Diffuse Large B Cell Lymphoma (DLBCL)DEL BiomarkerNCT06652152
Mechanism Investigation of R-CHOP Regimen or Tucidinostat Plus R-CHOP (CR-CHOP) Regimen in the Treatment of BCL2/MYC Protein Double Expressor Lymphoma
An observational study of Diffuse Large B Cell Lymphoma (DLBCL) and Double Expressor Lymphoma, run by Ruijin Hospital.
Trial summary
This study is trying to explore the mechanism of R-CHOP regimen or tucidinostat plus R-CHOP (CR-CHOP) regimen in the treatment of BCL2/MYC protein double expressor lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL), Double Expressor Lymphoma
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 30 Dec 2025
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with accessible tissue samples were selected from a phase III study of tucidinostat in combination with R-CHOP in patients with newly diagnosed double expressor DLBCL (NCT04231448).
Who may be able to join
- Each potential subject must satisfy all of the following criteria to be enrolled in the study.
- Male or female, age ≥ 18 years and ≤80 years. No prior treatment for diffuse large B cell lymphoma(DLBCL), including hemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy) Histological or cytological confirmation of DLBCL CD20-positive DLBCL; Myc≥40% as well as Bcl-2≥50% through immunohistochemistry; Not with double (BCL-2 and c-MYC gene rearrangement) or triple (BCL-2, BCL-6, and c-MYC gene rearrangement) hit by FISH.
- The verification of DLBCL will be based on local pathology report.15-20 unstained slides must be sent to the central laboratory for retrospective confirmation.
- 4.At least one positive lesion according to the Lugano Classification by fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography(CT).
- 5.Lymphoma International PrognosisIndex (IPI) score of 2,3,4. 6.Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2. 7.Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):
- (1)Hematology values:Hemoglobin (Hb)≥90g/L ; Absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN); Total bilirubin ≤1.5 × ULN; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT,AST≦5×ULN if liver involved).
- 8.Expected survival≥6 months. 9.All patients must have signed an informed consent document.
Who cannot join
- Any potential subject who meets any of the following criteria will be excluded from participating in the study.
- Presence of CNS involvement. Patients with primary DLBCL of the central nervous system (CNS),or secondary lymphoma of the central nervous system, or Primary mediastinal (thymic) large B-cell lymphoma, or Primary effusion lymphoma, or B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma, or Primary cutaneous DLBCL, leg type, or indolent lymphoma, or Burkitt lymphoma, or EBV-positive mucocutaneous ulcer, or DLBCL associated with chronic inflammation, or Lymphomatoid granulomatosis, or Intravascular large B-cell lymphoma, or ALK-positive large B-cell lymphoma, or Plasmablastic lymphoma, or HHV8-positive DLBCL, NOS, or primary testicular DLBCL.
- Patients with transformed lymphoma. History of organ transplantation or hematopoietic stem cell transplantation. Patients planned for autologous or allogeneic transplant as consolidation in first line.
- Patients with any other malignancy, except patients with a history of curatively treated basal or squamous cell carcinoma or in situ carcinoma of the cervix at any time prior to the study are eligible.
- Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody within 5 years of the start of Cycle 1.
- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1. Any investigational therapy within 3 months prior to the start of Cycle 1. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
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- Contraindication to any of the individual components of CHOP.
- Corticosteroid use > 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control:
- Patients receiving corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to randomization (Cycle 1, Day 1).
- If glucocorticoid treatment is urgently required for lymphoma symptom control prior to the start of study treatment, prednisone 100 mg or equivalent could be given for a maximum of 5 days, but all tumor assessments must be completed prior to start of glucocorticoid treatment.
- 13.Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy.
- 14.Have uncontrolled or significant cardiovascular disease, including: Grade II or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (New York Heart Association Functional Classification ) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) < 50% during screening stage.
- Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al).
- History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male), QTc≥470ms（female）at screening.
- Symptomatic coronary heart disease requiring treatment. Any other cardiovascular disease which is inappropriate for the study according to investigators' judgment.
- 15.History of interstitial lung disease(ILD), or with ongoing signs and symptoms by CT or MRI at the time of screening.
- 16.Patients with factors that could affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy.
- 17.History of deep vein thrombosis or pulmonary embolism. 18.History of active bleeding within 2 months prior to the start of Cycle 1;or patients receiving anticoagulation therapy; or patients with evidence of bleeding potential according to investigators' judgment ( esophageal varices, active ulcer, or fecal occult blood test positive etc. ). Patients with bleeding led by lymphoma according to investigators' judgment are eligible.
- 19.6 weeks or less from the last major surgery that involved crucial organs, or with any other factors impede postoperative recovery according to investigators' judgment.
- 20.Known active infection, or active and uncontrolled hepatitis B infection(HBV), hepatitis C Virus(HCV), human immunodeficiency virus (HIV)/AIDS (Acquired Immune Deficiency Syndrome), or any other serious infection. (active infection defined as any major episode of infection requiring systemic treatment; Patients with occult or prior HBV may be included if HBV DNA is undetectable.) 21.Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or limit compliance with study requirements/ treatment.
- 22.Drug or alcohol abuse. 23.Women of childbearing potential and men who are sexually active not willing to practice 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.These restrictions apply for 12 months after the last dose of rituximab or 12 weeks after the last dose of study drug, whichever is later. Pregnancy or lactation.
- 24.Any other condition which is inappropriate for the study according to investigators' judgment.
