Non-Hodgkin's Lymphoma
Conditions
Brief summary
The purpose of this study it to evaluate efficacy of gemcitabine with cisplatin and dexamethasone in patients with aggressive non-Hodgkin's lymphoma who have previously progressed on first line of chemotherapy with anthracyclines.
Interventions
DRUGgemcitabine
DRUGcisplatin
DRUGdexamethasone
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patients must have a histological diagnosis of aggressive non-Hodgkin's lymphoma including the following sub-categories of the WHO classification: * Diffuse large B-cell lymphoma and its variants (immunoblastic, Burkitt-like, sclerosis of mediastinum, large B-cell MALT, rich in T-cells and anaplastic B-cell lymphoma) * Peripheral T-cell lymphoma * Anaplastic lymphoma of large T-cells /null cells * Patients are eligible if they have documented evidence of progression after prior first-line chemotherapy containing anthracyclines associated or not with Rituximab. Patients with refractory disease to first line of treatment are also eligible. * ECOG PS (performance status) less than or equal to 2 * Presence of bidimensionally measurable disease in accordance with WHO criteria.
Exclusion criteria
* Involvement of the CNS. * Any medical condition which contraindicates the degree of hydration required for the safe use of cisplatin. * Intermediate degree lymphoma derived from the malignant transformation of a previous low-grade lymphoma. * Active infection (in the opinion of the investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | — |
| Event-free survival | — |
| To assess toxicity | — |
| Disease - free survival | — |
| Duration of response | — |
| Progression - free survival | — |
Countries
Spain
Outcome results
None listed