NL-OMON39626已完成不适用
An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDS4501A in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination with Rituximab in Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma - Genentech Phase I DCS4968g trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
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
- •Patients must meet the following criteria to be eligible for study entry:;* Signed Informed Consent Form(s);* Age * 18 years;* ECOG performance status of 0, 1, or 2;* Life expectancy of at least 12 weeks;* History of one of the following histologically-documented hematologic;malignancies that are expected to express the CD79b antigen and for which no suitable therapy of curative intent or higher priority exists (e.g., standard chemotherapy, autologous stem cell transplant): indolent NHL (including Grades 1-3a FL; MZL [including splenic, nodal,;and extra-nodal]; and SLL), Grade 3b FL, DLBCL, MCL, or CLL;For each patient, an archival or fresh biopsy or tumor specimen (e.g., peripheral blood for CLL patients) must be available locally at the study center prior to dosing to be used to evaluate level of CD79b expression retrospectively following central pathology review.;A lymph-node biopsy to evaluate disease transformation is required for patients with clinical suspicion of transformation. Transformed disease is an eligible diagnosis for enrollment in the NHL cohorts, but also must be relapsed/refractory to standard therapies.;Histologic transformation of an indolent lymphoma to an aggressive histology should be evaluated in any patient who has developed rapid progression of lymphadenopathy, infiltration of uncommon extranodal sites (excluding the bone marrow), development of systemic symptoms (e.g., fevers, night sweats, or weight loss), elevated serum lactate;dehydrogenase and/or hypercalcemia, or the emergence of foci of intense uptake on PET scanning (Freedman and Friedberg 2010).;Note: For the initial dose escalation part of the study, only NHL patients will be enrolled. A separate dose escalation will be initiated in CLL;patients once the NHL dose escalation has cleared the 0.5 mg/kg dose level (see Section 3.1.1).;* Have a clinical indication for treatment as determined by the investigator;* All patients (NHL and B-CLL) must have at least one bi-dimensionally measurable lesion (> 1.5 cm in its largest dimension by computerized;tomography [CT] scan). In addition, where appropriate, for CLL patients, circulating lymphocyte cell assessments will be performed.;* Laboratory values (including patients with renal or hepatic involvement due to NHL/CLL), as follows:;AST and ALT * 2.5 × the upper limit of normal (ULN) Total bilirubin * 1.5 × ULN Platelet count * 75,000/mm3 (unless thrombocytopenia clearly due to marrow involvement of NHL/CLL, and/or disease-related immune thrombocytopenia) ;Absolute neutrophil count (ANC) * 1000/mm3 (without growth factor support,;unless neutropenia is clearly due to marrow involvement of NHL/CLL);Total hemoglobin * 9 g/dL (without transfusion support, unless anemia is;clearly due to marrow involvement of NHL/CLL);Serum creatinine * 2.0 mg/dL or measured creatinine clearance * 50 mL/min;* For all men or women of childbearing potential (unless surgically sterile):;use of adequate methods of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly;A woman is considered not to be of childbearing potential if she is postmenopausal, defined by amenorrhea of * 12 months duration and age * 45 years, or has undergone hysterectomy and/or bilateral oophorectomy.;Use of two forms of effective contraception (e.g., one barrier and one non-barrier method) is required throughout the study and, due to the long half-life of humanized/human m
排除标准
- •-Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before Cycle 1, Day 1;-Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1;Adverse events from any previous treatments must be resolved or stabilized prior to Cycle 1, Day 1, except for neuropathy;-Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1;-Prior allogeneic stem cell transplant;-History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins);- History of other malignancy which 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 history of CNS lymphoma;-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 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 4 weeks prior to Cycle 1, Day 1, other than for diagnosis;-Presence of positive test results for Hepatitis B (Hepatitis B surface antigen [HBsAg] and/or total HB core antibody [anti-HBc]) or Hepatitis C (Hepatitis C virus [HCV] antibody);Patients who are positive for anti-HBc are eligible only if PCR is negative for HBV DNA;Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for the study.;-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 for at least 2 weeks prior to study enrollment and initiation of therapy
研究者
相似试验
进行中（未招募）
1 期
An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN - Zalutumumab PK in SCCHon-Curable Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 12.0Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2009-013317-10-BEGenmab A/S26
进行中（未招募）
1 期
An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN - Zalutumumab PK in SCCHEUCTR2009-013317-10-SKGenmab A/S26
进行中（未招募）
不适用
An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN - Zalutumumab PK in SCCHEUCTR2009-013317-10-GBGenmab A/S26
进行中（未招募）
不适用
An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN - Zalutumumab PK in SCCHon-Curable Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 12.0Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2009-013317-10-HUGenmab A/S26
招募中
2 期
Study To assess the safety and tolerability of AGEN1884 administered in combination with pembrolizumab as a first-line treatment of subjects with metastatic Non Small Cell Lung Cancer (NSCLC).on Small Cell Lung CancerACTRN12617001061325Agenus Inc.26