Cisplatin With Gemcitabine With Dexamethasone in Patients With Aggressive Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00491127
First received: June 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: gemcitabine Drug: cisplatin Drug: dexamethasone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Cisplatin
Gemcitabine
Gemcitabine hydrochloride
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491127
Locations
| 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, Spain | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00491127 History of Changes |
| Other Study ID Numbers: | 6899, B9E-XM-S315 |
| Study First Received: | June 21, 2007 |
| Last Updated: | June 21, 2007 |
| Health Authority: | Spain: Ethics Committee |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gemcitabine Cisplatin Dexamethasone Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Protease Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013