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

Not Applicable

Completed

• Conditions: -C82 Follicular lymphoma-C83 Non-follicular lymphoma-C85 Other and unspecified types of non-Hodgkin lymphoma; Follicular lymphoma; Non-follicular lymphoma; Other and unspecified types of non-Hodgkin lymphoma; C82; C83; C85

• Registration Number: PER-166-08
• Lead Sponsor: PharmaMar,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-09
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

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 <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)

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified