NL-OMON39673已完成2 期
A randomized, open-label, multicenter, phase II trial evaluating the safety and activity of DCDT2980S in combination with rituximab or DCDS4501A in combination with rituximab in patients with relapsed or refractory B-cell non Hodgkin's lymphoma. - Genentech GO27834 study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Signed Informed Consent Form(s)
- •Age >= 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status
- •of 0, 1, or 2
- •Life expectancy of at least 12 weeks
- •History of histologically documented relapsed or refractory Grades 1*3a FL,
- •or relapsed or refractory DLBCL
- •Availability of an archival or freshly biopsied tumor tissue sample must be
- •confirmed for study enrollment.
- •Have a clinical indication for treatment as determined by the investigator
- •Must have at least one bi-dimensionally measurable lesion (> 1.5 cm in its
- •largest dimension by CT scan or MRI)
- •Laboratory values (including patients with hepatic or renal involvement), as
- •AST and ALT <= 2.5 × the upper limit of normal (ULN)
- •Total bilirubin <= 1.5 × ULN
- •Protocol: DCDT2980S and DCDS4501A*Genentech, Inc.
- •54/P GO27834
- •Platelet count >= 75,000/mm3 (unless thrombocytopenia clearly due to
- •marrow involvement of NHL, and/or disease-related immune
- •thrombocytopenia)
- •Absolute neutrophil count >= 1000/mm3 (without growth factor support,
- •unless neutropenia clearly due to marrow involvement of NHL)
- •Total hemoglobin >= 9 g/dL (without transfusion support >14 days prior to
- •screening, unless anemia clearly due to marrow involvement of NHL)
- •Serum creatinine <= 2.0 mg/dL or measured creatinine clearance >= 50 mL/min
排除标准
- •Prior use of any monoclonal antibody, radioimmunoconjugate or antibodydrug
- •conjugate within 4 weeks before Cycle 1, Day 1
- •Treatment with radiotherapy, chemotherapy, immunotherapy,
- •immunosuppressive therapy, or any investigational anti-cancer agent within
- •2 weeks prior to Cycle 1, Day 1
- •Adverse events except for sensory neuropathy from any previous
- •treatments must be resolved or stabilized to Grade <= 2 prior to Cycle 1,
- •Completion of autologous stem cell transplant within 100 days prior to
- •Cycle 1, Day 1
- •Prior allogeneic stem cell transplant
- •Eligibility for autologous SCT (patients with relapsed or refractory DLBCL)
- •History of transformation of indolent disease to DLBCL
- •History of severe allergic or anaphylactic reactions to monoclonal antibody
- •therapy (or recombinant antibody-related fusion proteins)
- •History of other malignancy that could affect compliance with the protocol or
- •interpretation of results
- •Patients with a history of curatively treated basal or squamous cell
- •carcinoma of the skin or in situ carcinoma, e.g. of the cervix or breast, are
- •allowed. Patients with a malignancy that has been treated with curative
- •intent will also be allowed if the malignancy has been in remission without
- •treatment for >= 2 years prior to Cycle 1, Day 1.
- •Current or past history of CNS lymphoma
- •Current Grade > 1 peripheral neuropathy
- •Evidence of significant, uncontrolled concomitant diseases which could affect
- •compliance with the protocol or interpretation of results, including significant
- •cardiovascular disease (such as New York Heart Association Class III or
- •IV cardiac disease, myocardial infarction within the last 6 months,
- •unstable arrhythmias, or unstable angina) or significant pulmonary disease
- •(including obstructive pulmonary disease and history of bronchospasm)
- •Known active bacterial, viral, fungal, mycobacterial, parasitic, or other
- •infection (excluding fungal infections of nail beds) at study enrollment, or any
- •major episode of infection requiring treatment with IV antibiotics or
- •hospitalization (relating to the completion of the course of antibiotics) within
- •4 weeks prior to Cycle 1, Day 1
- •Recent major surgery within 6 weeks prior to Cycle 1, Day 1, other than
- •for diagnosis
- •Presence of positive test results for Hepatitis B (HBsAg and/or total
- •Hepatitis B core antibody [anti-HBc]) or Hepatitis C (HCV antibody)
- •Patients who are positive for anti-HBc are eligible only if PCR is negative
- •for HBV DNA and it is believed by both the investigator and Medical
- •Monitor to be in the patient*s best interest to participate.
- •Patients who are positive for HCV antibody must be negative by for HCV
- •by PCR to be eligible for study participation
- •Known history of HIV seropositive status
- •Women who are pregnant or lactating
- •Ongoing corticosteroid use > 30 mg/day prednisone or equivalent
- •Patients receiving corticosteroid treatment <= 30 mg/day prednisone or
- •equivalent must be documented to be on a stable dose prior to study
- •enrollment and initiation of therapy
- •For female patients of childbearing potential and male patients with female
- 另有 3 项未显示
研究者
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