NCT00850057已完成1 期
A Phase 1, Open Label, Dose-escalation, Pharmacodynamic Study of Intranodal Injection of Adenovirus-CD154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35) when injected directly into lymph nodes of patients with CLL/SLL.
研究概览
简要总结
Primary Objectives
- To determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35) when it is injected directly into the lymph nodes of patients with CLL or SLL.
Secondary Objectives
- To determine and monitor clinical and biological responses in patients treated with injections of Ad-ISF35.
- To determine how ISF35 works in CLL/SLL patients' cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of B-cell CLL/SLL including
- •Lymphocytosis of monoclonal B-cells co-expressing ≥ one B-cell marker (CD19, CD20, or CD23) and CD5 in peripheral blood or lymph node AND
- •Bone marrow with ≥ 30% mononuclear cells having the CLL/SLL phenotype.
- •Presence of at least ONE single accessible AND palpable lymph node in the cervical, supraclavicular, axillary, or inguinal regions. The size of the lymph nodes must be larger than 2x2 cm in the horizontal and perpendicular axes.
- •Intermediate or High risk, poor prognosis CLL/SLL
- •Indication for treatment as defined by the NCI Working Group Guidelines:
- •Massive (i.e. > 6 cm below the left costal margin) or progressive splenomegaly OR
- •Massive lymph nodes or nodal clusters (i.e. > 10 cm in longest diameter), or progressive lymphadenopathy OR
- •Grade 2 or 3 fatigue OR
- •Fever ≥ 100.5˚F or night sweats for greater than 2 weeks without documented infection OR
- •Presence of weight loss ≥ 10% over the preceding 6 months OR
- •Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period or an anticipated doubling time of less than 6 months.
- •Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and / or thrombocytopenia.
- •Autoimmune anemia and / or thrombocytopenia poorly responsive to corticosteroid therapy.
- •Males and females 18 years of age and older
- •Laboratory parameters as specified below:
- •Hematologic: Hemoglobin ≥ 10 g/dL (may be post-transfusion); platelet count ≥ 50 x103/mm3
- •Hepatic: Total Bilirubin < 2 X ULN, and ALT and AST < 2 x ULN
- •Renal: Creatinine ≤ 2 X ULN
- •ECOG Performance Status ≤ 2
- •Anticipated survival of at least 3 months
- •For men and women of child-producing potential, use of effective barrier contraceptive methods during the study and for one month following treatment.
- •Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
- •Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis A, B, C within 30 days of registration. (Antibody, antigen and nucleic acid tests acceptable, depending on institutional standards.).
排除标准
- •Pregnant or nursing women
- •Treatment with chemotherapy or monoclonal antibody within 28 days prior to entering the study.
- •Treatment with chemotherapy or monoclonal antibody during the time of participation in this trial.
- •Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- •Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
- •Participation in any investigational drug study within 28 days prior to ISF35 administration. (Patient must have recovered from all acute effects of previously administered investigational agents)
- •History of malignancy other than CLL within five years of registration, except patients with adequately treated basal, squamous cell carcinoma or localized cervical cancer.
- •Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis.
- •Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study's endpoints.
结局指标
主要结局
Determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35) when injected directly into lymph nodes of patients with CLL/SLL.
时间窗: 2 years
次要结局
- Determine and monitor clinical and biological responses in patients treated with intranodal injections of Ad-ISF35.(2 years)
- Determine pharmacodynamic (PD) parameters in patients treated with intranodal injections of ISF35.(2 years)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients With Cystic FibrosisCystic FibrosisNCT00004533National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)19
招募中
1 期
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.Malignant Glioma of BrainMalignant AstrocytomaBrain CancerGlioblastomaAstrocytomaGliomaGlioblastoma MultiformeBrain TumorGBMNCT05686798Henry Ford Health System18
已完成
1 期
A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid TumorsTumorsNCT00422682Sanofi136
进行中（未招募）
1 期
Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1Head and Neck Squamous Cell CarcinomaMelanomaNCT05222932TILT Biotherapeutics Ltd.15
已完成
1 期
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of E6201 in Subjects With Advanced Solid TumorsAdvanced Solid TumorsNCT00794781Eisai Inc.55