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

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ClinicalTrials.gov Identifier: NCT00884286
Recruitment Status : Completed
First Posted : April 20, 2009
Results First Posted : March 29, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
PharmaMar

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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Drug: Aplidin® Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2004
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time to Response Onset [ 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 ]
    Time to response onset was defined as the time from the first day of plitidepsin treatment to the first documentation of response.

  2. Duration of Response [ 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 ]
    Duration of response was defined as the time from the first documented objective response (CR, CRu or PR) to disease progression or death. Patients who had not progressed or died were to have their duration censored at the date of their last disease assessment.

  3. Time to Progression [ 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 ]
    Time to progression (TTP) was to be calculated from the first day of plitidepsin treatment to the date of disease progression.

  4. Time to Subsequent Chemotherapy [ 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 ]
    Time to subsequent therapy was to be calculated from the first infusion of the study drug to the start date of the subsequent therapy. Patients without subsequent therapy were to be censored at their last reported date.

  5. Progression-free Survival [ 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 ]

    Progression-free survival (PFS) was to be calculated from the date of registration to the date of first objective disease progression or death from any cause. Patients who were lost to follow-up without documentation of progression were to be censored at the last date they were assessed and found progression-free.

    A patient receiving a new treatment in the absence of documented progression was to be considered as progressing at the time of re-treatment.


  6. Overall Survival [ 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 ]
    Overall survival (OS) was to be calculated from the date of registration to the date of death from any cause. Patients with no documented death were to be censored at the last date they were known to be alive.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Instituto Nacional de Enfermedades Neoplásicas (INEN)
Surquillo, Lima, Peru, 34
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT00884286     History of Changes
Other Study ID Numbers: APL-B-013-02
First Posted: April 20, 2009    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: April 25, 2018
Last Verified: February 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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