Diffuse Large B Cell LymphomaPhase 2NCT06669143
Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial Remission
A Phase 2 study testing Zanubrutinib and Lenalidomide in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital.
Trial summary
This single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Zanubrutinib and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients were informed about this study and voluntarily signed written informed consent
- Patients were intolerant first-line intensive chemotherapy, including R-CHOP or R-DA-EPOCH: a) age≧70 years, or unfit or frail according to CGA; b) ECOG 0-2; c) measurable lesions
- DLBCL with initial CR/PR according to 2016 WHO Classification of Tumor of Haematopoietic and Lymphoid Tissues
- Life expectancy > 3 months
- Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN;
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [Beta-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
Who cannot join
- Contraindication to any drug in the study
- Seropositive for or active viral infection with HBV or HCV
- Human immunodeficiency virus (HIV) infection
- Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class;
- QTc (corrected by Fridericia formula): >480ms;
- Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
- If female, the patient is pregnant or breast-feeding
- Any uncontrolled active systemic infection
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: The Efficacy and Safety of Zanubutinib-based for Post-remission Maintenance in Patients With Diffuse Large B-cell Lymphoma Who Are Intolerant to Intense First-line Chemotherapy
This single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Zanubrutinib, Lenalidomide
- Keywords
- DLBCL, zanubrutinib, maintenance
- 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
160 mg bid, po, day 1-21, a maximum of 2 years.
LenalidomideDrug
25 mg qd, po, day 1-10, a maximum of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib and Lenalidomide | Experimental | Not described Receives: Drug: Zanubrutinib; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival
Measured: 2 years after enrollment
Secondary outcomes (3)
Overall survival
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Measured: From enrollment to study completion, a maximum of 4.5 years
Overall response rate
ORR at treatment completion or discontinuation defined as the proportion of participants with partial response (PR) or CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC(separately)
Measured: up to 2 year, at the end of maintenance
Complete response rate
CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC (separately)
Measured: up to 2 year, at the end of maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669143
- Sponsor's protocol ID
- zanubrutinib-based maintenance
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 1 Nov 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Zanubutinib-based for Post-remission Maintenance in Patients With Diffuse Large B-cell Lymphoma Who Are Intolerant to Intense First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT06669143
- Acronym / sponsor ID
- zanubrutinib-based maintenance
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- DLBCL, zanubrutinib, maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Nov 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 single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy.
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 Lenalidomide | Experimental | Drug: Zanubrutinib, Drug: Lenalidomide |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients were informed about this study and voluntarily signed written informed consent
- Patients were intolerant first-line intensive chemotherapy, including R-CHOP or R-DA-EPOCH: a) age≧70 years, or unfit or frail according to CGA; b) ECOG 0-2; c) measurable lesions
- DLBCL with initial CR/PR according to 2016 WHO Classification of Tumor of Haematopoietic and Lymphoid Tissues
- Life expectancy > 3 months
- Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN;
Key exclusion criteria (8 listed)
- Contraindication to any drug in the study
- Seropositive for or active viral infection with HBV or HCV
- Human immunodeficiency virus (HIV) infection
- Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class;
- QTc (corrected by Fridericia formula): >480ms;
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 |
|---|---|---|
| Zanubrutinib160 mg bid, po, day 1-21, a maximum of 2 years. | Drug | Zanubrutinib and Lenalidomide |
| Lenalidomide25 mg qd, po, day 1-10, a maximum of 2 years. | Drug | Zanubrutinib and Lenalidomide |
Primary outcome
2-year recurrence-free survival
Time frame: 2 years after enrollment
3 secondary outcomes
Overall survival
Time frame: From enrollment to study completion, a maximum of 4.5 years
Overall response rate
Time frame: up to 2 year, at the end of maintenance
Complete response rate
Time frame: up to 2 year, at the end of maintenance
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 1 Nov 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 and Lenalidomide in people with Diffuse Large B Cell Lymphoma, run by Ruijin 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 6 inclusion and 8 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 1 Nov 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 Weili Zhao, M.D. and Ph.D (021-64370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival (time frame: 2 years after enrollment). 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 1 Nov 2024.