Diffuse Large B-cell Lymphoma (DLBCL)Phase 2NCT05596097
Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission
A Phase 2 study testing Zanubrutinib in people with Diffuse Large B-cell Lymphoma (DLBCL), run by LanZhou University at 1 site in China.
Trial summary
This trial is a single-center, single-arm, prospective clinical study to investigate the efficacy and safety of zanubrutinib maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL) in Initial remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma (DLBCL)
- What is being tested?
- Zanubrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2022to 30 Jul 2026
- 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
- Patients with DLBCL who are diagnosed according to the 2021 NCCN Guidelines for B-cell Lymphoma, aged ≥18 years;
- Don't received treatment;
- Measurable lesions: at least 1 lymph node lesion > 1.5 cm in longest dimension, or at least 1 extranodal lesion > 1.0 cm in longest dimension, and at least 2 measurable lesions accurately measured vertical diameter;
- Clinical stage II (not suitable for local radiotherapy), III, IV (Ann Arbor stage); Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Intermediate-high-risk /high-risk group: International Prognostic Index (IPI) score 3-5, aa-IPI score 2-3 or NCCN-IPI score ≥4;
- Expression of MYC, BCL-2 and BCL-6 (detected by immunohistochemistry, qualitative or quantitative detection), or MYD88, CD79A/CD79B [9] and TP53 genetic abnormality [10];
Show all 14Show fewer
- Patients with non-bone marrow invasion:
- The absolute value of neutrophils≥1.5×109/L
- Platelets ≥100×109/L (judged by the investigator according to the condition, the minimum can be ≥75×109/L)
- Hemoglobin ≥ 90g/L;
- 9. The level of biochemical indicators meets the following requirements:
- Renal function: endogenous creatinine clearance rate > 30ml/min;
- Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal range (ULN); total bilirubin ≤ 2 × ULN (unless Gilbert syndrome is diagnosed);
- Coagulation function: international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN; 9. life expectancy ≥ 3 months; 10. The patient and family members agree and sign an informed consent form.
Who cannot join
- Lymphoma with central nervous system invasion or mediastinal large B-cell lymphoma, diagnosis or treatment of malignant tumors other than DLBCL;
- Cannot tolerate zanubrutinib treatment, or have hypersensitivity reactions to any components of the study drug;
- Significant cardiovascular disease, including:
- Myocardial infarction within 6 months prior to screening;
- Unstable angina pectoris occurring within 3 months prior to screening;
- Clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
Show all 17Show fewer
- QTc (corrected by Fridericia formula): >450ms in men, >470ms in women, or other ECG abnormalities, including history of second-degree type II atrioventricular (AV) block or third-degree AV block;
- Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class;
- Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≤40% (AHA, 2022);
- Uncontrolled hypertension at screening, manifested as systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg on at least two consecutive blood pressure measurements;
- Requires continuous treatment with strong or moderate CYP3A inhibitors/inducers. Patients are not eligible if they have taken strong or moderate CYP3A inhibitors/inducers within 7 days prior to the first dose of study drug (or have taken these drugs for less than 5 half-lives);
- Hepatitis B virus (HBV-DNA) ≥ 1x10^3 copies/mL or HBV-DNA > 200 IU/mL or active hepatitis C virus (HCV), or human immunodeficiency virus (HIV) Serologically positive;
- Obvious bleeding tendency, such as a history of stroke, intracranial hemorrhage within 6 months, or a history of surgery within 4 weeks;
- Serious infectious diseases at the same time;
- Refuse to take reliable contraceptive methods during pregnancy, lactation or appropriate age;
- Participate in another clinical trial of lymphoma treatment at the same time;
- Unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Bei Liu, MD, +8613809319379, liubeiff@163.com
About this study
Official title: Clinical Research for Efficacy and Safety of Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission
This trial is a single-center, single-arm, prospective clinical study to investigate the efficacy and safety of zanubrutinib maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL) in Initial remission. The patients were divided into two categories: 1) Zanubrutinib maintenance therapy was started after R-CHOP induction and consolidation therapy reached maximum efficacy; 2) Initiate zanubrutinib maintenance therapy after maximal response to induction and consolidation therapy with or without rituximab (R-chemo). Therefore, the data in this study will reflect the efficacy and safety of zanubrutinib in the maintenance treatment of DLBCL patients with initial remission, and will provide new insights into the clinical application of zanubrutinib.
