitted That Met QC Criteria
August 16, 2022
First Posted (ACTUAL)
August 17, 2022
Study Record Updates
Last Update Posted (ACTUAL)
August 17, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- Rituximab
- Zanubrutinib
Other Study ID Numbers
- Jinzm 004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All the data would be available at the First Affiliated Hospital and other researchers after the end of the study.
IPD Sharing Time Frame
after the end of the study
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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