Conditions: Leukemia Lymphoma
Keywords: Aplidin Aggressive Non Hodgkin Lymphoma Leukemia-Lymphoma, Adult T-Cell and B-cell
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 67
Healthy volunteers: no

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.

Arms:
arm 1: Aplidin® given as a 1-hour weekly IV infusion

Interventions: intervention 1: Aplidin®
Intervention descriptions: intervention 1: 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.

Protocol document: