Clinical trial · Interventional
Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin 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
NCT00884286CI-TRIAL-00032660completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aplidin® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm One
- description
- Aplidin® given as a 1-hour weekly IV infusion
- interventionNames
- Drug: Aplidin®
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 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
- description
- 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-Hodgkin's 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-Hodgkin's Lymphoma (NHL).
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRibrag V, Caballero D, Ferme C, Zucca E, Arranz R, Briones J, Gisselbrecht C, Salles G, Gianni AM, Gomez H, Kahatt C, Corrado C, Szyldergemajn S, Extremera S, de Miguel B, Cullell-Young M, Cavalli F. Multicenter phase II study of plitidepsin in patients with relapsed/refractory non-Hodgkin's lymphoma. Haematologica. 2013 Mar;98(3):357-63. doi: 10.3324/haematol.2012.069757. Epub 2012 Oct 12. PMID 23065525