Previously untreated advanced stage Hodgkin lymphoma
Conditions
Interventions
After 2 cycles of ABVD for all patients, interim PET is performed. Interim PET-negative patients receive additional 4 cycles of ABVD (every 4 weeks)
doxorubicin 25mg/m2, div, day1and 15
bleomycin 9mg/m2 (max 15mg/body), div, day1 and 15
vinblastine 6mg/m2 (max 10mg/body), iv, day1 and 15
dacarbazine 375mg/m2, div, day1 and 15. Interim PET-positive patients receive 6 cycles of escalated BEACOPP (every 3 weeks)
bleomycin 10mg/m2 (max 15mg/body) div day8
etoposide 200mg/m2 div day1-3
doxorubicin 35mg/m2 div day1
cyclophosphamide 1250mg/m2 div day1
vincristine 1.4mg/m2 (max 2mg/body) iv day8
procarbazine 100mg/m2 po day1-7
prednisolone 40mg/m2 po day1-14
G-CSF sc day4-.
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed as classical Hodgkin lymphoma according to WHO classification 2008. 2) Clinical stage III or IV, or clinical stage IIB with bulky mediastinal lesion or continuously invasive lesion to extranodal tissues. 3) No central nervous system involvement 4) Aged 20 to 60 years old at enrollment 5) ECOG Performance status: 0-2 6) Having measuralble lesion (fulfill the 3 following criteria) (1) lymph node or extranodal disease diagnosed as Hodgkin lymphoma by imaging, histopathological or cytopathological method. (2) measurable lesion by CT scan (transverse imaging with bidimensional measurements) (3) longest transverse diameter for lesions of 1.5 cm or more. 7) No previous anti-cancer treatment (chemotherapy and/or radiation) except for hormone therapy 8) Meet all of the following: (1) absolute neutrophil count: no less than 1,000/mm3 (2) platelet count: no less than 100,000/mm3 (3) total bilirubin: 2.0 mg/dL or below (4) AST(GOT) : no more than 150 U/L (5) ALT(GPT) : no more than 150 U/L (6) serum creatinine: 1.6 mg/dL or below (male), 1.2 mg/dL or below (female) (7) fasting blood glucose: 150 mg/dL or below (8) PaO2 (room air): at least 70 torr 9) ECG: neither ischemic change nor arrhythmia requiring medical intervention 10) Cardiac ejection fraction: at least 50% 11) Written informed consent by the patient
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous malignancy 2) Active infection requiring systemic treatment 3) Pregnant or nursing women 4) Psychiatric disease 5) Continuous systemic treatment with steroids or other immunosuppressive drugs 6) Insulin-dependent or uncontrollable diabetes mellitus 7) Unstable angina pectoris, or history of myocardial infarction within six months 8) Seropositive for HBsAg or anti-HCV antibody 9) Seropositive for anti-HIV antibody or unexamined 10) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema on chest CT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progressin-free survival among all eligible patients and among inteim PET-positive patients (Co-primary endpoints) | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, event-free survival, complete response rate, incidence of adverse events, incidence of severe adverse events, incidence of secondary malignancy, incidence of per-protocol in terms of interim PET | — |
Countries
Japan
Contacts
Public ContactShigeru Kusumoto
JCOG1305 Coordinating Office Division of Hematology and Oncology, Nagoya City University Hospital
Outcome results
None listed