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
18 Years
N/A
Both
Leukemia, Lymphoma
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Vincent Ribrag, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Gustave Roussy, France
Authority:
United States: Food and Drug Administration
Study ID:
APL-B-013-02
NCT ID:
NCT00884286
Start Date:
December 2004
Completion Date:
July 2010
Related Keywords:
- Leukemia
- Lymphoma
- Aplidin
- Aggressive Non Hodgkin Lymphoma
- Leukemia-Lymphoma, Adult T-Cell and B-cell
- Aggression
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
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