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Trial Title:
Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
NCT ID:
NCT05504603
Condition:
Untreated Mantle Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Rituximab
Zanubrutinib
Conditions: Keywords:
Mantle Cell Lymphoma; Zanubrutinib; Rituximab; ASCT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
zanubrutinib and rituximab
Description:
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A
Arm group label:
zanubrutinib(80mg), rituximab(100mg), ASCT
Intervention type:
Drug
Intervention name:
zanubrutinib and rituximab
Description:
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1. Other name: Part B
Arm group label:
zanubrutinib(80mg), rituximab(100mg), ASCT
Intervention type:
Drug
Intervention name:
BEAM pretreatment
Description:
semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5;
melphalan 140mg/m2 IV d6.
Arm group label:
zanubrutinib(80mg), rituximab(100mg), ASCT
Intervention type:
Drug
Intervention name:
zanubrutinib maintenance
Description:
zanubrutinib 160mg PO BID.
Arm group label:
zanubrutinib(80mg), rituximab(100mg), ASCT
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 Patients who are evaluated as SD and PD will be withdrawn from the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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengming Jin
Phone:
+86 0512 67781856
Email:
jinzhengming519519@163.com
Contact backup:
Last name:
Changju Qu
Phone:
+86 0512 67781856
Email:
qcj310@163.com
Start date:
July 27, 2020
Completion date:
July 26, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05504603
