Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate response rate

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Spain: Ethics Committee

Study ID:

6899

NCT ID:

NCT00491127

Start Date:

April 2003

Completion Date:

June 2004

Related Keywords:

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

Name

Location