Diffuse Large B-cell Lymphoma RecurrentPhase 2NCT06033820
Zanubrutinib+Lenalidomide+R-ICE in Relapsed/Refractory DLBCL
A Phase 2 study testing ZR2-ICE in people with Diffuse Large B-cell Lymphoma Recurrent and Diffuse Large B Cell Lymphoma Refractory, run by RenJi Hospital at 1 site in China.
Trial summary
This is a prospective, single center, single arm, open label study of zanubrutinib, lenalidomide in combination with Rituximab-ICE for treatment of relapsed/refractory diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma Recurrent, Diffuse Large B Cell Lymphoma Refractory
- What is being tested?
- ZR2-ICE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2023to 30 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age between 18 years and 75 years 2. Histologically confirmed diagnosis of DLBCL, CD20 positive 3. Patients received at least one systemic regimens for the treatment of DLBCL, and one therapy line must have included a CD20-targeted therapy.
- 4. Relapsed or refractory disease 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Measurable disease on cross section imaging by PET and/or CT that is at least 1.5 cm in the longest diameter and measurable in two perpendicular dimensions as defined by IWG criteria.
- 7. Patients must meet the following laboratory criteria at screening, including:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L or ≥0.75 x 109/L if bone marrow involvement
- Platelets ≥90 x 109/L or ≥50 x 109/L if bone marrow involvement
- Hemoglobin ≥75 g/dL or ≥50 g/dL if bone marrow involvement
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- Total bilirubin ≤2.5 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of hepatic involvement.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤3 x (ULN) or < 5 x ULN if hepatic involvement.
- Creatinine Clearance Rate ≥60 mL/min.
- INR ≤1.5 x ULN and aPTT ≤1.5 x ULN 8. Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study. 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. For females, these restrictions apply for 3 month after the last dose of study drug.
- 9. Male subject agrees to use an acceptable method for contraception for the duration of the study. Men must agree to not donate sperm during and after the study. For males, these restrictions apply for 3 months after the last dose of study drug.
- 10. Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study. Must be able to adhere to study visit schedules and other protocol requirements.
Who cannot join
- 1. Patients who have a history of "double/triple hit" genetics. 2. Patients who have, within 14 days prior to Day 1 dosing:
- not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy.
- undergone major surgery or suffered from significant traumatic injury.
- received live vaccines.
- required parenteral antimicrobial therapy for active, intercurrent infections. 3. Patients who have use investigational agents within the period ≤ 3 months prior to Day 1 dosing.
- 4. Patients who have,
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- Adverse events (AEs) due to previous anti-tumor therapy have not recovered
- Known allergy or sensitivity to any drug contained in the regimen
- have undergone ASCT within the period ≤3 months prior to signing the informed consent form.
- have undergone previous allogenic stem cell transplantation.
- have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
- concurrently use other anticancer or experimental treatments. 5. Coexistent second malignancy or history of prior malignancy within previous 5 years.
- 6. Patients who have,
- Known history of active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
- Known history of human immunodeficiency virus (HIV) infection.
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- History of gastrointestinal disorder or defect that would interfere with the absorption of the study drug.
- Patients with history of severe hemorrhagic disorders.
- History of stroke or intracranial hemorrhage within 6 months prior to registration
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Honghui Huang, MD, honghui_huang@163.com
Honghui Huang, MD
About this study
Official title: A Prospective, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of Zanubrutinib, Lenalidomide With R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma.
This is a prospective, single center, single arm, open label study of zanubrutinib, lenalidomide in combination with Rituximab-ICE for treatment of relapsed/refractory diffuse large B-cell lymphoma.
- Being tested
- ZR2-ICE
- Keywords
- diffuse large B-cell lymphoma, Zanubrutinib, Lenalidomide, Salvage therapy
- 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.
ZR2-ICEDrug
- Drug: zanubrutinib Oral Capsule
- Drug: lenalidomide Oral Capsule
- Drug: R-ICE chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| ZR2-ICE Group | Experimental | All patients will receive 3 cycles of ZR2-ICE immunochemotherapy every three weeks. Receives: Drug: ZR2-ICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
To evaluate the efficacy in terms of objective response rate including CR and PR rate after three cycles of ZR2-ICE
Measured: 9 weeks
Secondary outcomes (5)
Complete remission rate (CR)
To evaluate the efficacy in terms of Complete Response Rate after three cycles of ZR2-ICE
Measured: 9 weeks
DOR
Among participants who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression
Measured: Up to 2 years
Progression-free survival
Progression-free survival is defined as the time from enrolment to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.
Measured: Up to 2 years
Overall survival
Overall survival is defined as the time from enrolment to death due to any cause.
Measured: Up to 2 years
Safety Management Study
Incidence of Treatment-Emergent Adverse Events
Measured: Up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start12 Oct 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (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 Lymphoma RecurrentStudies of the same condition, open and under way.
- More trials run by RenJi 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033820
- Sponsor's protocol ID
- IIT-2022-0229
- Status last verified
- Mar 2024
- First submitted
- 5 Sep 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of Zanubrutinib, Lenalidomide With R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT06033820
- Acronym / sponsor ID
- IIT-2022-0229
- Keywords
- diffuse large B-cell lymphoma, Zanubrutinib, Lenalidomide, Salvage therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Sep 2023 (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 prospective, single center, single arm, open label study of zanubrutinib, lenalidomide in combination with Rituximab-ICE for treatment of relapsed/refractory diffuse large B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZR2-ICE Group | Experimental | Drug: ZR2-ICEAll patients will receive 3 cycles of ZR2-ICE immunochemotherapy every three weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Age between 18 years and 75 years 2. Histologically confirmed diagnosis of DLBCL, CD20 positive 3. Patients received at least one systemic regimens for the treatment of DLBCL, and one therapy line must have included a CD20-targeted therapy.
- 4. Relapsed or refractory disease 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Measurable disease on cross section imaging by PET and/or CT that is at least 1.5 cm in the longest diameter and measurable in two perpendicular dimensions as defined by IWG criteria.
- Absolute neutrophil count (ANC) ≥1.5 x 109/L or ≥0.75 x 109/L if bone marrow involvement
- Platelets ≥90 x 109/L or ≥50 x 109/L if bone marrow involvement
- Hemoglobin ≥75 g/dL or ≥50 g/dL if bone marrow involvement
Key exclusion criteria (19 listed)
- 1. Patients who have a history of "double/triple hit" genetics. 2. Patients who have, within 14 days prior to Day 1 dosing:
- not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy.
- undergone major surgery or suffered from significant traumatic injury.
- received live vaccines.
- required parenteral antimicrobial therapy for active, intercurrent infections. 3. Patients who have use investigational agents within the period ≤ 3 months prior to Day 1 dosing.
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 |
|---|---|---|
| ZR2-ICE* Drug: zanubrutinib Oral Capsule * Drug: lenalidomide Oral Capsule * Drug: R-ICE chemotherapy | Drug | ZR2-ICE Group |
Primary outcome
Objective response rate (ORR)
Time frame: 9 weeks
To evaluate the efficacy in terms of objective response rate including CR and PR rate after three cycles of ZR2-ICE
5 secondary outcomes
Complete remission rate (CR)
Time frame: 9 weeks
DOR
Time frame: Up to 2 years
Progression-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Safety Management Study
Time frame: Up to 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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 ZR2-ICE in people with Diffuse Large B-cell Lymphoma Recurrent and Diffuse Large B Cell Lymphoma Refractory, run by RenJi 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 12 inclusion and 19 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 13 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong-Hui Huang, Professor (00862168383144, huanghonghui@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 9 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 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.