Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Aggression
Intervention: Aplidin®
Intervention description: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aplidin; Aggressive Non Hodgkin Lymphoma; Leukemia-Lymphoma, Adult T-Cell and B-cell

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.
    

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.