Double Express Diffuse Large B-cell LymphomaPhase 2NCT05527912
A Phase II Study of Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy
A Phase 2 study testing Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy in people with Double Express Diffuse Large B-cell Lymphoma, run by Sun Yat-sen University at 2 sites in China.
Trial summary
This phase II trial studies how well giving rituximab,chidamide, and zanubrutinib with Sequential chemotherapy works in treating patients with double express diffuse large B-cell lymphoma. The prognosis of patients with DEL-DLBCL is usually worse than that of ordinary DLBCL. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Double Express Diffuse Large B-cell Lymphoma
- What is being tested?
- Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- 24 Feb 2023to 1 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed dual-expression diffuse large B-cell lymphoma (DLBCL) with IHC BCL2 expression ≥50% and MYC expression ≥40%.
- Male or female patients: 18-65 years old.
- ECOG physical status score: 0~2 points.
- Estimated survival time ≥6 months.
- There must be at least 1 evaluable or measurable lesion that meets Lugano 2014 criteria [ evaluable lesion : 18F-fluorodeoxyglucose/Positron Emission Tomography (18FDG/PET) examination showed elevated lymph node or extranodal local uptake (higher than liver) and PET and/or Computed Tomography (CT) features consistent with lymphoma. Measurable lesion : Nodules >15mm or extranodal lesions >10mm with increased 18FDG uptake]. The absence of measurable lesions and increased diffuse hepatic uptake of 18FDG should be excluded.
- Major organ function was good, that is, the following requirements should be met one week before enrollment: blood routine, WBC≥3×10*9/L, Hb≥80g/L,PLT≥80×10*9/L; The heart and liver functions were normal (TBIL≤1.5ULN, ALT and AST ≤2.5ULN), renal function was normal (1.5 times serum Cr≤1.5ULN), and no coagulation abnormalities were observed.
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- LVEF≥50% by echocardiography.
- Women of childbearing age must have a pregnancy test (serum or urine) with a negative result within 14 days before enrollment and be willing to use a reliable method of contraception during the trial.
- Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- Special types of DLBCL: DLBCL associated with chronic inflammation, lymphomatoid granuloma, primary mediastinal large B-cell lymphoma, B-cell lymphoma that cannot be classified (with intermediate features between DLBCL and classical Hodgkin's lymphoma), and primary central nervous system (CNS) DLBCL.
- Transformed DLBCL (such as follicular lymphoma, chronic lymphocytic leukemia/small B-cell lymphoma transformed DLBCL), secondary central nervous system invasion of DLBCL.
- A history of malignancies other than squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or carcinoma in situ of the cervix within the past 5 years.
- Major surgical procedures (excluding diagnostic procedures) performed within the past 2 months.
- Previous NHL treatment: including chemotherapy, immunotherapy, radiotherapy, monoclonal antibody therapy, surgical treatment (except diagnostic surgery and biopsy).
- Previous treatment with cytotoxic drugs or mab CD20 antibodies for other diseases (e.g., rheumatoid arthritis).
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- Those who used any monoclonal antibody within 3 months before enrollment, participated in other clinical trials and used other trial-related drugs, and were vaccinated with (attenuated) live virus vaccine within 1 month before enrollment.
- Had used hematopoietic cytokines within 2 weeks before enrollment.
- Patients with suspected active or latent tuberculosis.
- Personswith known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding fungal infections of the nail bed skin) or any major systemic infection event requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to enrollment (except neoplastic fever) .
- Hiv-positive persons. Active HBV-positive and HCV-positive individuals, but those whose disease was judged to be under control, should be enrolled with caution, but should undergo effective antiviral intervention.
- Other serious medical conditions that may limit the subject's participation in the study, such as uncontrolled diabetes; Severe cardiac insufficiency (NYHA grade II or above); Acute coronary syndrome in the last 6 months; Coronary revascularization such as stenting, cabG, and other cardiac and macrovascular procedures within the last 6 months; Severe arrhythmias include frequent ventricular premature, ventricular tachycardia, rapid atrial fibrillation/flutter, and severe bradycardia. （Uncontrolled hypertension: greater than 150/100mmHg). Gastric ulcers (those identified by the investigators as being at risk for perforation); Active autoimmune diseases; Severe hypertension; Patients with severe respiratory disease (e.g., obstructive pulmonary disease and history of bronchospasm), such as patients with a known history of interstitial pneumonia or a high suspicion of interstitial pneumonia; Or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- Contraindications for any of the study drugs, including previous anthracyclines; Patients with diabetes who could not tolerate prednisone in this protocol.
- Subject has a history of alcohol or drug abuse.
- Persons with allergies or known allergies to any pharmaceutical active ingredient, excipient, or murine product or xenogeneic protein included in this test.
- People with severe mental illness.
- Patients who were unable to comply during the trial and/or follow-up phase.
- Patients unable to swallow the study drug properly. Those who were deemed ineligible by the researchers.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Department of Medical Oncology,Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Li, Zhiming, M.D., Lizhm@sysucc.org.cn
Sun Peng, M.D., sunp@sysucc.org.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Li Zhiming, M.D., 020-87343292, Lizhm@sysucc.org.cn
Sun Peng, M.D., 020-87343292, sunp@sysucc.org.cn
About this study
Official title: A Single-arm、Multicenter、Open-label、Phase II Clinical Study of the Combination of Rituximab、Chidamide、Zanubrutinib-induced and CHOP Therapy for Untreated Dual-expressing Diffuse Large B Cell Lymphoma
This phase II trial studies how well giving rituximab,chidamide, and zanubrutinib with Sequential chemotherapy works in treating patients with double express diffuse large B-cell lymphoma. The prognosis of patients with DEL-DLBCL is usually worse than that of ordinary DLBCL.
