EUCTR2004-002692-16-ES进行中（未招募）1 期
A Phase II Multicenter,Open-Label, Clinical And Pharmacokinetic Study Of Aplidin® As A 1-Hour Weekly IV Infusion, In Patients With Relapsed Or Refractory Indolent Non-Hodgkin’s Lymphoid Neoplasms.
PharmaMar SA unipersonal0 个研究点目标入组 0 人开始时间: 2005年3月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent obtained before starting any study-specific procedure..
- •2.Histologically confirmed indolent lymphoid neoplasms, including the following:
- •2.1.Mature (peripheral) B-cell neoplasms
- •·B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma
- •·B-cell prolymphocytic leukemia
- •·Lymphoplasmacytic lymphoma
- •·Splenic marginal zone B-cell lymphoma (1/2 villous lymphocytes)
- •·Hairy cell leukemia
- •·Extranodal marginal zone B-cell lymphoma of MALT type
- •·Nodal marginal zone B-cell lymphoma (1/2 monocytoid B cells)
- •·Follicular lymphoma (except large cell)
- •·Mantle-cell lymphoma (except diffuse pattern or blastoid variant)
- •2.2 Mature (peripheral) T-cell neoplasms
- •·T-cell prolymphocytic leukemia
- •·T-cell granular lymphocytic leukemia
- •·Mycosis fungoides/Sezary syndrome
- •3.The lymphoproliferative malignancy either relapses following a response to standard or high-dose chemotherapy , or is refractory to previous chemotherapy and there is a clinical need to start a new chemotherapy.
- •3.1.Relapsed disease is defined as development of any of the following after a prior response of at least 6 months duration:
- •·Lymphadenopathy
- •·Splenomegaly
- •·Malignant lymphocytosis greater than 5000 x 109/L
- •·Infiltration of the bone marrow with malignant lymphocytes
- •3.2.Refractory disease
- •·No partial response (PR) to prior therapy OR
- •·Complete response or PR of less than 6 months duration
- •4.Disease is measurable: existence of a bidimensional lesion greater than 2 cm in its longer diameter or malignant lymphocytosis greater than 5000 x 109/L
- •5.Recovery from any non-hematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade < 2 symptomatic peripheral neuropathy is allowed.
- •6.Age > 18 years.
- •7.Performance status (ECOG) < 2 (Appendix 4)
- •8.Adequate renal, hepatic, and bone marrow function (assessed < 14 days before inclusion in the study):
- •8.1.Neutrophil count ³ 1.5 x 109/L
- •8.2.Platelet count ³ 100 x 109/L
- •8.3.Haemoglobin ³ 8.0 g/dL
- •8.4.Creatinine clearance ³ 40 ml/min (calculated from the Cockcroft and Gault formula, Appendix 5)
- •8.5.Serum bilirubin * 1.5 mg/dL and alkaline phosphatase * 2.5 x ULN (< 5 x ULN in case of extensive bone metastases)
- •8.6.AST, ALT < 2.5 x ULN (< 5 x ULN in case of liver metastasis).
- •8.7.Albumin > 25 g/L
- •9.Left ventricular ejection fraction within normal limits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior therapy with Aplidin®.
- •2.Concomitant therapy with any anti-lymphoproliferative agent, including glucocorticoids at a daily dose greater than 10 mg prednisone or equivalent, except when they were indicated for symptom control and disease progression was documented while on esteroids.
- •3.Aggressive histological conversion.
- •4.HIV-associated lymphoma
- •5.CNS lymphoma
- •6.More than five previous lines of systemic biological agents or chemotherapies.
- •7.Prior gene therapy with viral vectors.
- •8.Wash-out periods since the end of the precedent therapy less than:
- •8.1.6 weeks for nitroso-urea or high dose chemotherapy
- •8.2.4 weeks for other chemotherapies or biological agents
- •8.3.4 weeks for radiation or radionuclide therapy (6 weeks in case of prior extensive external beam radiation (more than 25% of bone marrow distribution).
- •8.4.4 weeks for major prior surgery
- •8.5.30 days for any investigational product
- •9.Pregnant or lactating women.
- •10.Men and women of reproductive potential who are not using effective contraceptive methods (one or more of the following):
- •10.1.Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for at least 6 months after completion or premature discontinuation from the study to account for elimination of the investigational drug; or,
- •10.2.Patient or patient’s partner physical sterilization; or,
- •10.3.One of the following, for female patients or female partner of male patients:
- •·Implants of levonorgestrel; or,
- •·Injectable progestogen; or,
- •·Oral contraceptive (combined or progestogen only; subject taking oral contraceptives should have been on a stable regimen for at least 2 months prior to screening),or,
- •·Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,
- •·Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or,
- •·Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year.
- •11.History of another neoplastic disease. The exceptions are:
- •11.1.Non-melanoma skin cancer
- •11.2.Carcinoma in situ of any site
- •11.3.Any other cancer curatively treated and no evidence of disease for at least 10 years.
- •12.Known symptomatic cerebral or leptomeningeal involvement.
- •13.Other relevant diseases or adverse clinical conditions:
- •13.1.Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
- •13.2.Uncontrolled arterial hypertension (i.e. current arterial diastolic blood pressure over 100 mmHg).
- •13.3.Uncontrolled cardiac supraventricular arrhythmias (i.e. requiring a change in medication within the last 3 months or a hospital admission within the past 6 months).
- •13.4.Cardiac ventricular arrhythmia.
- •13.5.History of significant neurological or psychiatric disorders
- •13.6.Active infection; infection by HIV, HBV or HCV
- •13.7.Myopathy or any clinical situation that causes significant and persistent elevation of CK (>2.5 ULN in two different determinations performed with one week appart)
- •13.8.Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)
- •13.9.Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months)
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