Diffuse Large B-Cell LymphomaPhase 2NCT06764017
CHiR Therapy for Elderly DLBCL Intolerant to Chemo
A Phase 2 study testing CHiR-DEL in people with Diffuse Large B-Cell Lymphoma, run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial summary
The objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- CHiR-DEL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 1 Aug 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 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years;
- ECOG score of 0-3;
- Rated as unfit or frail on the simplified geriatric assessment (sGA);
- Histologically confirmed CD20-positive diffuse large B-cell lymphoma (diagnostic criteria according to WHO 2016), excluding transformed type 2 DLBCL;
- Immunohistochemically confirmed positive expression of MYC and BCL2 (MYC ≥ 40%, BCL2 ≥ 50% by immunohistochemistry);
- Previously untreated patients;
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- Cardiac, hepatic, and renal function: creatinine < 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase)/AST (aspartate aminotransferase) < 2.5 ULN; total bilirubin < 2 ULN;
- At least one measurable lesion;
- Unable to tolerate standard CHOP regimen chemotherapy or unwilling to receive chemotherapy;
- Adequate understanding and voluntary signing of the informed consent form. Exclusion Criteria：
- 1.Patients with central nervous system involvement at the time of onset; 2.Known human immunodeficiency virus (HIV) infection; 3.Pregnant or lactating women; 4.Other tumors requiring treatment; 5.Uncontrollable active infection; 6.Active hepatitis with HBV-DNA copy number not controlled within 21000/mL despite antiviral treatment; 7.Inability to understand, comply with the study protocol, or sign the informed consent form.
Who cannot join
None listed.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 3150101
Shaoying Chen, 1987951774@qq.com
About this study
Official title: A Single-arm, Multicenter, Prospective Clinical Study of CHiR (chidamide, Zanubrutinib, and Lenalidomide) for Newly Diagnosed MYC- and BCL2-positive Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy.
The objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- CHiR-DEL
- Keywords
- diffuse large B-cell lymphoma, MYC- and BCL2-positive, chidamide, zanubrutinib, lenalidomide, elderly patients
- 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.
CHiR-DELDrug
Using the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CHiR | Experimental | The combined regimen of chidamide, zanubrutinib, and lenalidomide (CHiR) is employed to treat elderly patients with double-expressor lymphoma. This study aims to explore the efficacy and safety of this regimen in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy. Receives: Drug: CHiR-DEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
the complete remission rate (CRR)
The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.
Measured: Each cycle consists of 21 days, with a total of 8 cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Aug 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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Lixia Sheng, First Affiliated Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764017
- Sponsor's protocol ID
- 2024-164A-02
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Prospective Clinical Study of CHiR (chidamide, Zanubrutinib, and Lenalidomide) for Newly Diagnosed MYC- and BCL2-positive Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy.
- ClinicalTrials.gov ID
- NCT06764017
- Acronym / sponsor ID
- 2024-164A-02
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- diffuse large B-cell lymphoma, MYC- and BCL2-positive, chidamide, zanubrutinib, lenalidomide, elderly patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 Jan 2025 (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 objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHiR | Experimental | Drug: CHiR-DELThe combined regimen of chidamide, zanubrutinib, and lenalidomide (CHiR) is employed to treat elderly patients with double-expressor lymphoma. This study aims to explore the efficacy and safety of this regimen in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age ≥ 70 years;
- ECOG score of 0-3;
- Rated as unfit or frail on the simplified geriatric assessment (sGA);
- Histologically confirmed CD20-positive diffuse large B-cell lymphoma (diagnostic criteria according to WHO 2016), excluding transformed type 2 DLBCL;
- Immunohistochemically confirmed positive expression of MYC and BCL2 (MYC ≥ 40%, BCL2 ≥ 50% by immunohistochemistry);
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CHiR-DELUsing the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy. | Drug | CHiR |
Primary outcome
the complete remission rate (CRR)
Time frame: Each cycle consists of 21 days, with a total of 8 cycles.
The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.
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 19 Mar 2025.
- 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.
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 CHiR-DEL in people with Diffuse Large B-Cell Lymphoma, run by First Affiliated Hospital of Ningbo 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 11 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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 Lixia Chief Physician (15968985233, slx800408@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the complete remission rate (CRR) (time frame: Each cycle consists of 21 days, with a total of 8 cycles.). 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 19 Mar 2025.