PHASE III STUDY COMPARING RITUXIMAB-SUPPLEMENTED ABVD (R-ABVD) WITH ABVD FOLLOWED BY INVOLVED-FIELD RADIOTHERAPY (ABVD-RT) IN LIMITED-STAGE (STAGE I-IIA WITH NO AREAS OF BULK) HODGKIN?S LYMPHOMA. - ND
- Conditions
- IMITED-STAGE (STAGE I-IIA WITH NO AREAS OF BULK) HODGKIN?S LYMPHOMA.MedDRA version: 9.1Level: SOCClassification code 10005329
- Registration Number
- EUCTR2009-009431-30-IT
- Lead Sponsor
- FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 336
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 < 2 mg/dl, serum bilirubin < 2 mg/dl, AST or ALT <2x ULN
Bi-dimensionally measurable disease
Use of effective means of contraception
Signed informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method