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

NCT ID: NCT00884286

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2010-06-30

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.

Conditions

Leukemia; Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm One

Aplidin® given as a 1-hour weekly IV infusion

Group Type: EXPERIMENTAL

Aplidin®

Intervention Type: DRUG

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.

Interventions

Aplidin®

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.

Intervention Type: DRUG

Other Intervention Names

plitidepsin

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).
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaMar

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Ribrag, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Gustave Roussy, France

Locations

Centre Hospitalier Lyon Sud

Lyon, , France

Hôpital Saint- Louis

Paris, , France

Institut Gustave Roussy

Villejuif, , France

Istituto di ematologia e oncologia medica "L. e. A. Seragnoli"

Bologna, , Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Ospedaliero Universitaria de Modena

Modena, , Italy

Instituto Nacional de Enfermedades Neoplásicas (INEN)

Surquillo, Lima region, Peru

Hospital Español Auxilio Mutuo de Puerto Rico Inc.

San Juan, , Puerto Rico

Hospital Clinico de Barcelona

Barcelona, , Spain

Hospital Morales Meseguer

Murcia, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Bellinzona, , Switzerland

Countries

France; Italy; Peru; Puerto Rico; Spain; Switzerland

References

Ribrag 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.

Reference Type: DERIVED

PMID: 23065525 (View on PubMed)

Other Identifiers

APL-B-013-02

Identifier Type: -

Identifier Source: org_study_id