EUCTR2004-001117-34-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 aggressive non-Hodgkin’s Lymphoma.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 aggressive lymphomas, including the following:
- •2.1 B-Cell neoplasms.
- •2.1.1 Precursor B-cell neoplasm
- •2.1.1.1.1 Precursor B-lymphoblastic lymphoma
- •2.1.2 Mature (peripheral) B-cell neoplasms
- •2.1.2.1. 1 Follicular lymphoma (histologic conversion)
- •2.1.2.1. 2 Mantle-cell lymphoma (diffuse pattern or blastic variant)
- •2.1.2.1. 3 Diffuse large B-cell lymphoma
- •2.1.2.1. 4 Mediastinal large B-cell lymphoma
- •2.1.2.1. 5 Burkitt’s lymphoma/Burkitt cell leukemia
- •2.2 T-cell and NK-cell neoplasms
- •2.2.1 Precursor T-cell neoplasm
- •2.2.1.1.1 Precursor T-lymphoblastic lymphoma
- •2.2.2 Mature (peripheral) T-cell neoplasms
- •2.2.2.1.1 Aggressive NK-cell leukemia
- •2.2.2.1.2 Adult T-cell lymphoma/leukemia (HTLV1)
- •2.2.2.1.3 Extranodal NK/T-cell lymphoma, nasal type
- •2.2.2.1.4 Enteropathy-type T-cell lymphoma
- •2.2.2.1.5 Hepatosplenic gamma-delta T-cell lymphoma
- •2.2.2.1.6 Subcutaneous panniculitis-like T-cell lymphoma
- •2.2.2.1.7 Anaplastic large-cell lymphoma, T/null cell, primary cutaneous type
- •2.2.2.1.8 Peripheral T-cell lymphoma, not otherwise characterized
- •2.2.2.1.9 Angioimmunoblastic T-cell lymphoma
- •2.2.2.1.10 Anaplastic large-cell lymphoma, T/null cell, primary systemic type
- •3. Patient requires treatment because NHL relapses following a response to standard chemotherapy or high dose chemotherapy , or NHL is refractory (i.e. failure to achieve al least CR, PR or SD) to its more recent chemotherapy.
- •4. Prior autologous and/or allogeneic stem cell transplantation is allowed. In case of allogeneic hematopoietic stem cell transplantation (HSCT), patient has to be off immunosuppressive agents before he can enrolled.
- •5. 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
- •6. Recovery from any non-hematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade < 2 symptomatic peripheral neuropathy is allowed.
- •7. Age > 18 years.
- •8. Performance status (ECOG) < 2 (Appendix 2)
- •9. Adequate renal, hepatic, and bone marrow function (assessed < 14 days before inclusion in the study):
- •oNeutrophil count ³ 1.5 x 109/L
- •oPlatelet count ³ 100 x 109/L
- •oHaemoglobin ³ 8.0 g/dL
- •oCreatinine clearance ³ 40 ml/min (calculated from the Cockcroft and Gault formula, Appendix 3)
- •oSerum bilirubin * 1.5 mg/dL and alkaline phosphatase * 2.5 x ULN (< 5 x ULN in case of extensive bone involvement)
- •oAST, ALT < 2.5 x ULN (< 5 x ULN in case of liver involvement).
- •oAlbumin > 25 g/L
- •10. 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. Acute lymphoblastic leukemia.
- •4. CNS lymphoma.
- •5. HIV-associated lymphoma.
- •6. Prior gene therapy with viral vectors.
- •7. More than three previous lines of systemic biological agents or chemotherapies. (Bone marrow or stem cell transplantation as consolidation therapy of a previous response is understood as one line of chemotherapy).
- •8. Wash-out periods since the end of the precedent therapy less than:
- •o6 weeks for nitroso-urea or high dose chemotherapy
- •o4 weeks for other chemotherapies or biological agents
- •o4 weeks for radiation or radionuclide therapy (6 weeks in case of prior extensive external beam radiation (more than 25% of bone marrow distribution).
- •o4 weeks for major prior surgery
- •o30 days for any investigational product
- •o4 weeks for immunosuppressive therapy after allogeneic hematopoietic stem cell transplantation.
- •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):
- •·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,
- •·Patient or patient’s partner physical sterilization; or,
- •·One of the following, for female patients or female partner of male patients:
- •oImplants of levonorgestrel; or,
- •oInjectable progestogen; or,
- •oOral 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,
- •oAny 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,
- •oDouble barrier method (2 physical barriers or 1 physical barrier plus spermicide); or,
- •oAny 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:
- •oNon-melanoma skin cancer
- •oCarcinoma in situ of any site
- •oAny other cancer curatively treated and no evidence of disease for at least 10 years.
- •12. Known cerebral or leptomeningeal involvement.
- •13. Other relevant diseases or adverse clinical conditions:
- •oCongestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
- •oUncontrolled arterial hypertension (i.e. current arterial diastolic blood pressure over 100 mmHg).
- •oUncontrolled cardiac supraventricular arrhythmias (i.e. requiring a change in medication within the last 3 months or a hospital admission within the past 6 months).
- •oCardiac ventricular arrhythmia.
- •oHistory of significant neurological or psychiatric disorders
- •oActive infection; infection by HIV, HBV or HCV
- •oMyopathy or any clinical situation that causes significant and persistent elevation of CK (>2.5 ULN in two different determinations performed with one week appart)
- •oSignificant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)
- •oUncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism
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