Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma
- Conditions
- -C82 Follicular lymphoma-C83 Non-follicular lymphoma-C85 Other and unspecified types of non-Hodgkin lymphomaFollicular lymphomaNon-follicular lymphomaOther and unspecified types of non-Hodgkin lymphomaC82C83C85
- Registration Number
- PER-166-08
- Lead Sponsor
- PharmaMar,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• 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 <2 of NCI CTCs is allowed.
• Age> 18 years.
• Functional status (ECOG) <2
• Appropriate renal, hepatic and bone marrow functions (evaluated <14 days before inclusion in the study)
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>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).<br>Measure:Objective Response Rate<br>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<br>
- Secondary Outcome Measures
Name Time Method