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
Overview
- Phase
- Phase 2
- Intervention
- Aplidin®
- Conditions
- Leukemia
- Sponsor
- PharmaMar
- Enrollment
- 67
- Locations
- 12
- Primary Endpoint
- Objective Response Rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed Description
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. Primary • To assess the anti-tumour activity of Aplidin® given as a 1-hour weekly IV infusion, in patients with aggressive non-Hodgkin's Lymphoma, relapsing or refractory to a prior therapy. Secondary * To further investigate the safety profile of Aplidin® given as 1-hour weekly IV infusion in this patient population. * To obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.
Investigators
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).
Arms & Interventions
Arm One
Aplidin® given as a 1-hour weekly IV infusion
Intervention: Aplidin®
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: 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
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
- Time to Subsequent Chemotherapy(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)
- Progression-free Survival(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)
- Overall Survival(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)
- Time to Response Onset(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)
- Duration of Response(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)
- Time to Progression(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)