Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions
Keywords
Diffuse Large B-Cell Lymphoma
Brief summary
A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma
Detailed description
This is a single-arm, open-label, multicenter Phase II trial to evaluate the feasibility, efficacy, and safety of the CRP regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in treating elderly patients with previously untreated double-expressor diffuse large B-cell lymphoma.
Interventions
DRUGChidamide
Chidamide: patients followed a step-dose escalation regimen (10mg BIW,15mg BIW, 20mg BIW). 21 days as a treatment cycle. The maximum number of treatment cycles is six.
DRUGRituximab
Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.
DRUGPolatuzumab Vedotin
Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.
DRUGChidamide Maintenance
For patients assessed as being in PR or CR status after completion of combination therapy, maintenance therapy with chidamide is administered for one year at a dosage of 20 mg, BIW. Drug adjustments may be made based on the patient's tolerance, with reference to the drug prescribing information.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥70 years, or patients aged 60-69 years with an ECOG performance status score of 2-4. Both males and females are eligible. 2. No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at the lymphoma (excluding palliative radiotherapy for symptom relief), or surgical therapy (excluding diagnostic biopsy or surgery not targeting the lymphoma). 3. Histopathological confirmation meeting all of the following conditions: 1. Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype). 2. At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma. 4. Laboratory tests at screening must meet the following criteria, unless the investigator attributes abnormalities to lymphoma (no corrective or supportive therapy for these parameters within 2 weeks prior to assessment): 1. Hematology: Hb ≥90 g/L, ANC ≥1.5 × 10⁹/L, PLT ≥90 × 10⁹/L. 2. Biochemistry: Cr ≤1.5 ×ULN; TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (for patients with liver involvement: ≤5 × ULN). 5. Life expectancy of at least 6 months, as judged by the investigator. 6. Ability to understand and voluntarily provide written informed consent.
Exclusion criteria
1. History of or concurrent other active malignancies. 2. Prior treatment with Chidamide and/or R-CHOP. Contraindication to any component of CHOP, including prior anthracycline therapy. History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies, or known sensitivity/allergy to murine products. 3. Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma); Primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; Central nervous system (CNS) lymphoma (primary or secondary); Primary effusion DLBCL; Primary cutaneous DLBCL, leg type. 4. History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed consent; or prior coronary angioplasty/stenting within 12 months. 5. Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage. 6. Pregnant or lactating women. 7. Participation in any other clinical trial within 6 months prior to signing informed consent. 8. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CRR) | up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days | To assess the Complete Response Rate (CR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days | To assess the Overall Response Rate (ORR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin). |
| Progression-free survival (PFS) | up to 2 years | The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first." |
| Event free survival(EFS) | up to 2 years | The duration from the time of study enrollment until the occurrence of disease progression, relapse after complete response (CR), death from any cause, or the initiation of new treatment for residual lesions after completion of combination therapy (including switched therapy for lesions during the trial), whichever occurs first. |
| Overall Survival(OS) | up to 2 years | The time from subject enrollment to Death caused by any reason. for patients lost to follow-up, the time of the last follow-up; for patients still alive at the end of study, the date of the end of follow-up. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 2 years | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.The frequency and severity of adverse events were evaluated based on changes in various vital sign indicators and laboratory tests. |
| Quality of Life Assessment - EORTC QLQ-C30 Score | up to 2 years | Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The score changes in overall quality of life, functional scales, and symptom scales will be analyzed in relation to clinical outcomes. |
| Quality of Life Assessment - FACT-Lym Score | up to 2 years | Disease-specific quality of life will be assessed using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire (Version 4). The score changes will be analyzed in relation to clinical outcomes. |
Countries
China
Contacts
CONTACTHuilai Zhang
STUDY_DIRECTORHuilai Zhang
Tianjin Medical University Cancer Insititute & Hospital
Outcome results
None listed