Cisplatin With Gemcitabine With Dexamethasone in Patients With Aggressive Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00491127
First received: June 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 21, 2007
June 21, 2007
April 2003
Not Provided
To evaluate response rate
Same as current
No Changes Posted
  • To assess toxicity
  • Overall survival
  • Event-free survival
  • Progression - free survival
  • Disease - free survival
  • Duration of response
Same as current
Not Provided
Not Provided
 
Cisplatin With Gemcitabine With Dexamethasone in Patients With Aggressive Non-Hodgkin's Lymphoma
Phase II Study of Cisplatin With Gemcitabine in Fixed Dose Rate Infusion and Dexamethasone in Second-Line in Patients With Aggressive Non-Hodgkin’s Lymphoma

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
  • Drug: gemcitabine
  • Drug: cisplatin
  • Drug: dexamethasone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2004
Not Provided

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00491127
6899, B9E-XM-S315
Yes
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP