Newly Diagnosed MYC/BCL2 Double-expressor DLBCLPhase 2SCREENNCT07538180
Serplulimab, Chidamide, and Rituximab Followed by Sequential R-CHOP for Newly Diagnosed Elderly MYC/BCL2 Double-Expressor DLBCL
A Phase 2 study testing SCR Regimen Sequential with R-CHOP and Maintenance Therapy in people with Newly Diagnosed MYC/BCL2 Double-expressor DLBCL, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is a phase II clinical trial and is divided into three stages. Stage 1: Chemotherapy-free phase. All subjects will receive "Serplulimab, Chidamide, and Rituximab (SCR) therapy". After 2 treatment cycles, efficacy will be evaluated. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Newly Diagnosed MYC/BCL2 Double-expressor DLBCL
- What is being tested?
- SCR Regimen Sequential with R-CHOP and Maintenance Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 31 Dec 2028
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the Informed Consent Form (ICF); willing and able to comply with and complete all trial procedures.
- Age ≥ 60 years and ≤ 80 years at the time of signing the ICF.
- Treatment-naïve, having received no prior anti-lymphoma therapy.
- Confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) by central histopathology, meeting the following criteria:
- Concurrent positive expression of MYC and BCL2 proteins (IHC WHO standards: MYC ≥40%, BCL2 ≥50%).
- Not a "double-hit" or "triple-hit" lymphoma: FISH testing must not show the presence of "MYC and BCL2 rearrangements" or "MYC and BCL6 rearrangements" or "MYC and BCL2 and BCL6 rearrangements".
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- Lugano clinical stage II-IV, or stage I with bulky disease (mass diameter >7.5 cm).
- International Prognostic Index (IPI) score of 2-5.
- Availability of archival or freshly obtained tumor tissue samples from core needle biopsy or excision (10-15 unstained, freshly frozen, formalin-fixed paraffin-embedded [FFPE] slides).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy greater than 12 months.
- Must have at least one evaluable or measurable lesion according to the LYRIC 2016 criteria.Evaluable lesion: 18FDG/PET scan showing focally increased nodal or extranodal uptake (higher than liver) with PET and/or CT features consistent with lymphoma. Measurable lesion: Nodal lesion with long axis >15 mm or extranodal lesion with long axis >10 mm (if the only measurable lesion was previously irradiated, there must be evidence of post-radiation progression), accompanied by increased 18FDG uptake.Cases with no measurable lesions and diffuse hepatic 18FDG uptake higher than liver are excluded.
- Adequate organ and bone marrow function, without severe hematological abnormalities or significant cardiac, pulmonary, hepatic, renal, thyroid dysfunction, or immunodeficiency (without transfusion, granulocyte colony-stimulating factor, or other relevant medical support within 14 days prior to study drug administration):
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (≥1.0 × 10⁹/L for patients with bone marrow involvement).
- Platelets ≥75 × 10⁹/L (≥50 × 10⁹/L for patients with bone marrow involvement).
- Hemoglobin ≥9 g/dL.
- Serum creatinine ≤1.5 × Upper Limit of Normal (ULN), OR creatinine clearance ≥40 mL/min (calculated using the Cockcroft-Gault formula).
- Serum total bilirubin ≤1.5 × ULN.
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5 × ULN or ≤5 × ULN (in cases of hepatic involvement by lymphoma).
- Coagulation: International Normalized Ratio (INR) ≤1.5 × ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN (unless the subject is receiving anticoagulant therapy and PT/APTT at screening is within the therapeutic range for the intended use of anticoagulants).
- Thyroid-Stimulating Hormone (TSH), Free Thyroxine (FT4), or Free Triiodothyronine (FT3) within normal range ±10%.
- No evidence of dyspnea at rest, and a resting pulse oximetry reading >92%.
Who cannot join
- Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
- Primary mediastinal (thymic) large B-cell lymphoma, primary effusion DLBCL, unclassifiable B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma), primary cutaneous DLBCL, leg type, intravascular large B-cell lymphoma, ALK-positive large B-cell lymphoma, plasmablastic lymphoma, HHV8-positive DLBCL.
- Transformed lymphoma, i.e., transformed from other types of lymphoma such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma.
- History of severe hypersensitivity or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Presence of an active autoimmune disease that has required systemic treatment within the past two years. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Patients with autoimmune diseases that did not require systemic treatment in the past two years may be enrolled.
- Systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to the start of study treatment. The use of topical, ocular, intra-articular, intranasal, or inhaled corticosteroids (with minimal systemic absorption) is permitted. Short-term (≤7 days) prophylactic use of corticosteroids (e.g., for contrast allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted. An exception may be made for patients requiring corticosteroids for symptom control due to high tumor burden (prednisone up to 100mg/day or equivalent, for a maximum of 7 days is permitted).
