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CompletedNCT00491127Updated Jun 25, 2007

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

A Phase 2 interventional study of gemcitabine and cisplatin in Non-Hodgkin's Lymphoma, sponsored by Eli Lilly and Company. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-06-25.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Hodgkin's Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 10 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Interventions

  • Druggemcitabine
  • Drugcisplatin
  • Drugdexamethasone
06

What researchers measure

Primary outcomes

  1. To evaluate response rate

Secondary outcomes

  1. To assess toxicity

  2. Overall survival

  3. Event-free survival

  4. Progression - free survival

  5. Disease - free survival

  6. Duration of response

07

Study locations

1 site
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00491127
Lead sponsor
Eli Lilly and Company
First posted
Jun 25, 2007
Start date
Apr 2003
Completion
Jun 2004
Last update
Jun 25, 2007

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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