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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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00491127
6899, B9E-XM-S315
Yes
Not Provided
Not Provided
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