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: Mechanism Investigation of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) Regimen or Tucidinostat Plus R-CHOP (CR-CHOP) Regimen in the Treatment of BCL2/MYC Protein Double Expressor Lymphoma
This study is trying to explore the mechanism of R-CHOP regimen or tucidinostat plus R-CHOP (CR-CHOP) regimen in the treatment of BCL2/MYC protein double expressor lymphoma.
Read the detailed description
Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. This study is trying to explore the mechanism of R-CHOP regimen or tucidinostat plus R-CHOP (CR-CHOP) regimen in the treatment of BCL2/MYC protein double expressor lymphoma. We will retain the hematoxylin and eosin (HE) -stained slides of tumor tissue, immunohistochemical staining slides for BCL2 and MYC, as well as FFPE (Formalin Fixed Paraffin Embedded) tissues. We will conduct biological tests via digital pathology and DNA sequencing, aiming to uncover the pathogenic mechanism of double expressor lymphoma and the potential therapeutic targets of CR-CHOP regimen.
- Keywords
- diffuse large B cell lymphoma, double expressor lymphoma, BCL2, MYC, tucidinostat, biomarker
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival (EFS)
Defined as the duration from the date of randomization to the date of disease progression, relapse from CR , initiation of subsequent systemic antilymphoma therapy for residual disease, or death, whichever occurs first.
Measured: Up to approximately 5 years
Secondary outcomes (1)
Progression-Free Survival (PFS)
Defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first.
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Dec 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 (DLBCL)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 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
- NCT06652152
- Sponsor's protocol ID
- DEL Biomarker
- Acronym
- DEL Biomarker
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism Investigation of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) Regimen or Tucidinostat Plus R-CHOP (CR-CHOP) Regimen in the Treatment of BCL2/MYC Protein Double Expressor Lymphoma
- ClinicalTrials.gov ID
- NCT06652152
- Acronym / sponsor ID
- DEL Biomarker / DEL Biomarker
- Keywords
- diffuse large B cell lymphoma, double expressor lymphoma, BCL2, MYC, tucidinostat, biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Oct 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 study is trying to explore the mechanism of R-CHOP regimen or tucidinostat plus R-CHOP (CR-CHOP) regimen in the treatment of BCL2/MYC protein double expressor lymphoma.
Detailed description
Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. This study is trying to explore the mechanism of R-CHOP regimen or tucidinostat plus R-CHOP (CR-CHOP) regimen in the treatment of BCL2/MYC protein double expressor lymphoma. We will retain the hematoxylin and eosin (HE) -stained slides of tumor tissue, immunohistochemical staining slides for BCL2 and MYC, as well as FFPE (Formalin Fixed Paraffin Embedded) tissues. We will conduct biological tests via digital pathology and DNA sequencing, aiming to uncover the pathogenic mechanism of double expressor lymphoma and the potential therapeutic targets of CR-CHOP regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with accessible tissue samples were selected from a phase III study of tucidinostat in combination with R-CHOP in patients with newly diagnosed double expressor DLBCL (NCT04231448).
Key inclusion criteria (7 listed)
- Each potential subject must satisfy all of the following criteria to be enrolled in the study.
- Male or female, age ≥ 18 years and ≤80 years. No prior treatment for diffuse large B cell lymphoma(DLBCL), including hemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy) Histological or cytological confirmation of DLBCL CD20-positive DLBCL; Myc≥40% as well as Bcl-2≥50% through immunohistochemistry; Not with double (BCL-2 and c-MYC gene rearrangement) or triple (BCL-2, BCL-6, and c-MYC gene rearrangement) hit by FISH.
- The verification of DLBCL will be based on local pathology report.15-20 unstained slides must be sent to the central laboratory for retrospective confirmation.
- 4.At least one positive lesion according to the Lugano Classification by fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography(CT).
- 5.Lymphoma International PrognosisIndex (IPI) score of 2,3,4. 6.Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2. 7.Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):
Key exclusion criteria (22 listed)
- Any potential subject who meets any of the following criteria will be excluded from participating in the study.
- Presence of CNS involvement. Patients with primary DLBCL of the central nervous system (CNS),or secondary lymphoma of the central nervous system, or Primary mediastinal (thymic) large B-cell lymphoma, or Primary effusion lymphoma, or B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma, or Primary cutaneous DLBCL, leg type, or indolent lymphoma, or Burkitt lymphoma, or EBV-positive mucocutaneous ulcer, or DLBCL associated with chronic inflammation, or Lymphomatoid granulomatosis, or Intravascular large B-cell lymphoma, or ALK-positive large B-cell lymphoma, or Plasmablastic lymphoma, or HHV8-positive DLBCL, NOS, or primary testicular DLBCL.
- Patients with transformed lymphoma. History of organ transplantation or hematopoietic stem cell transplantation. Patients planned for autologous or allogeneic transplant as consolidation in first line.
- Patients with any other malignancy, except patients with a history of curatively treated basal or squamous cell carcinoma or in situ carcinoma of the cervix at any time prior to the study are eligible.
- Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody within 5 years of the start of Cycle 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Event Free Survival (EFS)
Time frame: Up to approximately 5 years
Defined as the duration from the date of randomization to the date of disease progression, relapse from CR , initiation of subsequent systemic antilymphoma therapy for residual disease, or death, whichever occurs first.
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: Up to approximately 5 years
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 22 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Diffuse Large B Cell Lymphoma (DLBCL) and Double Expressor 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 7 inclusion and 22 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 22 Oct 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.
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 (+862164370045 ext. 610707, zwl_trial@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 approximately 5 years). 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 22 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.