Read the detailed description
Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive malignant lymphoma, and because it is sensitive to chemotherapy, approximately 50% to 70% of patients can achieve a cure after first-line treatment. However, in recent years, it has been found that more than 30% of patients experience relapse within two years after first-line treatment, which is a serious health threat and requires urgent secondary treatment. To reduce the recurrence of DLBCL and improve the survival rate of patients, clinical researchers have long been dedicated to the maintenance treatment of DLBCL patients after first-line treatment, aiming to kill tumor cells and reduce the risk of recurrence through continuous drug administration, thus enabling patients to survive with the tumor for a long time. Several clinical trials are currently underway with rituximab, ibrutinib, lenalidomide, and thalidomide, but safer and more effective maintenance regimens have yet to be identified.
Zanubrutinib, a new-generation BTK inhibitor, is the first anti-tumor drug developed locally in China and approved for marketing in the US. Zanubrutinib inhibits the activation of the BCR signaling pathway by specifically binding to cysteine residues at the active site of BTK to form a covalent bond that irreversibly inactivates them, thereby inhibiting BTK and improving the tumor microenvironment, inhibiting malignant proliferation and inducing apoptosis in tumor B cells. Several clinical studies have demonstrated that ibrutinib alone and in combination is no less effective than ibrutinib in the treatment of DLBCL, and has a better safety and tolerability profile.
This study proposes to use Zanubrutinib for maintenance treatment in DLBCL patients in remission after primary treatment and to evaluate the efficacy and safety of patients to provide new insights into the clinical use of Zanubrutinib.
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL)
- Being tested
- Zanubrutinib
- Keywords
- Diffuse Large B-cell Lymphoma (DLBCL), Maintenance Therapy, Zanubrutinib, Rituximab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Zanubrutinib, 180mg, bid, p.o., d1-28; Treatment cycles every 28 days
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | According to the initial treatment plan of the patients, the patients were divided into R-CHOP and R-chemo groups. Both groups received zanubrutinib 160 mg bid p.o. d1-28 maintenance treatment for 12 months after induction and consolidation therapy reached the maximum efficacy. Receives: Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
EFS was defined as the time from initiation of zanubrutinib maintenance therapy to the occurrence of any event, including death, disease progression, change in chemotherapy regimen, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc. Whichever occurs first.
Measured: up to 36 months
Secondary outcomes (4)
Conversion rate of partial response (PR) to CR
the total proportion of patients who had a partial response to initial therapy converted to CR at any time point after starting zanubrutinib maintenance therapy and will be reported as converted to CR at 3, 6, 12 months, and any other time point.
Measured: up to 36 months
Progression-free survival (PFS)
PFS was defined as the duration from initiation of zanubrutinib maintenance therapy to disease progression, CR recurrence, or death, whichever occurred first.
Measured: up to 36 months
Overall survival (OS)
OS was defined as the duration from the date of initiation of zanubrutinib maintenance therapy to the date of death.
Measured: up to 36 months
adverse event
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Adverse events were assessed during 3, 6, and 12 months after the start of zanubrutinib maintenance therapy and 6, 12, and 24 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start30 Oct 2022 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B-cell Lymphoma (DLBCL)Studies 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
- Model description
- According to the initial treatment plan of the patients, the patients were divided into R-CHOP and R-chemo groups. Both groups received zanubrutinib maintenance therapy after induction and consolidation therapy reached the maximum curative effect. With event-free survival (EFS) as the primary endpoint, partial remission (PR) to CR conversion rate, progression-free survival (PFS), and overall survival (OS) as secondary endpoints, adverse events (AEs) were assessed. ) incidence and related mechanisms during the study period.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Collaborators
- BeOne Medicines
- Responsible party
- Principal investigator, Bei Liu, LanZhou University
- Investigators
- Bei Liu, MD, Principal investigator, The First Hospital of Lanzhou University,Lanzhou,Gansu,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596097
- Sponsor's protocol ID
- ZEBUBU22
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the completion of the clinical trial, we will choose whether to disclose the result according to the relevant regulations of the Chinese Genetic Office.
