None listed
Conditions
Interventions
Aplidin Type of group
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.
Sponsors
PharmaMar,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Obtain written informed consent before the start of any specific study procedure. • Histologically confirmed aggressive lymphomas • The patient requires treatment because NHL has recurred after the response to chemotherapy at standard or high doses + germ cell transplantation, or NHL is refractory (that is, it has not been possible to achieve at least RC, RP or EE) at most recent chemotherapy. • Autotransplantation and / or germ cell allotransplantation is allowed. In case of hematopoietic germ cell allogeneic transplantation (HSCT), the patient must be without immunosuppressive medication before being able to be included. • The disease is measurable: existence of a two-dimensional lesion larger than 2 cm in its largest diameter or malignant lymphocytosis greater than 5 x 10 ^ / L. Another procedure for the formulation of measurable disease could be allowed in a given case if approved by PharmaMar. • Resolution of all non-hematological toxicity resulting from previous treatments. The presence of alopecia and symptomatic peripheral neuropathy of grade 18 years. • Functional status (ECOG) <2 • Appropriate renal, hepatic and bone marrow functions (evaluated <14 days before inclusion in the study)
Exclusion criteria
Exclusion criteria: • Pretreatment with Aplidin® • Concomitant treatment with any antilinfoproliferative agent, including glucocorticoids at a daily dose greater than 10 mg of prednisone or equivalent, unless they were indicated for symptom control and disease progression had been documented while the patient was on steroids. • Acute lymphoblastic leukemia. • Lymphoma in CNS. • Lymphoma associated with HIV. • Previous gene therapy with viral vectors. • More than three previous lines of systemic biological agents or systemic chemotherapies. (Bone marrow transplantation and germ cell transplantation as consolidation therapy of a previous response are considered as a chemotherapy line). • Washing periods from the end of the previous treatment under: 6 weeks for chemotherapy with nitrosoureas or high-dose chemotherapy, 3 weeks for other chemotherapies or biological agents, 4 weeks for radiotherapy or radionuclide treatment (6 weeks in the case of previous extensive external radiotherapy (distribution over more than 25% of bone marrow)), 4 weeks for previous major surgery, 30 days for any product under investigation, 4 weeks for immunosuppressive treatment after germ cell allogeneic transplantation hematopoietic • Pregnant or breastfeeding women. • Men and women of childbearing age who do not use effective contraceptive methods • History of another neoplastic disease, except: Nonmelanoma skin cancer, Carcinoma in situ of any area, Any other neoplasm treated curatively and without evidence of disease for at least 10 years. • Known cerebral or leptomeningeal involvement. • Other relevant adverse clinical conditions or situations • Treatment with any product under investigation within the period of 30 days prior to 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 indicated in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary objective of the study was the exploration of the efficacy of plitidepsin when given as a weekly 1-hour infusion on Days 1, 8 and 15 in 4-week cycles to patients with relapsed or refractory aggressive non-Hodgkins Lymphoma. The primary efficacy endpoint was the Objective Response Rate, defined as the combined rate of Complete Response (CR), Unconfirmed Complete Response (CRu) and Partial Response (PR) following the definition of response according to the International Working Group (IWG) criteria for Non-Hodgkins Lymphoma (NHL). Measure:Objective Response Rate Timepoints:All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Time to response onset was defined as the time from the first day of plitidepsin treatment to the first documentation of response. Measure:Time to Response Onset Timepoints:All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ; Outcome name:Duration of response was defined as the time from the first documented objective response (CR, CRu or PR) to disease progression or death. Patients who had not progressed or died were to have their duration censored at the date of their last disease assessment. Measure:Duration of Response Timepoints:All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ; Outcome name:Time to progression (TTP) was to be calculated from the first day of plitidepsin treatment to the date of disease progression. Measure:Time to Progression Timepoints:All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ; Outcome name:Time to subsequent therapy was to be calculated from the first infusion of the study drug to the start date of the subsequent therapy. Patients without subsequent therapy were to be censored at their last reported date. Measure:Time to Subsequent Chemotherapy Timepoints:All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ; Outcome name:Progression-free survival (PFS) was to be calculated from the date of registration to the date of first objective disease progression or death from any cause. Patients who were lost to follow-up without documentatio | — |
Countries
France, Italy, Peru, Puerto Rico, Spain, Switzerland
Contacts
Public ContactMariana Abdala
World Wide Clinical Research del Peru S.A.C.
Outcome results
None listed