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- Diagnosis of another malignancy within the past 5 years, except for malignancies treated with curative intent, including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast, or carcinoma in situ of the cervix.
- Prior systemic anti-tumor therapy within 28 days before the start of study treatment, including chemotherapy, immunotherapy, or biologic therapy (e.g., cancer vaccines, cytokines, or growth factors targeting cancer control).
- Major surgery within 28 days prior to the start of study treatment, or radiotherapy within 90 days prior.
- Treatment with Chinese herbal medicines or proprietary Chinese medicines with anti-cancer indications within 7 days prior to the start of study treatment.
- Administration of a live vaccine within 28 days prior to the start of study treatment, with the exception of inactivated influenza vaccines.
- Known history of infection with Human Immunodeficiency Virus (HIV) and/or Acquired Immunodeficiency Syndrome (AIDS).
- Patients with active chronic hepatitis B or active hepatitis C.
- Patients who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody during screening are eligible only if subsequent testing confirms: HBV DNA titer ≤ 2500 copies/mL or 1000 IU/mL, AND/OR HCV RNA below the lower limit of detection of the assay.
- This is to exclude patients with active hepatitis B or C infection requiring therapy. Asymptomatic carriers with controlled HBV (DNA titer as above) or cured hepatitis C are eligible.
- Any active infection requiring systemic anti-infective therapy within 14 days prior to the start of study treatment.
- Uncontrolled concurrent illness, including but not limited to: symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer disease, or bleeding disorders.
- History of interstitial lung disease or non-infectious pneumonitis. Patients with a history of drug-induced or radiation-induced non-infectious pneumonitis that is asymptomatic may be enrolled.
- QTcF interval > 450 msec, unless secondary to bundle branch block.
- Any underlying medical condition that, in the investigator's judgment, would substantially increase the risk associated with the patient's participation in the study, or confound the interpretation of toxicities.
- Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Serplulimab, Chidamide, and Rituximab Followed by R-CHOP in Newly Diagnosed Elderly Patients With MYC/BCL2 Double-Expressor Diffuse Large B-Cell Lymphoma
This study is a phase II clinical trial and is divided into three stages.
Stage 1: Chemotherapy-free phase. All subjects will receive "Serplulimab, Chidamide, and Rituximab (SCR) therapy". After 2 treatment cycles, efficacy will be evaluated. Subjects who achieve CR or CMR will continue to receive 2 additional cycles of SCR therapy. Patients who do not achieve CR or CMR will proceed to Stage 2 treatment. The SCR regimen consists of rituximab 375mg/m² IV on day 1, serplulimab 300mg IV on day 2, and chidamide 30mg PO twice weekly (on days 1, 4, 8, 11, 14, and 18), repeated every 21 days.
Read more
Stage 2: Chemotherapy Phase. Subjects who achieved CR or CMR in Stage 1 will receive 4 cycles of R-CHOP therapy, while those who did not achieve CR or CMR will receive 6 cycles of R-CHOP therapy. Patients at high risk for central nervous system (CNS) involvement will receive consensus-recommended CNS prophylactic therapy (e.g., high-dose methotrexate). The R-CHOP regimen is administered at the following dosages: rituximab 375mg/m², cyclophosphamide 750mg/m², doxorubicin 50mg/m², all administered intravenously on day 1; vincristine 1.4mg/m² (max 2mg) intravenously on day 1; and prednisone 100mg orally on days 1-5. The treatment cycle is repeated every 21 days. For patients over 75 years of age or those considered frail, the R-miniCHOP regimen may be utilized.
Stage 3: Maintenance Therapy. Subjects who achieve CR/CMR or PR/PMR in Stage 2 will proceed to the maintenance phase, receiving serplulimab in combination with chidamide for 6 months. Subjects who do not achieve CR/CMR or PR/PMR in Stage 2 will be withdrawn from the study. During the maintenance phase, the regimen consists of serplulimab 300mg administered intravenously on day 1 and chidamide 30mg administered orally twice per week (specifically on days 1, 4, 8, 11, 14, and 18) of a 30-day cycle.
