Mantle Cell LymphomaPhase 2Z+RCHOP/RDHAPNCT06255704
A Single-arm, Single-center, Open-label Phase II Study of Zanubrutinib Combined With R-CHOP/R-DHAP in Newly Diagnosed Mantle CellLymphoma Patients
A Phase 2 study testing Zanubrutinib and RCHOP/RDHAP in people with Mantle Cell Lymphoma, run by Shanxi Province Cancer Hospital at 1 site in China.
Trial summary
Evaluation the efficacy and safety of Zanubrutinib + R-CHOP/R-DHAP for the treatment mantle cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Zanubrutinib and RCHOP/RDHAP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 1 Dec 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of MCL according to WHO classification;
- Previously untreated MCL.
- Age ≥ 18 and ≤ 70 years old.
- ECOG, 0~2.
- Suitable for high-dose treatment including high-dose Ara-C.
- Stage II-IV (Ann Arbor).
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- 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.
- The following laboratory tests during the screening period (unless related to MCL disease)
- 1) Neutrophils ≥1×109/L within 7 days prior to study entry, and no growth factor support therapy.
- 2) Platelets ≥75×109/L within 7 days prior to study entry without growth factor support or blood transfusion.
- 3) Hemoglobin ≥75g/L shall not be transfused within 7 days before the test. If bone marrow is involved, neutrophils ≥0.75×109/L, platelets ≥50×109/L, hemoglobin ≥50g/L)
- 4) Creatinine clearance ≥30ml/min
- 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× upper limit of normal (ULN).
- International Standardized ratio (INR) ≤1.5 and activated partial prothrombin kinase time (APTT) ≤1.5×ULN. If there is a clotting factor inhibitor that causes an elevated INR or prolonged APTT, it is up to the investigator to decide whether to enroll the patient.
- 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 > 3 months.
- Written informed consent form according to GCP and national regulations.
Who cannot join
- Known CNS involvement of MCL, Leukemic non-lymphonodular mantle cell lymphoma was excluded.
- Major surgery within 4 weeks of screening
- 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)
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- 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
- Active infection including infections requiring oral or intravenous antimicrobial therapy
- Patients with unresolved hepatitis B or C infection or known HIV positive infection
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
- Pregnancy or lactation
- 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
- Participation in another clinical trial within 30 days before enrollment in this study
- poor compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Hematology Department of ShanXi Cancer Hospital
Taiyuan, Shanxi, 030013
About this study
Official title: A Single-arm, Single-center, Open-label Phase II Study of Zanubrutnib Combined With R-CHOP/R-DHAP Alternating Regimen for First-line MCL and Followed by Zanubrutinib Rituximab Maintenance Therapy
Evaluation the efficacy and safety of Zanubrutinib + R-CHOP/R-DHAP for the treatment mantle cell lymphoma.
Read the detailed description
A single-arm, single-center, open-label phase II study of Zanubrutinib combined with R-CHOP/R-DHAP alternating induction therapy followed by Zanubrutinib rituximab maintenance therapy.The primary objective of this study was to assess CR and ORR rates after 6 cycles of initiation (i.e., at the end of induction therapy), and to collect adverse events during induction and maintenance therapy.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Zanubrutinib and RCHOP/RDHAP
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanubrutinib and RCHOP/RDHAPDrug
Alternating 3× R-CHOP/ 3× R-DHAOx, every 21 days plus oral Zanubrutinib in cycle 1, 3, 5 in combination with R-CHOP:
R-CHOP (cycle 1,3,5):
Rituximab 375 mg/m2 D1, I.V. Cyclophosphamide 750 mg/m2 D1, I.V. Doxorubicine 50 mg/m2 D1, I.V. Vincristine 1.4mg/m2(max 2mg)D1, I.V. Prednisone 100mg D1-5, oral Zanubrutinib 160mg BID D1-21, oral
R-DHAP(cycle 2,4,6):
Dexamethasone 40mg D1-4 oral/I.V. Rituximab 375mg/m2 D1, I.V. Ara-C 2×2g/m2 q12h D2, I.V. Cisplatin 100mg/m2 D1, I.V.
Maintenance:
Zanubrutinib, 160mg PO BID, rituximab 375mg/m2 repeated every 8 weeks, treatment will continue for up to 2 years or until progressive disease。
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib and RCHOP/RDHAP | Experimental | Patients will receive zanubrutinib and RCHOP alternating with RDHAP for a total of 6 cycles of induction therapy, and patients who achieve complete response after 6 cycles of induction therapy will be eligible to enter a 2-year maintenance treatment period of zanubrutinib in combination with rituximab Receives: Drug: Zanubrutinib and RCHOP/RDHAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate after 6 cycles of induction therapy
To evaluate the CR rate after Zanubrutinib-based induction therapy in subjects with newly diagnosed MCL.
