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

Primary Purpose

Untreated Mantle Cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
zanubrutinib and rituximab
zanubrutinib and rituximab
BEAM pretreatment
zanubrutinib maintenance
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Untreated Mantle Cell Lymphoma focused on measuring Mantle Cell Lymphoma; Zanubrutinib; Rituximab; ASCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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. 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. Phase III(maintenance): Zanubrutinib

Outcomes

Primary Outcome Measures

Overall Response Rate(ORR) in all patients
The rate of patients who achieved complete response and partial response after ZR combined immunotherapy
Complete Response Rate(CRR) in all patients
The rate of patients who achieved complete response after ZR combined immunotherapy.
Overall Response Rate(ORR) in patients received ASCT
The rate of patients who achieved complete response and partial response after ASCT.
Complete Response Rate(CRR) in patients received ASCT
The rate of patients who achieved complete response after ASCT.

Secondary Outcome Measures

Overall Survival (OS)
OS will be assessed from the first ZR given to date of death or end of follow-up.
Progression Free Survival (PFS)
PFS will be assessed from the first ZR given to date of progression, relapse, death or end of follow-up.
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
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.
Minimal Residual Disease (MRD)

Full Information

First Posted
August 16, 2022
Last Updated
August 16, 2022
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05504603
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
July 26, 2023 (Anticipated)
Study Completion Date
July 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Untreated Mantle Cell Lymphoma
Keywords
Mantle Cell Lymphoma; Zanubrutinib; Rituximab; ASCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
zanubrutinib(80mg), rituximab(100mg), ASCT
Arm Type
Experimental
Arm Description
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. 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. Phase III(maintenance): Zanubrutinib
Intervention Type
Drug
Intervention Name(s)
zanubrutinib and rituximab
Intervention Description
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A
Intervention Type
Drug
Intervention Name(s)
zanubrutinib and rituximab
Intervention Description
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1. Other name: Part B
Intervention Type
Drug
Intervention Name(s)
BEAM pretreatment
Intervention Description
semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6.
Intervention Type
Drug
Intervention Name(s)
zanubrutinib maintenance
Intervention Description
zanubrutinib 160mg PO BID.
Primary Outcome Measure Information:
Title
Overall Response Rate(ORR) in all patients
Description
The rate of patients who achieved complete response and partial response after ZR combined immunotherapy
Time Frame
At the end of cycle 3 and cycle 5(each cycle is 28 days)
Title
Complete Response Rate(CRR) in all patients
Description
The rate of patients who achieved complete response after ZR combined immunotherapy.
Time Frame
At the end of cycle 3 and cycle 5(each cycle is 28 days)
Title
Overall Response Rate(ORR) in patients received ASCT
Description
The rate of patients who achieved complete response and partial response after ASCT.
Time Frame
1 month after ASCT
Title
Complete Response Rate(CRR) in patients received ASCT
Description
The rate of patients who achieved complete response after ASCT.
Time Frame
1 month after ASCT
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS will be assessed from the first ZR given to date of death or end of follow-up.
Time Frame
up to 24 months after the last patient's enrollment.
Title
Progression Free Survival (PFS)
Description
PFS will be assessed from the first ZR given to date of progression, relapse, death or end of follow-up.
Time Frame
up to 24 months after the last patient's enrollment.
Title
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
Description
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.
Time Frame
initiation of study drug until 30 days after last dose.
Title
Minimal Residual Disease (MRD)
Time Frame
At the end of cycle 5 ZR (each cycle is 28 days) and 1 month after ASCT.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengming Jin
Phone
+86 0512 67781856
Email
jinzhengming519519@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Changju Qu
Phone
+86 0512 67781856
Email
qcj310@163.com
Facility Information:
Facility Name
the First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengming Jin
Phone
+86 0512 67781856
Email
jinzhengming519519@163.com
First Name & Middle Initial & Last Name & Degree
Changju Qu
Phone
+86 0512 67781856
Email
qcj310@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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