- Being tested
- SCR Regimen Sequential with R-CHOP and Maintenance Therapy
- Keywords
- newly diagnosed MYC/BCL2 double-expressor DLBCL, SCR Regimen, SCREEN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCR Regimen Sequential with R-CHOP and Maintenance TherapyDrug
Induction Phase (Chemotherapy-free): Serplulimab 300mg IV day 2 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) + Rituximab 375mg/m² IV day 1 per 21-day cycle for 2 cycles
Consolidation Phase (Chemotherapy): R-CHOP regimen (Rituximab 375mg/m² + Cyclophosphamide 750mg/m² + Doxorubicin 50mg/m² + Vincristine 1.4mg/m² [max 2mg] IV day 1 + Prednisone 100mg PO days 1-5) per 21-day cycle for 4-6 cycles based on interim response
Maintenance Phase: Serplulimab 300mg IV day 1 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) per 30-day cycle for 6 months
| Study group | Role | What they receive |
|---|---|---|
| SCR Regimen Sequential with R-CHOP and Maintenance Therapy | Experimental | Induction Phase (Chemotherapy-free): Serplulimab 300mg IV day 2 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) + Rituximab 375mg/m² IV day 1 per 21-day cycle for 2 cycles
Consolidation Phase (Chemotherapy): R-CHOP regimen (Rituximab 375mg/m² + Cyclophosphamide 750mg/m² + Doxorubicin 50mg/m² + Vincristine 1.4mg/m² [max 2mg] IV day 1 + Prednisone 100mg PO days 1-5) per 21-day cycle for 4-6 cycles based on interim response
Maintenance Phase: Serplulimab 300mg IV day 1 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) per 30-day cycle for 6 months Receives: Drug: SCR Regimen Sequential with R-CHOP and Maintenance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate (ORR) as Assessed per the LYRIC (Lugano Classification Modified for Response Evaluation in Lymphoma) 2016 Criteria.
Measured: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)
Complete Remission rate
Complete Remission rate as Assessed per the LYRIC (Lugano Classification Modified for Response Evaluation in Lymphoma) 2016 Criteria.
Measured: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)
Partial Remission Rate
Partial Remission Rate as Assessed per the LYRIC (Lugano Classification Modified for Response Evaluation in Lymphoma) 2016 Criteria.
Measured: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)
Secondary outcomes (5)
Progression Free Survival
Progression-Free Survival (PFS) is defined as the time (in months) from the first dose of the study drug until the first documented disease progression or death from any cause (whichever occurs first).
Measured: From start of treatment until disease progression or end of study, whichever occurs first, up to 3 years)
Duration of Response
Duration of Response (DoR) is defined as the time from the initial documented response (CR or PR, whichever is recorded first) until the first documented disease progression or death from any cause.
Measured: From the initial documented response(CR or PR, whichever is recorded first) until disease progression or end of study, whichever occurs first, up to 3 years)
Even free survival
Event-free Survival (EFS) is defined as the time from randomization/enrollment until the occurrence of any event, including death, disease progression, change in treatment regimen due to inadequate response or toxicity, or the onset of fatal or intolerab
Measured: From start of treatment until death, disease progression, change in treatment regimen or end of study, whichever occurs first, up to 3 years
Overall survival
Overall Survival (OS) is defined as the time from the first dose of the study drug until death from any cause.
Measured: From start of treatment until death or end of study, whichever occurs first, up to 3 years
Adverse Event
Frequency and severity of adverse events (AEs).
Measured: From start of treatment until disease progression or end of study, whichever occurs first, up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start30 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed MYC/BCL2 Double-expressor DLBCLStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538180
- Sponsor's protocol ID
- SCREEN
- Acronym
- SCREEN
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2025
- Last updated
- 20 Apr 2026
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Serplulimab, Chidamide, and Rituximab Followed by R-CHOP in Newly Diagnosed Elderly Patients With MYC/BCL2 Double-Expressor Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07538180
- Acronym / sponsor ID
- SCREEN / SCREEN
- Keywords
- newly diagnosed MYC/BCL2 double-expressor DLBCL, SCR Regimen, SCREEN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Apr 2026 (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 a phase II clinical trial and is divided into three stages.
Stage 1: Chemotherapy-free phase. All subjects will receive "Serplulimab, Chidamide, and Rituximab (SCR) therapy". After 2 treatment cycles, efficacy will be evaluated. Subjects who achieve CR or CMR will continue to receive 2 additional cycles of SCR therapy. Patients who do not achieve CR or CMR will proceed to Stage 2 treatment. The SCR regimen consists of rituximab 375mg/m² IV on day 1, serplulimab 300mg IV on day 2, and chidamide 30mg PO twice weekly (on days 1, 4, 8, 11, 14, and 18), repeated every 21 days.
Stage 2: Chemotherapy Phase. Subjects who achieved CR or CMR in Stage 1 will receive 4 cycles of R-CHOP therapy, while those who did not achieve CR or CMR will receive 6 cycles of R-CHOP therapy. Patients at high risk for central nervous system (CNS) involvement will receive consensus-recommended CNS prophylactic therapy (e.g., high-dose methotrexate). The R-CHOP regimen is administered at the following dosages: rituximab 375mg/m², cyclophosphamide 750mg/m², doxorubicin 50mg/m², all administered intravenously on day 1; vincristine 1.4mg/m² (max 2mg) intravenously on day 1; and prednisone 100mg orally on days 1-5. The treatment cycle is repeated every 21 days. For patients over 75 years of age or those considered frail, the R-miniCHOP regimen may be utilized.
