EUCTR2009-009431-30-ITActive, not recruitingNot Applicable
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
FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI0 sites336 target enrollmentStarted: March 31, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 336
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 < 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
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
Investigators
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