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
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2003
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 21, 2007
CompletedFirst Posted
Study publicly available on registry
June 25, 2007
CompletedJune 25, 2007
June 1, 2007
June 21, 2007
June 21, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate response rate
Secondary Outcomes (6)
To assess toxicity
Overall survival
Event-free survival
Progression - free survival
Disease - free survival
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 21, 2007
First Posted
June 25, 2007
Study Start
April 1, 2003
Study Completion
June 1, 2004
Last Updated
June 25, 2007
Record last verified: 2007-06