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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491127
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : June 25, 2007
Information provided by:
Eli Lilly and Company

June 21, 2007
June 25, 2007
June 25, 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
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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
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
Same as current
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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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