drugset / Trial / NCT00992030

R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma

NCT00992030 ↗

Phase 3 Terminated 112 enrolled Fondazione Michelangelo
RandomizedParallel-groupOpen-labelTreatment

Summary

Combined modality therapy has then emerged as the standard of care for limited-stage Hodgkin's lymphoma and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy that is devoid of alkylating agents and associated with a low potential for gonadal toxicity and leukemogenesis, is currently considered a gold standard. Nevertheless, the disadvantage to combine radiotherapy to ABVD is represented by late cardiovascular events (myocardial dysfunction and coronary or valvular disease), especially when the heart is within the radiation field; bleomycin pulmonary toxicity also is increased in conjunction with RT and secondary tumors, in particular in the RT fields. This study aims at treating patients with limited disease with multiagent chemotherapy alone, without irradiation, and using radiotherapy only for relapses.

Timeline

Start
2009-09
Primary completion
2019-03
Completion
2019-03

Outcome

Outcome not reported

Stopped (Enrollment): “Low recruitment and difficulty in having study data”

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications