Status:
RECRUITING
Zanubrutinib-based Induction and Maintenance Therapy in Young and Fit Patients With Untreated Mantle Cell Lymphoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a prospective, single-center, single-arm, phase II study of Zanubrutinib-based induction followed by ASCT and Zanubrutinib maintenance (2 years) or followed directly by Zanubrutinib maintenanc...
Eligibility Criteria
Inclusion
- 1\. Histologically confirmed diagnosis of MCL according to WHO classification
- Previously untreated MCL
- Suitable for high-dose treatment including high-dose Ara-C
- Age ≥ 18 years and ≤ 65 years
- Stage II-IV (Ann Arbor)
- Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI). Measurable disease was defined as at least 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions; in case of bone marrow infiltration only, bone marrow aspiration and biopsy are mandatory for all staging evaluations
- ECOG performance status ≤ 2
- The following laboratory values at screening (unless related to MCL):
- Absolute neutrophil count (ANC) ≥ 1×10⁹/L
- Platelets ≥ 75×10⁹/L (platelets ≥ 50×10⁹/L with bone marrow involvement)
- Transaminases (AST and ALT) ≤ 3 × upper limit of normal (ULN)
- Total bilirubin ≤ 2 × ULN (unless documented Gilbert's syndrome)
- Calculated creatinine clearance ≥ 30 mL/min
- International normalized ratio ≤ 1.5 and activated partial thromboplastin time ≤ 1.5 x upper limit of normal. If a factor inhibitor was present with prolongation of the international normalized ratio or activated partial thromboplastin time.
- Sexually active men and women of child-bearing potential must agree to use highly effective contraceptives (eg, condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug
- Life expectancy of\> 3 months
- Written informed consent form according to GCP and national regulations
Exclusion
- Known CNS involvement of MCL
- Major surgery within 4 weeks of screening
- Prior hematopoietic stem cell transplantation
- Concomitant or previous malignancies within the last 2 years other than basal cell skin cancer or in situ uterine cervix cancer
- Clinically significant cardiovascular disease such as uncontrolled arrhythmias and hypertension , congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below 50%（AHA，2016）
- QTcF \> 450 msec or other significant electrocardiogram (ECG) abnormalities including second-degree atrioventricular block Type II, or third-degree atrioventricular block
- Clinically significant hypersensitivity (eg, anaphylactic or anaphylactoid reactions to the compound of zanubrutinib itself or to the excipients in its formulation)
- Requires treatment with strong CYP3A inhibitors or strong CYP3A inducers
- Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
- Patients with unresolved hepatitis B or C infection or known HIV positive infection
- Active infection including infections requiring oral or intravenous antimicrobial therapy
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could have compromised the patient's safety, or put the study at risk
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
- Pregnancy or lactation
- Participation in another clinical trial within 30 days before enrollment in this study
- poor compliance
Key Trial Info
Start Date :
January 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04736914
Start Date
January 31 2021
End Date
February 28 2026
Last Update
August 26 2021
Active Locations (1)
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1
Department of Medical Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060