HODGKIN LYMPHOMA MedDRA version: 9.1 Level: LLT Classification code 10020205 Term: Hodgins
Conditions
Interventions
Trade Name: DOXORUBICINA BAXTER*EV 20FL50M
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Doxorubicin
Concentration unit: gm/m2 gram(s)/square meter
Concentration type
Sponsors
IIL INTERGRUPPO ITALIANO LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of Hodgkin?s lymphoma, with the exclusion of nodular lymphocyte predominance. - Age 18-70. - Stage IIB-IV. - No prior therapy. - ECOG performance status grades 0-3 (see Appendix 4) - FDG-PET scan performed before treatment. - Written Informed Consent. 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
Exclusion criteria: - Age less than 18 or more than 70. - Prior therapy for Hodgkin?s lymphoma. - Other concomitant or prior malignancies, with the exception of basal cell skin carcinoma, of adequately treated carcinoma in situ of the cervix and of any cancer in complete remission for more than 5 years. - Pregnancy or breast-feeding. - Clinically significant cardiac disease, including congestive heart failure, that can contraindicate the treatment with anthracyclines (NYHA class ≥ 2 or FEV < 45%). - HIV infection. - Any other contraindication to ABVD, such as renal failure (creatinine level more than two times the normal value) or hepatic failure (AST/ALT or bilirubine more than 2.5 times the normal value). - Concomitant participation to a study in which investigational drugs are tested. - Absence of a written Informed Consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if patients considered a failure of the initial treatment, for residual PET positivity after the first two courses of ABVD (PET-2 positive), can be salvaged with an early shift to high-dose chemotherapy supported by stem cell rescue.;Secondary Objective: To analyse if patients entering an early complete response (PET-2 negative), can be spared subsequent radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. In order to answer this question, PET-2 negative patients are randomized between radiotherapy on initial bulky disease areas versus no radiotherapy.;Primary end point(s): 2 year event free survival (EFS) rate. Events are considered the disease progression, the late serious treatment-related events, secondary cancers, and deaths from any cause. | — |
Countries
Italy
Outcome results
None listed