Untreated Mantle Cell LymphomaPhase 2NCT05504603
Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
A Phase 2 study testing zanubrutinib and rituximab, BEAM pretreatment and zanubrutinib maintenance in people with Untreated Mantle Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Untreated Mantle Cell Lymphoma
- What is being tested?
- zanubrutinib and rituximab, BEAM pretreatment and zanubrutinib maintenance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2020to 26 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histopathologically or Cytologically confirmed Mantle Cell Lymphoma(excluding indolent Mantle Cell Lymphoma) by the 2008 World Health Organization (WHO) Classification of diseases;
- Initial untreated patients;
- Age ≥ 18 years;
- ECOG score 0-2;
- 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;
- Patients must have measurable disease (i.e., ≥ 1.0 cm in lymph nodes diameter; or skin lesions assessed by physical examination);
- Written informed consent obtained from the subject.
Who cannot join
- Indolent Mantle Cell Lymphoma;
- Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal)
- Uncontrolled active infection, with the exception of tumor-related B symptom fever;
- Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
- Co-existence of other tumors;
- Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Zhengming Jin, +86 0512 67781856, jinzhengming519519@163.com
Changju Qu, +86 0512 67781856, qcj310@163.com
About this study
Official title: A Phase 2 Study of Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
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.
Read the 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.
- Conditions
- Untreated Mantle Cell Lymphoma
- Being tested
- zanubrutinib and rituximab, BEAM pretreatment, zanubrutinib maintenance
- Keywords
- Mantle Cell Lymphoma; Zanubrutinib; Rituximab; ASCT
- 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 rituximabDrug
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A
zanubrutinib and rituximabDrug
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1. Other name: Part B
BEAM pretreatmentDrug
semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6.
zanubrutinib maintenanceDrug
zanubrutinib 160mg PO BID.
| Study group | Role | What they receive |
|---|---|---|
| zanubrutinib(80mg), rituximab(100mg), ASCT | Experimental | 1. Phase I(Combined Immunotherapy Phase):
Part A(Induction Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1,8,15,22.
Part B(Consolidation Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1. Treatment cycles repeat every 28 days for 4 cycles.
2. Phase II(ASCT): BEAM pretreatment. Patients receive semustine on day1, etoposide on days 2-5, cytarabine on days 2-5 and melphalan on day 6.
3. Phase III(maintenance): Zanubrutinib Receives: Drug: zanubrutinib and rituximab; Drug: BEAM pretreatment; Drug: zanubrutinib maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate(ORR) in all patients
The rate of patients who achieved complete response and partial response after ZR combined immunotherapy
Measured: At the end of cycle 3 and cycle 5(each cycle is 28 days)
Complete Response Rate(CRR) in all patients
The rate of patients who achieved complete response after ZR combined immunotherapy.
Measured: At the end of cycle 3 and cycle 5(each cycle is 28 days)
Overall Response Rate(ORR) in patients received ASCT
The rate of patients who achieved complete response and partial response after ASCT.
Measured: 1 month after ASCT
Complete Response Rate(CRR) in patients received ASCT
The rate of patients who achieved complete response after ASCT.
Measured: 1 month after ASCT
Secondary outcomes (4)
Overall Survival (OS)
OS will be assessed from the first ZR given to date of death or end of follow-up.
Measured: up to 24 months after the last patient's enrollment.
Progression Free Survival (PFS)
PFS will be assessed from the first ZR given to date of progression, relapse, death or end of follow-up.
Measured: up to 24 months after the last patient's enrollment.
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events.
Measured: initiation of study drug until 30 days after last dose.
Minimal Residual Disease (MRD)
Measured: At the end of cycle 5 ZR (each cycle is 28 days) and 1 month after ASCT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start27 Jul 2020
- Primary completion26 Jul 2023 (estimated)
- Study completion26 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Untreated Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504603
- Sponsor's protocol ID
- Jinzm 004
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data would be available at the First Affiliated Hospital and other researchers after the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05504603
- Acronym / sponsor ID
- Jinzm 004
- Conditions
- Untreated Mantle Cell Lymphoma
- Keywords
- Mantle Cell Lymphoma; Zanubrutinib; Rituximab; ASCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 26 Jul 2023 (estimated)
- Study completion
- 26 Jul 2025 (estimated)
- First posted
- 17 Aug 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zanubrutinib(80mg), rituximab(100mg), ASCT | Experimental | Drug: zanubrutinib and rituximab, Drug: BEAM pretreatment, Drug: zanubrutinib maintenance1. Phase I(Combined Immunotherapy Phase): Part A(Induction Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1,8,15,22. Part B(Consolidation Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1. Treatment cycles repeat every 28 days for 4 cycles. 2. Phase II(ASCT): BEAM pretreatment. Patients receive semustine on day1, etoposide on days 2-5, cytarabine on days 2-5 and melphalan on day 6. 3. Phase III(maintenance): Zanubrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histopathologically or Cytologically confirmed Mantle Cell Lymphoma(excluding indolent Mantle Cell Lymphoma) by the 2008 World Health Organization (WHO) Classification of diseases;
- Initial untreated patients;
- Age ≥ 18 years;
- ECOG score 0-2;
- 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;
Key exclusion criteria (6 listed)
- Indolent Mantle Cell Lymphoma;
- Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal)
- Uncontrolled active infection, with the exception of tumor-related B symptom fever;
- Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
- Co-existence of other tumors;
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 rituximabzanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A | Drug | zanubrutinib(80mg), rituximab(100mg), ASCT |
| zanubrutinib and rituximabzanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1. Other name: Part B | Drug | zanubrutinib(80mg), rituximab(100mg), ASCT |
| BEAM pretreatmentsemustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6. | Drug | zanubrutinib(80mg), rituximab(100mg), ASCT |
| zanubrutinib maintenancezanubrutinib 160mg PO BID. | Drug | zanubrutinib(80mg), rituximab(100mg), ASCT |
Primary outcome
Overall Response Rate(ORR) in all patients
Time frame: At the end of cycle 3 and cycle 5(each cycle is 28 days)
The rate of patients who achieved complete response and partial response after ZR combined immunotherapy
Complete Response Rate(CRR) in all patients
Time frame: At the end of cycle 3 and cycle 5(each cycle is 28 days)
The rate of patients who achieved complete response after ZR combined immunotherapy.
Overall Response Rate(ORR) in patients received ASCT
Time frame: 1 month after ASCT
The rate of patients who achieved complete response and partial response after ASCT.
Complete Response Rate(CRR) in patients received ASCT
Time frame: 1 month after ASCT
The rate of patients who achieved complete response after ASCT.
4 secondary outcomes
Overall Survival (OS)
Time frame: up to 24 months after the last patient's enrollment.
Progression Free Survival (PFS)
Time frame: up to 24 months after the last patient's enrollment.
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
Time frame: initiation of study drug until 30 days after last dose.
Minimal Residual Disease (MRD)
Time frame: At the end of cycle 5 ZR (each cycle is 28 days) and 1 month after ASCT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Yes. All the data would be available at the First Affiliated Hospital and other researchers after the end of the study.
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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. This study is not recruiting at the moment.
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 rituximab, BEAM pretreatment and zanubrutinib maintenance in people with Untreated Mantle Cell Lymphoma, run by The First Affiliated Hospital of Soochow University 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengming Jin (+86 0512 67781856, jinzhengming519519@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate(ORR) in all patients (time frame: At the end of cycle 3 and cycle 5(each cycle is 28 days)). The study lists 4 primary outcomes in all. 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 17 Aug 2022.