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Trial Title:
This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
NCT ID:
NCT06427213
Condition:
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Obinutuzumab
Zanubrutinib
Conditions: Keywords:
Zanubrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zanubrutinib,Obinutuzumab
Description:
Zanubrutinib, 160mg PO BID. C1D17 continuously for 1 year or until progressive disease；
Obinutuzumab ：Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and
15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks，up to
20 doses. 1 cycle = 28 days.
Maintenance: Zanubrutinib, 160mg PO BID
Arm group label:
Elder Patients（≥65）
Intervention type:
Drug
Intervention name:
Zanubrutinib and R-BAC
Description:
Induction: Zanubrutinib and R-BAC 6 cycles
Consolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly
entered into maintenance treatment
Maintenance: Zanubrutinib continued until progression
Arm group label:
Young Patients with High risk （≥18，<65）
Summary:
This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in
patients with newly diagnosed mantle cell lymphoma.
Detailed description:
This study is a prospective, multicenter, investigator-initiated clinical trial to
evaluate the efficacy and safety of zanubrutinib-containing regimens in the treatment of
newly diagnosed elderly or young patients with high risk MCL, aiming to find a more
optimal treatment regimen for elderly or young patients with high risk MCL to improve the
efficacy, survival time and quality of life of patients.
In elderly patients arm：patients start with the induction therapy of zanubrutinib
combined with obinutuzumab for 1 year and then entered the maintenance therapy of
zanubrutinib orally until intolerable toxicity or disease progression
In young patients with high risk arm：patiens <65 years，and meet one or more of the
following risk factors: TP53 mutation, blastoid/pleomorphic type, high sMIPI score.
patients start with 6 cycles of induction therapy with zanubrutinib combined with R-BAC
regimen, and the patients who achieve CR/PR and meet the transplantation criteria will
receive ASCT consolidationand, then received maintenance therapy with zanubrutinib.
otherwise, Patients who is ineligible for transplantation，will take zanubrutinib orally
until intolerable toxicity or disease progression.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary participation in clinical study; Fully understand and understand the study
and sign the informed consent form (ICF);Willingness to follow and ability to
complete all study steps
2. Histopathologically confirmed mantle cell lymphoma according to the 5th edition of
the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma
(MCL)
3. The elderly group ≥65 years old;The young group was ≥18 years old and < 65 years
old.
4. ECOG Performance Status 0-3
5. Life expectancy of at least 3 months
6. At least one evaluable lesion according to 2014 Lugano criteria;
7. Proper functioning of the major organs, no major heart, lung, liver, kidney, or
immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or
other medical support within 7 days before starting the study) :Hemoglobin (HB)≥60
g/L;Absolute neutrophil count(ANC)≥0.5×10^9/L;Platelet count（PLT）≥50×10^9/L;AST and
ALT ≤ 2.5 x ULN；Total bilirubin ≤ 1.5 times the ULN;Ccr≥40ml/min（Cockcroft-Gault
）；Left Ventricular Ejection Fraction (LVEF) ≥ 50%
Exclusion Criteria:
1. The presence of other tumors could affect the study medication or interfere with the
results;
2. Patients require treatment with strong or moderate CYP3A inhibitors;
3. Pregnant or lactating women;
4. Known to be allergic to the test drug ingredients;
5. Subjects of childbearing potential who are unwilling to use highly effective
contraceptive methods;
6. Live vaccination was administered within 28 days prior to treatment
7. Known human immunodeficiency virus (HIV) infection or suggested active B or C
infection The following serologic status of hepatitis C virus infection: 1)
Hepatitis B virus (HBV) DNA positive. Positive hepatitis B surface antigen (HBsAg)
or anti-hepatitis B core antibody (HBcAb) seropositive if HBV DNA is undetectable
and willing to accept Monthly surveillance for HBV reactivation was eligible. 2)
Hepatitis C virus (HCV) antibody positive. For patients with HCV antibodies present,
if undetectable HCV RNA, can be included;
8. Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and
other organs
9. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12
months;
10. Any risk that is considered by the investigator to be likely to affect the safety of
the subjects or to pose a risk to the study And vital diseases, medical conditions,
or organ system insufficiency.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 20, 2024
Completion date:
December 30, 2029
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06427213
