Cisplatin With Gemcitabine With Dexamethasone in Patients With Aggressive Non-Hodgkin's Lymphoma
- Conditions
- Non-Hodgkin's Lymphoma
- Registration Number
- NCT00491127
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
-
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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate response rate
- Secondary Outcome Measures
Name Time Method To assess toxicity Overall survival Event-free survival Progression - free survival Disease - free survival Duration of response
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇪🇸Madrid, Spain