LIMITED-STAGE (STAGE I-IIA WITH NO AREAS OF BULK) HODGKIN?S LYMPHOMA. MedDRA version: 9.1 Level: SOC Classification code 10005329
Conditions
Interventions
Trade Name: ADRIBLASTINA
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Doxorubicin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: History of histologically confirmed classical Hodgkin lymphoma (cHL) Limited-stage disease defined as stage I or IIA with no areas of bulky disease Measurable disease Age >=18 years Adequate bone marrow reserve (ANC >= 1,500/uL, Platelet > 100,000/uL) LVEF >= 50% by MUGA scan or echocardiogram Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Lymphocyte predominant HL Prior chemotherapy or radiation therapy Severe pulmonary disease as judged by the PI including COPD and asthma Presence of CNS lymphoma Concomitant malignancies or previous malignancies (exception made for adequately treated basal or squamous cell carcinoma of the skin) Active infection requiring treatment with intravenous therapy Known HIV infection Active hepatitis B or C Pregnancy or lactation and women of child bearing age who are not practicing adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of ABVD chemotherapy supplemented with rituximab (R-ABVD) vs ABVD followed by limited-dose radiotherapy on the initially involved nodal sites (ABVD-> IF-RT ), in terms of failure-free survival (FFS) at 3 years. Failure is defined as disease progression during treatment, achievement of less than complete remission, relapse during follow-up or death from any cause;Secondary Objective: To compare 3-year event-free survival (EFS) of the two treatment arms. Events are defined as disease progression during treatment, less then CR, relapse, death from any cause or late serious treatment-related events. A serious treatment-related event is defined as III-IV cardiac toxicity (according to NYHA Functional Classification), grade III-IV pulmonary toxicity (according to CTCAE-NCI criteria), second cancers (including myelodisplastic syndromes, but excluding basal cell carcinoma and in situ cervical carcinoma). To compare the efficacy of the two treatment arms in terms of overall survival (OS), from randomization to any cause of death. To compare acute and late toxicities of any grade in the two treatment arms, including evaluation of cardiac toxic effects, bleomycin or radiation pneumonitis, pulmonary dysfunction, second cancers of any type and histology and gonadal toxicity.;Primary end point(s): To evaluate the failure-free survival (FFS) | — |
Countries
Italy
Outcome results
None listed