multicenter trial to treat patients with relapsed/refractory aggressive non hodgkin lymphoma

Conditions: Leukemia; Lymphoma

Summary: this is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for aplidin® given as 1-hour weekly iv infusion in patients with aggressive non-hodgkin's lymphoma.

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. primary • to assess the anti-tumour activity of aplidin® given as a 1-hour weekly iv infusion, in patients with aggressive non-hodgkin's lymphoma, relapsing or refractory to a prior therapy. secondary * to further investigate the safety profile of aplidin® given as 1-hour weekly iv infusion in this patient population. * to obtain additional pharmacokinetic information for aplidin® given as 1-hour weekly iv infusion in patients with aggressive non-hodgkin's lymphoma.

Eligibility criteria:
inclusion criteria: * written informed consent * histologically confirmed aggressive lymphomas, * patient requires treatment because nhl relapses * measurable disease * recovery from any non-hematological toxicity derived from previous treatments. the presence of alopecia and nci-ctc grade \< 2 symptomatic peripheral neuropathy is allowed. * age \> 18 years. * performance status (ecog) \< 2 * adequate renal, hepatic, and bone marrow function (assessed \< 14 days before inclusion in the study) * left ventricular ejection fraction within normal limits. 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.

Keywords: aplidin aggressive non hodgkin lymphoma leukemia-lymphoma, adult t-cell and b-cell