Measured: 18 weeks
Secondary outcomes (5)
ORR rate after 6 cycles of induction therapy
To evaluate the ORR rate after Zanubrutinib-based induction therapy in subjects with newly diagnosed MCL.
Measured: 18 weeks
Progression free survival (PFS)
The time from start of treatment to progression or death from any cause
Measured: 60 weeks
Overall survival (OS)
The time from start of treatment to death from any cause
Measured: 60 weeks
duration of response, DOR
Defined as the time after the start of treatment from the first time remission criteria are met until disease progression or death is objectively recorded, whichever occurs first.
Measured: 60 weeks
MRD negative rate at the end of induction therapy
MRD negative rate in peripheral blood or bone marrow at the end of induction therapy
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start15 Mar 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Province Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liping Su, M.D., Principal investigator, Hematology Department of ShanXi Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255704
- Sponsor's protocol ID
- MCL BTKi immunochemotherapy
- Acronym
- Z+RCHOP/RDHAP
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to Share Clinical Study Report within six months after the study completed
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Open-label Phase II Study of Zanubrutnib Combined With R-CHOP/R-DHAP Alternating Regimen for First-line MCL and Followed by Zanubrutinib Rituximab Maintenance Therapy
- ClinicalTrials.gov ID
- NCT06255704
- Acronym / sponsor ID
- Z+RCHOP/RDHAP / MCL BTKi immunochemotherapy
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Shanxi Province Cancer HospitalUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 13 Feb 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.
Evaluation the efficacy and safety of Zanubrutinib + R-CHOP/R-DHAP for the treatment mantle cell lymphoma.
Detailed description
A single-arm, single-center, open-label phase II study of Zanubrutinib combined with R-CHOP/R-DHAP alternating induction therapy followed by Zanubrutinib rituximab maintenance therapy.The primary objective of this study was to assess CR and ORR rates after 6 cycles of initiation (i.e., at the end of induction therapy), and to collect adverse events during induction and maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib and RCHOP/RDHAP | Experimental | Drug: Zanubrutinib and RCHOP/RDHAPPatients will receive zanubrutinib and RCHOP alternating with RDHAP for a total of 6 cycles of induction therapy, and patients who achieve complete response after 6 cycles of induction therapy will be eligible to enter a 2-year maintenance treatment period of zanubrutinib in combination with rituximab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed diagnosis of MCL according to WHO classification;
- Previously untreated MCL.
- Age ≥ 18 and ≤ 70 years old.
- ECOG, 0~2.
- Suitable for high-dose treatment including high-dose Ara-C.
Key exclusion criteria (15 listed)
- Known CNS involvement of MCL, Leukemic non-lymphonodular mantle cell lymphoma was excluded.
- Major surgery within 4 weeks of screening
- 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
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 and RCHOP/RDHAPAlternating 3× R-CHOP/ 3× R-DHAOx, every 21 days plus oral Zanubrutinib in cycle 1, 3, 5 in combination with R-CHOP: R-CHOP (cycle 1,3,5): Rituximab 375 mg/m2 D1, I.V. Cyclophosphamide 750 mg/m2 D1, I.V. Doxorubicine 50 mg/m2 D1, I.V. Vincristine 1.4mg/m2(max 2mg)D1, I.V. Prednisone 100mg D1-5, oral Zanubrutinib 160mg BID D1-21, oral R-DHAP(cycle 2,4,6): Dexamethasone 40mg D1-4 oral/I.V. Rituximab 375mg/m2 D1, I.V. Ara-C 2×2g/m2 q12h D2, I.V. Cisplatin 100mg/m2 D1, I.V. Maintenance: Zanubrutinib, 160mg PO BID, rituximab 375mg/m2 repeated every 8 weeks, treatment will continue for up to 2 years or until progressive disease。 | Drug | Zanubrutinib and RCHOP/RDHAP |
Primary outcome
CR rate after 6 cycles of induction therapy
Time frame: 18 weeks
To evaluate the CR rate after Zanubrutinib-based induction therapy in subjects with newly diagnosed MCL.
5 secondary outcomes
ORR rate after 6 cycles of induction therapy
Time frame: 18 weeks
Progression free survival (PFS)
Time frame: 60 weeks
Overall survival (OS)
Time frame: 60 weeks
duration of response, DOR
Time frame: 60 weeks
MRD negative rate at the end of induction therapy
Time frame: 18 weeks
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 13 Feb 2024.
- Individual participant dataSharing planned: Yes. Plan to Share Clinical Study Report within six months after the study completed
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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.
Liping Su, M.D. principal investigator
Hematology Department of ShanXi Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib and RCHOP/RDHAP in people with Mantle Cell Lymphoma, run by Shanxi Province Cancer Hospital at 1 site in China.
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 17 inclusion and 15 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Liping Su, M.D. (13835158122 ext. +86, sulp2005@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate after 6 cycles of induction therapy (time frame: 18 weeks). 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 13 Feb 2024.