Clinical trial · Interventional
A Multicenter, Phase 2 Study Evaluating the Value of Radiotherapy in Advanced Diffuse Large B-cell Lymphoma Patients With Extranodal Involvement and Large Tumors Undergoing Immunochemotherapy for PET-CT Assessment of Complete Remission
A Multicenter, Phase 2 Study Evaluating the Value of Radiotherapy in Advanced Diffuse Large B-cell Lymphoma Patients With Extranodal Involvement and Large Tumors Who Had Complete Remission as Assessed by PET-CT After Immune-chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, single center, phase II clinical study involving 108 patients with primary and late stage Diffuse Large B-cell Lymphoma complicated by large masses and extranodal involvement. The study aims to evaluate the efficacy of radiotherapy targeting large masses and extranodal involvement in treatment-naïve advanced DLBCL patients with large mass lesions and/or extranodal involvement after they had initially been treated with standard immunochemotherapy and received complete remission as assessed by PET-CT. After completing the standard immunochemotherapy, subjects will be randomly divided into the radiotherapy group or the non-radiotherapy group, and the curative effects will be evaluated every three months after the end of the treatment or after their leaving the group, so as to obtain the relevant data and data of the 2-year Progression Free Survival, survival of the subjects and Treatment-related side effects.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Extra-nodal Involvement, Large Mass | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy | Drug | — | UNRESOLVED |
| Radiotherapy beyond standard R-CHOP Chemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiation Group
- description
- Paients will be treated with 6-8 cycles (21 days per cycle) of standard R-CHOP chemotherapy. After completing the standard immunochemotherapy, subjects will be randomly divided into the radiotherapy group or the non-radiotherapy group, and the curative effects will be evaluated every three months after the end of the treatment or after a patient's leaving the group, so as to obtain the relevant data including those for figuring up 2-year PFS and survival of subjects and any treatment-related side effects as well.
- interventionNames
- Drug: 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy
- Radiation: Radiotherapy beyond standard R-CHOP Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Non-radiation Group
- description
- Paients will be treated with 6-8 cycles (21 days per cycle) of standard R-CHOP chemotherapy, but after this treatment patients will not be further given radiation therapy.
- interventionNames
- Drug: 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Using the World Health Organization (WHO) classification of diseases, newly diagnosed diffuse large B-cell lymphoma with large masses (tumor diameter ≥ 7.5cm) and or extranodal involvement patients diagnosed by histology 2. Age: no limit, male or female; 3. ECOG score: 0-2 4. The laboratory meets the following requirements: 4.1 The bone marrow hematopoietic function is basically normal: WBC ≥ 3.5×10\^9/L, ANC ≥ 1.0×10\^9/L, PLT ≥ 75 ×10\^9/L, Hb ≥ 80g/L; 4.2 Liver function: AST/ALT≤2×ULN, TBILI≤2×ULN; 4.3 Renal Function : creatinine clearance rate(Ccr) ≥50ml/min 5. Non-menopausal or non-surgical sterilization female patients of childbearing age must have a serum pregnancy test within 3 days before the first medication, and the result is negative; and they must be non-lactating. Female patients of childbearing age or male patients whose partners are women of childbearing age must agree to use highly effective methods of contraception during the study and within 6 months after the last administration of the study drug; 6. Expected survival period ≥ 6 months; 7. The patient voluntarily joined the study and signed the informed consent; Exclusion Criteria: 1. Serum pregnancy test positive or breastfeeding women; 2. Lymphoma patients with central nervous system (CNS) invasion; 3. Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before randomization, congestive heart failure (NYHA), cardiac function class III or IV; or cardiac left ventricular ejection fraction \<50%; 4. Patients with ≥2 grade neuropathy; 5. Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired and congenital immunodeficiency diseases; 6. Patients with severe active infection who require systemic antibiotic treatment; 7. Have a history of serious neurological or psychiatric diseases, unable to participate in the trial normally, including dementia, epilepsy, severe depression and mania, etc.; 8. Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the research or the evaluation of the research results; 9. Patients considered by the investigator to be unsuitable for enrollment; \-
References
Publications (0)
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