Hodgkin's Disease
Conditions
Keywords
Lymphoma, Gemcitabine, Advanced stages Hodgkin's lymphoma, Elderly
Brief summary
The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.
Detailed description
Gemcitabine shows promising activity in patients with relapsed lymphoma either administered as single agent or in combination with other cytotoxic agents. No trial to date evaluated its role in patients with primary Hodgkin's lymphoma. We therefore developed a three-weekly regimen based on the standard ABVD regimen.
Interventions
Sponsors
German Hodgkin's Lymphoma Study Group
Eli Lilly and Company
University of Cologne
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Hodgkin's lymphoma (histologically proven) * Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV * No prior antitumor therapy * Age 60 to 75 years * WHO performance status 0-2 * Normal pulmonary function * Written informed consent
Exclusion criteria
* The following histologies are excluded: lymphocyte predominant HD * Leukocytes \< 2,500/microL * Platelets \< 100,000/microL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Dose-limiting toxicities and dose reductions | — |
| Phase II: Treatment administration and complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicities | — |
| Supportive care (RBCT need, antibiotic need) | — |
| Early progression rate | — |
| Overall survival | — |
Countries
Germany
Outcome results
None listed