CTRI/2025/04/085952招募中4 期
A Phase IV, Open Label, Study Evaluating the safety and efficacy of Polatuzumab Vedotin in combination with Rituximab and CHP (R-CHP) in previously untreated adult patients with diffuse large B-cell Lymphoma (DLBCL)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- -Incidence of any adverse events
研究概览
简要总结
This is a Phase IV, open-label, multicenter, trial evaluating the safety and efficacy of polatuzumab vedotin in combination with R-CHP in adult patients with previously untreated CD20-positive DLBCL with International Prognostic Index (IPI) 2-5. This trial will serve as the main evidence for determining the benefit-risk of polatuzumab vedotin plus R-CHP in the target population. Primary Objective is to evaluate the safety of polatuzumab vedotin plus R-CHP. Secondary objective is To evaluate the efficacy of polatuzumab vedotin plus rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed written Informed Consent Form
- •IPI score of 2 to 5
- •Previously untreated patients with CD20 positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms a.
- •DLBCL, not otherwise specified including germinal center B-cell type, activated B-cell type b.
- •DLBCL with MYC and BCL2 rearrangements
- •ECOG Performance Status of 0, 1, or 2
- •At least one bidimensionally measurable lesion, defined as more than 1.5 cm in its longest dimension as measured by CT or MRI
- •Left ventricular ejection fraction (LVEF) more than equal to 50percent on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- •Adequate hematologic function a.
- •Hemoglobin more than equal to 9.0 g/dL without packed RBC transfusion during 14 days before first treatment b.
- •Platelet count more than equal to 75,000 per microL
- •For men and women of childbearing potential should be in agreement to remain abstinent.
排除标准
- •Contraindication to any of the individual components of RCHP, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products.
- •Prior organ transplantation
- •Current Grade more than 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
- •History of indolent lymphoma
- •Other histologies than those described in the inclusion criteria
- •Current diagnosis of the following: follicular lymphoma Grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma ; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; CNS lymphoma , primary effusion DLBCL, and primary cutaneous DLBCL.
- •Prior treatment with cytotoxic drugs within 5 years of screening for any condition (e.g., cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody
- •Prior use of any monoclonal antibody within 3 months of the start of Cycle 1; any investigational therapy within 28 days prior to the start of Cycle 1; vaccination with live vaccines within 28 days prior the start of Cycle 1
- •Prior radiotherapy to the mediastinal/pericardial region
- •Prior therapy for DLBCL.
- •Corticosteroids are addressed in the next point
- •Corticosteroid use more than 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control: -Patients receiving corticosteroid treatment with less than equal to 30 mg/day of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of Cycle
- •Patients who require lymphoma symptom control during screening may receive steroids in the following manner: Up to 30 mg/day of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of more than 30 to 100 mg/day of prednisone or equivalent.
- •Prednisone more than 30 to 100 mg/day or equivalent may be given for a maximum of 7 days as a pre-phase treatment
- •History of other malignancy that could affect compliance with the protocol or interpretation of results
- •Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
- •Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
- •History or presence of an abnormal ECG that is clinically significant in the investigators opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction.
- •Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle
- •Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
- •Illicit drug or alcohol abuse within 12 months prior to screening, in the investigators judgment
- •Any of the following abnormal laboratory values: a.
- •INR or PT more than 1.5x upper limit of normal (ULN) in the absence of therapeutic anticoagulation b.
- •PTT or aPTT more than 1.5 ULN in the absence of a lupus anticoagulant c.
- •Serum AST and ALT more than equal to 2.5 ULN d.
- •Total bilirubin more than equal to 1.5 ULN Patients with documented Gilbert disease may be enrolled if total bilirubin is less than equal to 3.0 ULN.
- •Serum creatinine clearance less than 40 mL/min
- •Patients with suspected active or latent tuberculosis, Positive test results for chronic hepatitis B infection, Positive test results for hepatitis C, Known history of HIV seropositive status, Patients with a history of progressive multifocal leukoencephalopathy, Pregnancy or lactation or intending to become pregnant during study.
结局指标
主要结局
-Incidence of any adverse events
时间窗: -Outcome will be assess at every patient visits Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, and study completion visit
-Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to adverse events
时间窗: -Outcome will be assess at every patient visits Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, and study completion visit
-Dose intensities of study drugs
时间窗: -Outcome will be assess at every patient visits Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, and study completion visit
次要结局
- -ORR at end of treatment by fluorodeoxyglucose positron emission tomography (FDG-PET) as determined by the investigator(-CR rate at end of treatment by FDG-PET as determined by the investigator)
研究者
研究点 (7)
Loading locations...
相似试验
尚未招募
1 期
Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients With Double-Expressor DLBCLNCT07415980Sun Yat-sen University68
招募中
2 期
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in Patients with B-Cell Non-Hodgkin Lymphoma2023-506986-74-00F. Hoffmann-La Roche AG17
招募中
3 期
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants with Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung CancerNon-Small Cell Lung Cancer2025-521124-29-00AbbVie Deutschland GmbH & Co. KG9
尚未招募
2 期
An Exploratory Study of Pertuzumab and Trastuzumab in Combination With Palbociclib and Exemestane as Neoadjuvant Therapy for Triple-Positive Breast CancerBreast CancerNCT07299890Anhui Provincial Cancer Hospital90
Enrolling By Invitation
2 期
Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBCNCT07359404YING FAN60