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

NCT00884286 | Completed Phase 2 Results

• 1 other identifier: APL-B-013-02
• Study Type: interventional
• Target: 67
• Locations: 6 countries
• Sites: 12

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.

Conditions

Leukemia; Lymphoma

Keywords

Aplidin; Aggressive Non Hodgkin Lymphoma; Leukemia-Lymphoma, Adult T-Cell and B-cell

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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).

  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

Secondary Outcomes (6)

• 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

• 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

Study Arms (1)

Arm One

EXPERIMENTAL

Aplidin® given as a 1-hour weekly IV infusion

Drug: Aplidin®

Interventions

Aplidin® 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.

Also known as: plitidepsin

Arm One

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Left ventricular ejection fraction within normal limits.

You may not qualify if:

• 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:
• weeks for nitroso-urea or high dose chemotherapy
• weeks for other chemotherapies or biological agents
• weeks for radiation or radionuclide therapy (6 weeks in case of prior extensive external beam radiation (more than 25% of bone marrow distribution).
• weeks for major prior surgery
• days for any investigational product
• 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

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (12)

Centre Hospitalier Lyon Sud

Lyon, 69495, France

Location

Hôpital Saint- Louis

Paris, 75475, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

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

Bologna, 40138, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Ospedaliero Universitaria de Modena

Modena, 41100, Italy

Location

Instituto Nacional de Enfermedades Neoplásicas (INEN)

Surquillo, Lima region, 34, Peru

Location

Hospital Español Auxilio Mutuo de Puerto Rico Inc.

San Juan, 00919, Puerto Rico

Location

Hospital Clinico de Barcelona

Barcelona, 08036, Spain

Location

Hospital Morales Meseguer

Murcia, 3008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37707, Spain

Location

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 23065525 DERIVED

MeSH Terms

Conditions

Leukemia; Lymphoma

Interventions

plitidepsin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Clinical Development Department of PharmaMar´s Oncology,Business Unit.,
• Organization: Pharma Mar, S.A.

clinicaltrials@pharmamar.com

+34 918466000

Study Officials

• Vincent Ribrag, MD

  Institut Gustave Roussy, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: December 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 25, 2018
• Results First Posted: March 29, 2018

Record last verified: 2011-02

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); PE (1); CH (1); ES (3); FR (3); IT (3)