Advanced Diffuse Large B-Cell LymphomaPhase 2NCT05874778
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 Phase 2 study testing 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy and Radiotherapy beyond standard R-CHOP Chemotherapy in people with Advanced Diffuse Large B-Cell Lymphoma and Extra-nodal Involvement, Large Mass, run by Tianjin Medical University Cancer Institute and Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Diffuse Large B-Cell Lymphoma, Extra-nodal Involvement, Large Mass, Radiotherapy
- What is being tested?
- 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy and Radiotherapy beyond standard R-CHOP Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 15 May 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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;
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- 4.3 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;
Who cannot join
- 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;
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- 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;
- -
About this study
Official title: 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
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.
Read the detailed description
Safety analysis:
The safety analysis is mainly based on descriptive statistical analysis, which lists and describes the incidence, severity, correlation, risk and outcome of adverse events (AE) in this trial.
Efficacy analysis:
The Kaplan-Meier method will be used to draw the overall survival curve and the progression-free survival curve, and to estimate the median survival time, median progression-free survival period and their 95% confidence intervals.
Before starting the study, patients must read and sign the current version of informed consent form approved by the Ethics Committee (EC). All research steps must be carried out within the time window specified in the research schedule.
The duration of safety data collection is from the patient signing the Informed Consent Form (ICF) to the end of the study, with all AEs recorded in the CRF.
The severity of AE will be evaluated based on the NCI CTCAE 5.0 standard. Each patient will undergo a series of planned visits and specific data will be recorded at different time points during the scheduled visits. All examinations/tests are recommended, and the exact examination/test items to be completed during the study shall be subject to clinical practice.
Investigators must be physicians who have been trained in terms of knowledge and conduct of clinical trials and work under the guidance of senior professionals; Prior to the start of the trial, the clinical ward must be inspected so as to ensure its compliance with standardized requirements and to ensure complete readiness of rescue equipment. It is recommended that professional nursing staff administer medication to the subjects and have a detailed understanding of the medication usage to ensure patient compliance; Each investigation site must strictly follow the study protocol; All participating sites should adhere to the ICH-GCP regulations and standard operating procedures (SOPs) for preservation, and all clinical trial information should be recorded, disposed of, and saved for purposes of accurate reporting, interpretation, and verification of study results; Confirm that all data records and reports are correct and complete, and save the original and essential documents related to the study.
This clinical study will be conducted in accordance with the principles established by the 18th World Federation of Medical Associations (Helsinki, 1964) and all subsequent revisions. Before enrollment, it is necessary to weigh the foreseeable risks and inconveniences that study may bring to the subjects against the potential benefits for enrolled patients. Clinical trials can only be initiated and continued when the expected benefits outweigh the risks. Prior to participating in clinical trials, each subject should provide voluntary informed consent, otherwise they cannot be screened or selected.
- Being tested
- 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy, Radiotherapy beyond standard R-CHOP Chemotherapy
- Keywords
- Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapyDrug
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.
Radiotherapy beyond standard R-CHOP ChemotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2-Year
Secondary outcomes (3)
2-Year Overall Survival
The percentage of enrolled patients who are alive 2 years after their enrollment .
Measured: 2-Year
Adverse Events related to Radiotherapy
The occurrence of Hematological and non-Hematological adverse event( NCI CTCAE v5.0）
Measured: Adverse events that occur within 30 days
2-Year Local Control Rate
The percentage of enrolled patients in radiotherapy group whose tumor volume is equal to or less than their tumor volume at start of radiotherapy
Measured: 2-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start15 May 2023 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874778
- Sponsor's protocol ID
- 2023NHLRT01
- Status last verified
- Apr 2023
- First submitted
- 16 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05874778
- Acronym / sponsor ID
- 2023NHLRT01
- Keywords
- Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 25 May 2023 (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 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.
Detailed description
Safety analysis:
The safety analysis is mainly based on descriptive statistical analysis, which lists and describes the incidence, severity, correlation, risk and outcome of adverse events (AE) in this trial.
Efficacy analysis:
The Kaplan-Meier method will be used to draw the overall survival curve and the progression-free survival curve, and to estimate the median survival time, median progression-free survival period and their 95% confidence intervals.
Before starting the study, patients must read and sign the current version of informed consent form approved by the Ethics Committee (EC). All research steps must be carried out within the time window specified in the research schedule.
The duration of safety data collection is from the patient signing the Informed Consent Form (ICF) to the end of the study, with all AEs recorded in the CRF.
The severity of AE will be evaluated based on the NCI CTCAE 5.0 standard. Each patient will undergo a series of planned visits and specific data will be recorded at different time points during the scheduled visits. All examinations/tests are recommended, and the exact examination/test items to be completed during the study shall be subject to clinical practice.
Investigators must be physicians who have been trained in terms of knowledge and conduct of clinical trials and work under the guidance of senior professionals; Prior to the start of the trial, the clinical ward must be inspected so as to ensure its compliance with standardized requirements and to ensure complete readiness of rescue equipment. It is recommended that professional nursing staff administer medication to the subjects and have a detailed understanding of the medication usage to ensure patient compliance; Each investigation site must strictly follow the study protocol; All participating sites should adhere to the ICH-GCP regulations and standard operating procedures (SOPs) for preservation, and all clinical trial information should be recorded, disposed of, and saved for purposes of accurate reporting, interpretation, and verification of study results; Confirm that all data records and reports are correct and complete, and save the original and essential documents related to the study.
This clinical study will be conducted in accordance with the principles established by the 18th World Federation of Medical Associations (Helsinki, 1964) and all subsequent revisions. Before enrollment, it is necessary to weigh the foreseeable risks and inconveniences that study may bring to the subjects against the potential benefits for enrolled patients. Clinical trials can only be initiated and continued when the expected benefits outweigh the risks. Prior to participating in clinical trials, each subject should provide voluntary informed consent, otherwise they cannot be screened or selected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation Group | Experimental | Drug: 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy, Radiation: Radiotherapy beyond standard R-CHOP ChemotherapyPaients 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. |
| Non-radiation Group | Active comparator | Drug: 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapyPaients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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;
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapyAll 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. | Drug | Non-radiation Group, Radiation Group |
| Radiotherapy beyond standard R-CHOP ChemotherapyRadiotherapy: 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 | Radiation Group |
Primary outcome
2-Year Event Free Survival Rate
Time frame: 2-Year
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 Progression-Free Survival Rate
Time frame: 2-Year
The percentage of people who did not have new tumor growth or cancer spread during or after treatment.
3 secondary outcomes
2-Year Overall Survival
Time frame: 2-Year
Adverse Events related to Radiotherapy
Time frame: Adverse events that occur within 30 days
2-Year Local Control Rate
Time frame: 2-Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy and Radiotherapy beyond standard R-CHOP Chemotherapy in people with Advanced Diffuse Large B-Cell Lymphoma and Extra-nodal Involvement, Large Mass, run by Tianjin Medical University Cancer Institute and 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 10 inclusion and 10 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 May 2023. 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.
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?
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?
2-Year Event Free Survival Rate (time frame: 2-Year). The study lists 2 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 25 May 2023.