Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma

University of Cologne60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin's Disease

Interventions

PrednisoneDRUG

VinblastineDRUG

Doxorubicin (Adriamycin)DRUG

GemcitabineDRUG

Eligibility

Sex: ALLMin age: 60 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cologne

Cologne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Phase I: Dose-limiting toxicities and dose reductions

Phase II: Treatment administration and complete response rate

Secondary Outcomes

Toxicities

Supportive care (RBCT need, antibiotic need)

Early progression rate

Overall survival

Data from ClinicalTrials.gov

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