- Being tested
- Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab, Chidamide, Zanubrutinib-induced and CHOP TherapyDrug
Also called RCZ WITH CHOP
All subjects received two courses of the following treatment:
Rituximab ，375mg/m²， D1； Chidamiade ，20mg ，biw， d1-14； Zanubrutinib ，160mg， bid， d1-21；
three weeks for a period of treatment, all subjects complete tumor assessment after two courses of treatment, patients which achieve complete remission continue for up to 8 sessions, patients achieve partial response and stable disease combined use of the following CHOP threapy to 6 courses, Patients with progressive disease dropped out of this research.
CHOP Therapy:
Cyclophosphamide， 750mg/m² ，D1； Vincristine， 1.4mg/m² ，D1 (maximum：2mg)； Doxorubicin or pirarubicin， 50mg/m²， D1； Prednisone ，30mg ，tid， D1-5.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (RCZ WITH CHOP) | Experimental | Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy Receives: Drug: Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
EOT-CRR
End of Treatment Complete Response Rate
Measured: 12 months
Secondary outcomes (4)
EOT-ORR
End of Treatment Overall Response Rate
Measured: 12 months
EOT-CRR2
End of Initial two courses of Treatment Complete Response Rate
Measured: 2 months
2year-PFS
2-year Progression Free Survival Rate
Measured: 24 months
2year-OS
2-year Overall Survival Rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start24 Feb 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double Express Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhiming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527912
- Sponsor's protocol ID
- B2022-588-01
- Status last verified
- Apr 2023
- First submitted
- 30 Aug 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm、Multicenter、Open-label、Phase II Clinical Study of the Combination of Rituximab、Chidamide、Zanubrutinib-induced and CHOP Therapy for Untreated Dual-expressing Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05527912
- Acronym / sponsor ID
- B2022-588-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Sep 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 phase II trial studies how well giving rituximab,chidamide, and zanubrutinib with Sequential chemotherapy works in treating patients with double express diffuse large B-cell lymphoma. The prognosis of patients with DEL-DLBCL is usually worse than that of ordinary DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I (RCZ WITH CHOP) | Experimental | Drug: Rituximab, Chidamide, Zanubrutinib-induced and CHOP TherapyRituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed dual-expression diffuse large B-cell lymphoma (DLBCL) with IHC BCL2 expression ≥50% and MYC expression ≥40%.
- Male or female patients: 18-65 years old.
- ECOG physical status score: 0~2 points.
- Estimated survival time ≥6 months.
- There must be at least 1 evaluable or measurable lesion that meets Lugano 2014 criteria [ evaluable lesion : 18F-fluorodeoxyglucose/Positron Emission Tomography (18FDG/PET) examination showed elevated lymph node or extranodal local uptake (higher than liver) and PET and/or Computed Tomography (CT) features consistent with lymphoma. Measurable lesion : Nodules >15mm or extranodal lesions >10mm with increased 18FDG uptake]. The absence of measurable lesions and increased diffuse hepatic uptake of 18FDG should be excluded.
Key exclusion criteria (18 listed)
- Special types of DLBCL: DLBCL associated with chronic inflammation, lymphomatoid granuloma, primary mediastinal large B-cell lymphoma, B-cell lymphoma that cannot be classified (with intermediate features between DLBCL and classical Hodgkin's lymphoma), and primary central nervous system (CNS) DLBCL.
- Transformed DLBCL (such as follicular lymphoma, chronic lymphocytic leukemia/small B-cell lymphoma transformed DLBCL), secondary central nervous system invasion of DLBCL.
- A history of malignancies other than squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or carcinoma in situ of the cervix within the past 5 years.
- Major surgical procedures (excluding diagnostic procedures) performed within the past 2 months.
- Previous NHL treatment: including chemotherapy, immunotherapy, radiotherapy, monoclonal antibody therapy, surgical treatment (except diagnostic surgery and biopsy).
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 |
|---|---|---|
| Rituximab, Chidamide, Zanubrutinib-induced and CHOP TherapyAlso: RCZ WITH CHOPAll subjects received two courses of the following treatment: Rituximab ，375mg/m²， D1； Chidamiade ，20mg ，biw， d1-14； Zanubrutinib ，160mg， bid， d1-21； three weeks for a period of treatment, all subjects complete tumor assessment after two courses of treatment, patients which achieve complete remission continue for up to 8 sessions, patients achieve partial response and stable disease combined use of the following CHOP threapy to 6 courses, Patients with progressive disease dropped out of this research. CHOP Therapy: Cyclophosphamide， 750mg/m² ，D1； Vincristine， 1.4mg/m² ，D1 (maximum：2mg)； Doxorubicin or pirarubicin， 50mg/m²， D1； Prednisone ，30mg ，tid， D1-5. | Drug | Arm I (RCZ WITH CHOP) |
Primary outcome
EOT-CRR
Time frame: 12 months
End of Treatment Complete Response Rate
4 secondary outcomes
EOT-ORR
Time frame: 12 months
EOT-CRR2
Time frame: 2 months
2year-PFS
Time frame: 24 months
2year-OS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Yes
Related trials for Double Express Diffuse Large B-cell Lymphoma
Not yet recruitingPhase 2
Zanubrutinib, Chidamide, and Rituximab Induction With or Without CHOP Versus R-CHOP in Newly Diagnosed Double-Expressor DLBCL
BTK Inhibitors, Histone Deacetylase Inhibitor
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy in people with Double Express Diffuse Large B-cell Lymphoma, run by Sun Yat-sen University at 2 sites 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 9 inclusion and 18 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Li, Zhiming, M.D. (02087343292, Lizhm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EOT-CRR (time frame: 12 months). 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 25 Apr 2023.