Publications
Maurer MJ, Ghesquieres H, Jais JP, Witzig TE, Haioun C, Thompson CA, Delarue R, Micallef IN, Peyrade F, Macon WR, Jo Molina T, Ketterer N, Syrbu SI, Fitoussi O, Kurtin PJ, Allmer C, Nicolas-Virelizier E, Slager SL, Habermann TM, Link BK, Salles G, Tilly H, Cerhan JR. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014 Apr 1;32(10):1066-73. doi: 10.1200/JCO.2013.51.5866. Epub 2014 Feb 18.
PubMed 24550425Yuan T, Zhang F, Yao Q, Liu Y, Zhu X, Chen P. Maintenance therapy for untreated diffuse large B-cell lymphoma: a systematic review and network meta-analysis. Ther Adv Hematol. 2021 May 29;12:20406207211018894. doi: 10.1177/20406207211018894. eCollection 2021.
PubMed 34104373Pal Singh S, Dammeijer F, Hendriks RW. Role of Bruton's tyrosine kinase in B cells and malignancies. Mol Cancer. 2018 Feb 19;17(1):57. doi: 10.1186/s12943-018-0779-z.
PubMed 29455639Tam CS, Opat S, D'Sa S, Jurczak W, Lee HP, Cull G, Owen RG, Marlton P, Wahlin BE, Sanz RG, McCarthy H, Mulligan S, Tedeschi A, Castillo JJ, Czyz J, Fernandez de Larrea C, Belada D, Libby E, Matous JV, Motta M, Siddiqi T, Tani M, Trneny M, Minnema MC, Buske C, Leblond V, Trotman J, Chan WY, Schneider J, Ro S, Cohen A, Huang J, Dimopoulos M. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: the ASPEN study. Blood. 2020 Oct 29;136(18):2038-2050. doi: 10.1182/blood.2020006844.
PubMed 32731259Byrd JC, Furman RR, Coutre SE, Burger JA, Blum KA, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Shaw Y, Bilotti E, Zhou C, James DF, O'Brien S. Three-year follow-up of treatment-naive and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood. 2015 Apr 16;125(16):2497-506. doi: 10.1182/blood-2014-10-606038. Epub 2015 Feb 19.
PubMed 25700432Phillips T, Chan H, Tam CS, Tedeschi A, Johnston P, Oh SY, Opat S, Eom HS, Allewelt H, Stern JC, Tan Z, Novotny W, Huang J, Trotman J. Zanubrutinib monotherapy in relapsed/refractory indolent non-Hodgkin lymphoma. Blood Adv. 2022 Jun 14;6(11):3472-3479. doi: 10.1182/bloodadvances.2021006083.
PubMed 35390135
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research for Efficacy and Safety of Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission
- ClinicalTrials.gov ID
- NCT05596097
- Acronym / sponsor ID
- ZEBUBU22
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL)
- Keywords
- Diffuse Large B-cell Lymphoma (DLBCL), Maintenance Therapy, Zanubrutinib, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Collaborators
- BeOne Medicines
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 27 Oct 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.
This trial is a single-center, single-arm, prospective clinical study to investigate the efficacy and safety of zanubrutinib maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL) in Initial remission. The patients were divided into two categories: 1) Zanubrutinib maintenance therapy was started after R-CHOP induction and consolidation therapy reached maximum efficacy; 2) Initiate zanubrutinib maintenance therapy after maximal response to induction and consolidation therapy with or without rituximab (R-chemo). Therefore, the data in this study will reflect the efficacy and safety of zanubrutinib in the maintenance treatment of DLBCL patients with initial remission, and will provide new insights into the clinical application of zanubrutinib.
