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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491127
• Other study ID #: 6899
• Secondary ID: B9E-XM-S315
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2007
• Last updated: June 21, 2007
• Start date: April 2003
• Est. completion date: June 2004

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• gemcitabine

• cisplatin

• dexamethasone

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate response rate
Secondary	To assess toxicity
Secondary	Overall survival
Secondary	Event-free survival
Secondary	Progression - free survival
Secondary	Disease - free survival
Secondary	Duration of response

External Links

•   Lilly Clinical Trial Registry