Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma

Exclusion Criteria

• •Prior therapy with Aplidin®.
• •Concomitant therapy with any anti-lymphoproliferative agent
• •Acute lymphoblastic leukemia.
• •CNS lymphoma.
• •HIV-associated lymphoma.
• •Prior gene therapy with viral vectors.
• •More than three previous lines of systemic biological agents or chemotherapies. Wash-out periods since the end of the precedent therapy less than:
• •* 6 weeks for nitroso-urea or high dose chemotherapy
• •* 3 weeks for other chemotherapies or biological agents
• •* 4 weeks for radiation or radionuclide therapy (6 weeks in case of prior extensive external beam radiation (more than 25% of bone marrow distribution).
• •* 4 weeks for major prior surgery
• •* 30 days for any investigational product
• •* 4 weeks for immunosuppressive therapy after allogeneic hematopoietic stem cell transplantation.
• •Pregnant or lactating women.
• •Men and women of reproductive potential who are not using effective contraceptive methods
• •History of another neoplastic disease. Exceptions: Non-melanoma skin cancer,cCarcinoma in situ of any site,any other cancer curatively treated and no evidence of disease for at least 10 years.
• •Known cerebral or leptomeningeal involvement.
• •Other relevant diseases or adverse clinical conditions
• •Treatment with any investigational product in the 30 days period before inclusion in the study.
• •Known hypersensitivity to Aplidin®, mannitol, cremophor EL, or ethanol
• •Limitation of the patient's ability to comply with the treatment or follow-up protocol.