Detailed description
Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive malignant lymphoma, and because it is sensitive to chemotherapy, approximately 50% to 70% of patients can achieve a cure after first-line treatment. However, in recent years, it has been found that more than 30% of patients experience relapse within two years after first-line treatment, which is a serious health threat and requires urgent secondary treatment. To reduce the recurrence of DLBCL and improve the survival rate of patients, clinical researchers have long been dedicated to the maintenance treatment of DLBCL patients after first-line treatment, aiming to kill tumor cells and reduce the risk of recurrence through continuous drug administration, thus enabling patients to survive with the tumor for a long time. Several clinical trials are currently underway with rituximab, ibrutinib, lenalidomide, and thalidomide, but safer and more effective maintenance regimens have yet to be identified.
Zanubrutinib, a new-generation BTK inhibitor, is the first anti-tumor drug developed locally in China and approved for marketing in the US. Zanubrutinib inhibits the activation of the BCR signaling pathway by specifically binding to cysteine residues at the active site of BTK to form a covalent bond that irreversibly inactivates them, thereby inhibiting BTK and improving the tumor microenvironment, inhibiting malignant proliferation and inducing apoptosis in tumor B cells. Several clinical studies have demonstrated that ibrutinib alone and in combination is no less effective than ibrutinib in the treatment of DLBCL, and has a better safety and tolerability profile.
This study proposes to use Zanubrutinib for maintenance treatment in DLBCL patients in remission after primary treatment and to evaluate the efficacy and safety of patients to provide new insights into the clinical use of Zanubrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- According to the initial treatment plan of the patients, the patients were divided into R-CHOP and R-chemo groups. Both groups received zanubrutinib maintenance therapy after induction and consolidation therapy reached the maximum curative effect. With event-free survival (EFS) as the primary endpoint, partial remission (PR) to CR conversion rate, progression-free survival (PFS), and overall survival (OS) as secondary endpoints, adverse events (AEs) were assessed. ) incidence and related mechanisms during the study period.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: ZanubrutinibAccording to the initial treatment plan of the patients, the patients were divided into R-CHOP and R-chemo groups. Both groups received zanubrutinib 160 mg bid p.o. d1-28 maintenance treatment for 12 months after induction and consolidation therapy reached the maximum efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with DLBCL who are diagnosed according to the 2021 NCCN Guidelines for B-cell Lymphoma, aged ≥18 years;
- Don't received treatment;
- Measurable lesions: at least 1 lymph node lesion > 1.5 cm in longest dimension, or at least 1 extranodal lesion > 1.0 cm in longest dimension, and at least 2 measurable lesions accurately measured vertical diameter;
- Clinical stage II (not suitable for local radiotherapy), III, IV (Ann Arbor stage); Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Intermediate-high-risk /high-risk group: International Prognostic Index (IPI) score 3-5, aa-IPI score 2-3 or NCCN-IPI score ≥4;
Key exclusion criteria (17 listed)
- Lymphoma with central nervous system invasion or mediastinal large B-cell lymphoma, diagnosis or treatment of malignant tumors other than DLBCL;
- Cannot tolerate zanubrutinib treatment, or have hypersensitivity reactions to any components of the study drug;
- Significant cardiovascular disease, including:
- Requires continuous treatment with strong or moderate CYP3A inhibitors/inducers. Patients are not eligible if they have taken strong or moderate CYP3A inhibitors/inducers within 7 days prior to the first dose of study drug (or have taken these drugs for less than 5 half-lives);
- Hepatitis B virus (HBV-DNA) ≥ 1x10^3 copies/mL or HBV-DNA > 200 IU/mL or active hepatitis C virus (HCV), or human immunodeficiency virus (HIV) Serologically positive;
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 |
|---|---|---|
| ZanubrutinibZanubrutinib, 180mg, bid, p.o., d1-28; Treatment cycles every 28 days | Drug | experimental group |
Primary outcome
Event-free survival (EFS)
Time frame: up to 36 months
EFS was defined as the time from initiation of zanubrutinib maintenance therapy to the occurrence of any event, including death, disease progression, change in chemotherapy regimen, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc. Whichever occurs first.
