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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 17, 2009

Last Updated Date

February 10, 2011

Start Date ^ICMJE

December 2004

Primary Completion Date

July 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00884286 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To investigate the safety profile of Aplidin® in the patient population and to obtain additional pharmacokinetic information for the drug [ Time Frame: 1 year ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Leukemia
Lymphoma

Intervention ^ICMJE

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

Study Arms

Experimental: Arm One

Aplidin® given as a 1-hour weekly IV infusion

Intervention: Drug: Aplidin®

Publications *

Ribrag V, Caballero D, Fermé 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France, Italy, Peru, Puerto Rico, Spain, Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00884286

Other Study ID Numbers ^ICMJE

APL-B-013-02

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

PharmaMar USA Inc

Study Sponsor ^ICMJE

PharmaMar

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Vincent Ribrag, MD

Institut Gustave Roussy, France

PRS Account

PharmaMar

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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