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

This study has been completed.
Sponsor:
Information provided by:
PharmaMar
ClinicalTrials.gov Identifier:
NCT00884286
First received: April 17, 2009
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: Aplidin®
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by PharmaMar:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the safety profile of Aplidin® in the patient population and to obtain additional pharmacokinetic information for the drug [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: December 2004
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm One
Aplidin® given as a 1-hour weekly IV infusion
Drug: 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.
Other Name: plitidepsin

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884286

Locations
France
Centre Hospitalier Lyon Sud
Lyon, France, 69495
Hôpital Saint- Louis
Paris, France, 75475
Institut Gustave Roussy
Villejuif, France, 94805
Italy
Istituto di ematologia e oncologia medica "L. e. A. Seragnoli"
Bologna, Italy, 40138
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
Ospedaliero Universitaria de Modena
Modena, Italy, 41100
Peru
Centro de Especialidades Médicas Universal S.A.
San Borja - Lima, Peru, 41
Puerto Rico
Hospital Español Auxilio Mutuo de Puerto Rico Inc.
San Juan, Puerto Rico, 00919
Spain
Hospital Clinico de Barcelona
Barcelona, Spain, 08036
Hospital Morales Meseguer
Murcia, Spain, 3008
Hospital Universitario de Salamanca
Salamanca, Spain, 37707
Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
Sponsors and Collaborators
PharmaMar
Investigators
Principal Investigator: Vincent Ribrag, MD Institut Gustave Roussy, France
  More Information

No publications provided by PharmaMar

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PharmaMar USA Inc
ClinicalTrials.gov Identifier: NCT00884286     History of Changes
Other Study ID Numbers: APL-B-013-02
Study First Received: April 17, 2009
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by PharmaMar:
Aplidin
Aggressive Non Hodgkin Lymphoma
Leukemia-Lymphoma, Adult T-Cell and B-cell

Additional relevant MeSH terms:
Aggression
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014