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NCT Number: NCT00884286

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Lyon Sud, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: plitidepsin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

PharmaMar

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Apr 20, 2009
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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