Status:
COMPLETED
Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma
Lead Sponsor:
PharmaMar
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 •...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00884286
Start Date
December 1 2004
End Date
June 1 2010
Last Update
April 25 2018
Active Locations (12)
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1
Centre Hospitalier Lyon Sud
Lyon, France, 69495
2
Hôpital Saint- Louis
Paris, France, 75475
3
Institut Gustave Roussy
Villejuif, France, 94805
4
Istituto di ematologia e oncologia medica "L. e. A. Seragnoli"
Bologna, Italy, 40138