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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
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.
Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.
Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGComplete Response Rate (CRR)
To assess the Complete Response Rate (CR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin).
Time frame: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days
Overall Response Rate (ORR)
To assess the Overall Response Rate (ORR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin).
Time frame: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days
Progression-free survival (PFS)
The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first."
Time frame: up to 2 years
Event free survival(EFS)
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.
Time frame: up to 2 years
Overall Survival(OS)
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.
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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.
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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.
Time frame: up to 2 years
Quality of Life Assessment - EORTC QLQ-C30 Score
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.
Time frame: up to 2 years
Quality of Life Assessment - FACT-Lym Score
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.
Time frame: up to 2 years