4 secondary outcomes
Conversion rate of partial response (PR) to CR
Time frame: up to 36 months
Progression-free survival (PFS)
Time frame: up to 36 months
Overall survival (OS)
Time frame: up to 36 months
adverse event
Time frame: Adverse events were assessed during 3, 6, and 12 months after the start of zanubrutinib maintenance therapy and 6, 12, and 24 months after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 24550425Maurer MJ, Ghesquieres H, Jais JP, Witzig TE, Haioun C, Thompson CA, Delarue R, Micallef IN, Peyrade F, Macon WR, Jo Molina T, Ketterer N, Syrbu SI, Fitoussi O, Kurtin PJ, Allmer C, Nicolas-Virelizier E, Slager SL, Habermann TM, Link BK, Salles G, Tilly H, Cerhan JR. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014 Apr 1;32(10):1066-73. doi: 10.1200/JCO.2013.51.5866. Epub 2014 Feb 18.
- Background: PubMed 34104373Yuan T, Zhang F, Yao Q, Liu Y, Zhu X, Chen P. Maintenance therapy for untreated diffuse large B-cell lymphoma: a systematic review and network meta-analysis. Ther Adv Hematol. 2021 May 29;12:20406207211018894. doi: 10.1177/20406207211018894. eCollection 2021.
- Background: PubMed 29455639Pal Singh S, Dammeijer F, Hendriks RW. Role of Bruton's tyrosine kinase in B cells and malignancies. Mol Cancer. 2018 Feb 19;17(1):57. doi: 10.1186/s12943-018-0779-z.
- Background: PubMed 32731259Tam CS, Opat S, D'Sa S, Jurczak W, Lee HP, Cull G, Owen RG, Marlton P, Wahlin BE, Sanz RG, McCarthy H, Mulligan S, Tedeschi A, Castillo JJ, Czyz J, Fernandez de Larrea C, Belada D, Libby E, Matous JV, Motta M, Siddiqi T, Tani M, Trneny M, Minnema MC, Buske C, Leblond V, Trotman J, Chan WY, Schneider J, Ro S, Cohen A, Huang J, Dimopoulos M. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: the ASPEN study. Blood. 2020 Oct 29;136(18):2038-2050. doi: 10.1182/blood.2020006844.
- Background: PubMed 25700432Byrd JC, Furman RR, Coutre SE, Burger JA, Blum KA, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Shaw Y, Bilotti E, Zhou C, James DF, O'Brien S. Three-year follow-up of treatment-naive and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood. 2015 Apr 16;125(16):2497-506. doi: 10.1182/blood-2014-10-606038. Epub 2015 Feb 19.
- Background: PubMed 35390135Phillips T, Chan H, Tam CS, Tedeschi A, Johnston P, Oh SY, Opat S, Eom HS, Allewelt H, Stern JC, Tan Z, Novotny W, Huang J, Trotman J. Zanubrutinib monotherapy in relapsed/refractory indolent non-Hodgkin lymphoma. Blood Adv. 2022 Jun 14;6(11):3472-3479. doi: 10.1182/bloodadvances.2021006083.
- Individual participant dataSharing planned: No. After the completion of the clinical trial, we will choose whether to disclose the result according to the relevant regulations of the Chinese Genetic Office.
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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.
Bei Liu, MD principal investigator
The First Hospital of Lanzhou University,Lanzhou,Gansu,China
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 in people with Diffuse Large B-cell Lymphoma (DLBCL), run by LanZhou 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 14 inclusion and 17 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 27 Oct 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 Bei Liu, MD (+86 13809319379, liubeiff@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05596097, which also lists 6 linked publications.
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 27 Oct 2022.