Lymphoma, Mantle-CellPhase 2NCT06427213
This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
A Phase 2 study testing Zanubrutinib,Obinutuzumab and Zanubrutinib and R-BAC in people with Lymphoma, Mantle-Cell and Lymphoma, Non-Hodgkin, run by Henan Cancer Hospital.
Trial summary
This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin
- What is being tested?
- Zanubrutinib,Obinutuzumab and Zanubrutinib and R-BAC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 30 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL)
- The elderly group ≥65 years old;The young group was ≥18 years old and < 65 years old.
- ECOG Performance Status 0-3
- Life expectancy of at least 3 months
- At least one evaluable lesion according to 2014 Lugano criteria;
- 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%
Who cannot join
- The presence of other tumors could affect the study medication or interfere with the results;
- Patients require treatment with strong or moderate CYP3A inhibitors;
- Pregnant or lactating women;
- Known to be allergic to the test drug ingredients;
- Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods;
- Live vaccination was administered within 28 days prior to treatment
Show all 10Show fewer
- 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;
- Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and other organs
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.
Read the 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.
- Conditions
- Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin
- Being tested
- Zanubrutinib,Obinutuzumab, Zanubrutinib and R-BAC
- Keywords
- Zanubrutinib
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanubrutinib,ObinutuzumabDrug
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
Zanubrutinib and R-BACDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Elder Patients（≥65） | Experimental | Induction: Zanubrutinib and Obinutuzumab 1year
Maintenance: Zanubrutinib continued until progression Receives: Drug: Zanubrutinib,Obinutuzumab |
| Young Patients with High risk （≥18，<65） | Experimental | 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 Receives: Drug: Zanubrutinib and R-BAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response rate after induction
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: 3 yeas
Secondary outcomes (5)
Complete remission rate after Interim treatment
Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: 3 years
MRD negativity rate after induction
MRD negativity rate after induction treatment
Measured: 3 years
Progression free survival (PFS)
The time from start of treatment to progression or death from any cause
Measured: 5 years
Overall survival (OS)
The time from start of treatment to death from any cause
Measured: 5 years
Percentage of Participants With Adverse Events
Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start20 May 2024 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Mantle-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427213
- Sponsor's protocol ID
- IIT-TN MCL
- Status last verified
- Jan 2024
- First submitted
- 19 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06427213
- Acronym / sponsor ID
- IIT-TN MCL
- Conditions
- Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin
- Keywords
- Zanubrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elder Patients（≥65） | Experimental | Drug: Zanubrutinib,ObinutuzumabInduction: Zanubrutinib and Obinutuzumab 1year Maintenance: Zanubrutinib continued until progression |
| Young Patients with High risk （≥18，<65） | Experimental | Drug: Zanubrutinib and R-BACInduction: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL)
- The elderly group ≥65 years old;The young group was ≥18 years old and < 65 years old.
- ECOG Performance Status 0-3
- Life expectancy of at least 3 months
Key exclusion criteria (10 listed)
- The presence of other tumors could affect the study medication or interfere with the results;
- Patients require treatment with strong or moderate CYP3A inhibitors;
- Pregnant or lactating women;
- Known to be allergic to the test drug ingredients;
- Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zanubrutinib,ObinutuzumabZanubrutinib, 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 | Drug | Elder Patients（≥65） |
| Zanubrutinib and R-BACInduction: 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 | Drug | Young Patients with High risk （≥18，<65） |
Primary outcome
Objective Response rate after induction
Time frame: 3 yeas
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
5 secondary outcomes
Complete remission rate after Interim treatment
Time frame: 3 years
MRD negativity rate after induction
Time frame: 3 years
Progression free survival (PFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Percentage of Participants With Adverse Events
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib,Obinutuzumab and Zanubrutinib and R-BAC in people with Lymphoma, Mantle-Cell and Lymphoma, Non-Hodgkin, run by Henan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact keshu Zhou (0371-65587306, drzhouks77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response rate after induction (time frame: 3 yeas). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.