Stage 3: Maintenance Therapy. Subjects who achieve CR/CMR or PR/PMR in Stage 2 will proceed to the maintenance phase, receiving serplulimab in combination with chidamide for 6 months. Subjects who do not achieve CR/CMR or PR/PMR in Stage 2 will be withdrawn from the study. During the maintenance phase, the regimen consists of serplulimab 300mg administered intravenously on day 1 and chidamide 30mg administered orally twice per week (specifically on days 1, 4, 8, 11, 14, and 18) of a 30-day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCR Regimen Sequential with R-CHOP and Maintenance Therapy | Experimental | Drug: SCR Regimen Sequential with R-CHOP and Maintenance TherapyInduction Phase (Chemotherapy-free): Serplulimab 300mg IV day 2 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) + Rituximab 375mg/m² IV day 1 per 21-day cycle for 2 cycles Consolidation Phase (Chemotherapy): R-CHOP regimen (Rituximab 375mg/m² + Cyclophosphamide 750mg/m² + Doxorubicin 50mg/m² + Vincristine 1.4mg/m² [max 2mg] IV day 1 + Prednisone 100mg PO days 1-5) per 21-day cycle for 4-6 cycles based on interim response Maintenance Phase: Serplulimab 300mg IV day 1 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) per 30-day cycle for 6 months |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the Informed Consent Form (ICF); willing and able to comply with and complete all trial procedures.
- Age ≥ 60 years and ≤ 80 years at the time of signing the ICF.
- Treatment-naïve, having received no prior anti-lymphoma therapy.
- Confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) by central histopathology, meeting the following criteria:
- Concurrent positive expression of MYC and BCL2 proteins (IHC WHO standards: MYC ≥40%, BCL2 ≥50%).
Key exclusion criteria (21 listed)
- Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
- Primary mediastinal (thymic) large B-cell lymphoma, primary effusion DLBCL, unclassifiable B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma), primary cutaneous DLBCL, leg type, intravascular large B-cell lymphoma, ALK-positive large B-cell lymphoma, plasmablastic lymphoma, HHV8-positive DLBCL.
- Transformed lymphoma, i.e., transformed from other types of lymphoma such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma.
- History of severe hypersensitivity or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Presence of an active autoimmune disease that has required systemic treatment within the past two years. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Patients with autoimmune diseases that did not require systemic treatment in the past two years may be enrolled.
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 |
|---|---|---|
| SCR Regimen Sequential with R-CHOP and Maintenance TherapyInduction Phase (Chemotherapy-free): Serplulimab 300mg IV day 2 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) + Rituximab 375mg/m² IV day 1 per 21-day cycle for 2 cycles Consolidation Phase (Chemotherapy): R-CHOP regimen (Rituximab 375mg/m² + Cyclophosphamide 750mg/m² + Doxorubicin 50mg/m² + Vincristine 1.4mg/m² [max 2mg] IV day 1 + Prednisone 100mg PO days 1-5) per 21-day cycle for 4-6 cycles based on interim response Maintenance Phase: Serplulimab 300mg IV day 1 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) per 30-day cycle for 6 months | Drug | SCR Regimen Sequential with R-CHOP and Maintenance Therapy |
Primary outcome
Objective Response Rate
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)
Objective Response Rate (ORR) as Assessed per the LYRIC (Lugano Classification Modified for Response Evaluation in Lymphoma) 2016 Criteria.
Complete Remission rate
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)
Complete Remission rate as Assessed per the LYRIC (Lugano Classification Modified for Response Evaluation in Lymphoma) 2016 Criteria.
Partial Remission Rate
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)
Partial Remission Rate as Assessed per the LYRIC (Lugano Classification Modified for Response Evaluation in Lymphoma) 2016 Criteria.
5 secondary outcomes
Progression Free Survival
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, up to 3 years)
Duration of Response
Time frame: From the initial documented response(CR or PR, whichever is recorded first) until disease progression or end of study, whichever occurs first, up to 3 years)
Even free survival
Time frame: From start of treatment until death, disease progression, change in treatment regimen or end of study, whichever occurs first, up to 3 years
Overall survival
Time frame: From start of treatment until death or end of study, whichever occurs first, up to 3 years
Adverse Event
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, up to 3 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 20 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 SCR Regimen Sequential with R-CHOP and Maintenance Therapy in people with Newly Diagnosed MYC/BCL2 Double-expressor DLBCL, run by Sun Yat-sen 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 22 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)). The study lists 3 primary outcomes in all. 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 20 Apr 2026.