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

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: gemcitabine Drug: cisplatin Drug: dexamethasone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2003
Actual Study Completion Date : June 2004

Primary Outcome Measures :
  1. To evaluate response rate

Secondary Outcome Measures :
  1. To assess toxicity
  2. Overall survival
  3. Event-free survival
  4. Progression - free survival
  5. Disease - free survival
  6. Duration of response

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00491127

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
Sponsors and Collaborators
Eli Lilly and Company
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

Additional Information: Identifier: NCT00491127     History of Changes
Other Study ID Numbers: 6899
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: June 25, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents