Hodgkin’s lymphoma MedDRA version: 8.1 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214928
Pharmaceutical Form:
INN or Proposed INN: BLEOMYCIN
CAS Number: 11056067
Pharmaceutical Form:
INN or Proposed INN: VINBL
Sponsors
Euopean Organisation of Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven Hodgkin’s lymphoma, except for the nodular lymphocyte predominant subtype (nodular paragranuloma) - Supradiaphragmatic Ann Arbor clinical stage I or II, both favorable and unfavorable prognostic subsets (for definition of favorable (F) and unfavorable (U), see at the end of this section) - Previously untreated - Age 15 through 70 years - FDG-PET scan already prospectively planned after two cycles of ABVD for all patients (see Appendix G). - WHO performance status grades 0, 1, 2 or 3 (see Appendix B) during the whole duration of study treatment. - Absence of severe cardiac, pulmonary, neurologic psychiatric or metabolic disease. Patients with unstable diabetes mellitus are excluded (to avoid uninterpretable FDG-PET scan). - Adequate liver and renal function (total serum bilirubin = 2.5 x ULN, serum creatinine = 2.5 x ULN) - No concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for >5 years - No known HIV infection Are the trial subjects under 18? yes 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:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether chemotherapy alone is as effective, but less toxic, as combined modality treatment, in patients with stage I/II Hodgkin’s lymphoma who are FDG-PET scan negative after two cycles of ABVD. This question will be addressed in the group of patients with favorable stages I/II disease (F) as well as in those with unfavorable stage I/II disease (U).;Secondary Objective: To evaluate whether chemotherapy with escalated BEACOPP improves the outcome of PET positive patients – after 2 cycles of chemotherapy - when compared with standard therapy;Primary end point(s): progression-free survival (PFS). PFS is defined as time interval form the date of randomization until documentation of first progression or death whichever comes first | — |
Countries
Belgium, Denmark, France, Italy, Netherlands
Outcome results
None listed