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

NCT05874778 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023NHLRT01
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Advanced Diffuse Large B-Cell Lymphoma; Extra-nodal Involvement, Large Mass; Radiotherapy

Keywords

Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 2-Year Event Free Survival Rate

  The proportion of enrolled patients who are free of events such as death, disease progression, switch to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, and other events

  2-Year

• 2-Year Progression-Free Survival Rate

  The percentage of people who did not have new tumor growth or cancer spread during or after treatment.

  2-Year

Secondary Outcomes (3)

• 2-Year Overall Survival

  2-Year

• Adverse Events related to Radiotherapy

  Adverse events that occur within 30 days

• 2-Year Local Control Rate

  2-Year

Study Arms (2)

Radiation Group

EXPERIMENTAL

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.

Drug: 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy; Radiation: Radiotherapy beyond standard R-CHOP Chemotherapy

Non-radiation Group

ACTIVE COMPARATOR

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.

Drug: 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy

Interventions

6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy DRUG

All enrolled patients will first complete a total of 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy (Rituximab + Cyclophosphamide + Doxorubicin + Prednisolone) and conduct evaluation about treatment effects (i.e. efficacy evaluation) once every 2 cycles, and after their completion of the 6th cycle, they will receive maintenance treatment . After the end of 6th cycle of treatment or after their leaving the group, efficacy evaluation is conducted every three months to obtain relevant data regarding the 2-year Progression-Free Survival(PFS) and survival of the subjects.

Non-radiation Group; Radiation Group

Radiotherapy beyond standard R-CHOP Chemotherapy RADIATION

Radiotherapy: after completion of the standard R-CHOP treatment, enrolled patients will be divided into radiotherapy group and non-radiotherapy group. In radiotherapy group, further consolidation radiotherapy targeting patients' pre-treatment large masses or extranodal affected areas will be given, with routine segmentation of 30-36Gy/15-18f.

Radiation Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age: no limit, male or female;
• ECOG score: 0-2
• The laboratory meets the following requirements:
• 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;
• Liver function: AST/ALT≤2×ULN, TBILI≤2×ULN;
• Renal Function : creatinine clearance rate(Ccr) ≥50ml/min
• 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;
• Expected survival period ≥ 6 months;
• The patient voluntarily joined the study and signed the informed consent;

You may not qualify if:

• Serum pregnancy test positive or breastfeeding women;
• Lymphoma patients with central nervous system (CNS) invasion;
• 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%;
• Patients with ≥2 grade neuropathy;
• Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired and congenital immunodeficiency diseases;
• Patients with severe active infection who require systemic antibiotic treatment;
• Have a history of serious neurological or psychiatric diseases, unable to participate in the trial normally, including dementia, epilepsy, severe depression and mania, etc.;
• 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;
• Patients considered by the investigator to be unsuitable for enrollment;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 25, 2023

Record last verified: 2023-04