European Network-Paediatric Hodgkin Lymphoma Study Group: Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
EuroNet-PHL-C2: international, multicentre, randomised controlled trial for the first line treatment of classical Hodgkin`s Lymphoma in children and adolescents to individualise treatment (risk stratified chemotherapy and response adapted radiotherapy) and decrease long-term complications.
Justus Liebig University of Giessen
160 participants
Mar 23, 2015
Interventional
Conditions
Summary
This aim of this international, multicentre trial is to evaluate the safety and efficacy of a comprehensive first line treatment strategy for paediatric and adolescent patients with Classical Hodgkin Lymphoma (cHL). Who is it for? You may be eligible to join this study if you are aged less than 25 years and have a histologically confirmed primary diagnosis of classical Hodgkin’s lymphoma (cHL). Study details Based on risk factors at diagnosis, patient will be considered either low risk (TL-1), intermediate risk (TL-2) or advanced risk (TL-3) cHL. All patients initially receive 2 x 28 day cycles of the chemotherapy combination OEPA (Prednisone/Prednisolone, Vincristine, Doxorubicin and Etoposide/Etopophos). The response to OEPA treatment is measured using FDG-PET imaging and the next phase of treatment is determined. Treatment may include chemotherapy combinations called COPDAC-28 (consists of Prednisone/Prednisolone, Dacarbazine, Vincristine and Cyclophosphamide in a 28 day cycle) or DECOPDAC-21 (consists of Prednisone/Prednisolone, Dacarbazine, Vincristine and Cyclophosphamide, Etoposide/Etopophos and Doxorubicin in a 21 day cycle). Depending on risk level and response to treatment, patients may also be treated with Radiation Therapy. Patients in TL-2 and TL-3 will be randomly allocated to receive either the standard chemotherapy arm (COPDAC-28) or the experimental intensified chemotherapy arm (DECOPDAC-21). Patient response to therapy will be monitored using imaging and clinical exams for 5 years following completion of treatment. It is hoped that this study will maintain or improve survival while decreasing long term complications.
Eligibility
Inclusion Criteria4
- Histologically confirmed primary diagnosis of classical Hodgkin’s lymphoma
- Patients under 18 years of age on the date of written informed consent (In specialised Teenage and Young Adult units in Australia, France, Italy, New Zealand and UK patients under 25 years of age can also be enrolled.). Lower age limits will be country specific according to national laws or formal insurance requirements that may preclude very young patients.
- Written informed consent of the patient and/or the patient’s parents or guardian according to national laws
- Negative pregnancy test within 2 weeks prior to starting treatment for female patients with childbearing potential.
Exclusion Criteria11
- Prior chemotherapy or radiotherapy for other malignancies
- Pre-treatment of Hodgkin’s lymphoma (except for steroid pre-phase to a maximum of 7-10 days for emergency treatment of a large mediastinal tumour)
- Diagnosis of lymphocyte-predominant Hodgkin’s lymphoma
- Other (simultaneous) malignancies
- Contraindication or known hypersensitivity to study drugs
- Severe concomitant diseases (e.g. immune deficiency syndrome)
- Known HIV-positivity
- Residence outside the participating countries where long term follow-up cannot be guaranteed
- Pregnancy and/or lactation
- Patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment
- Current or recent (within 30 days prior to date of written informed consent) treatment with another investigational drug or participation in another interventional clinical trial
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients are assigned to treatment levels (TL) according to stage, tumour size and blood ESR values. Group 1: Treatment level 1 2 x 28 day cycles of OEPA chemotherapy (OEPA: Prednisone/Prednisolone: 60 mg/m2/day orally, on days 1-15 + Vincristine: 1.5 mg/m2 i.v., on day 1, 8 and 15 + Doxorubicin: 40 mg/m2 i.v., day 1 and 15 + Etoposide/Etopophos: 125 mg/m2 Etoposide; i.v., day 1 – 5) Patients with an adequate response via PET scan (ie. PET Deauville Score of 1, 2 or 3), receive 1 x 28 day cycle of COPDAC28 (COPDAC28 = Prednisone/Prednisolone: 40 mg/m2/day orally, on days 1-15 + Dacarbazine 250 mg/m2 i.v., day 1 – 3 + Vincristine: 1.5 mg/m2 i.v., on day 1 and 8 + Cyclophosphamide 500 mg/m2, i.v., day 1 + 8), beginning 1-2 weeks post OEPA. Patients with an inadequate response via PET scan (ie. PET Deauville Score of 4 or 5) will receive involved node radiotherapy to all initially involved sites (19.8 Gy in 11 fractions given at 1 fraction daily for 5 days per week (1.8 Gy per fraction)) at 2-4 weeks post OEPA. There is no randomisation in TL-1. Group 2: Treatment Level 2 and 3 with an adequate early PET Response All patients receive 2 cycles of OEPA (as above). Patients with an adequate response via PET scan undergo randomisation between COPDAC28 (standard therapy, as above) or DECOPDAC21 (experimental: 21 day cycles of Prednisone/Prednisolone 40 mg/m2/day, orally on days 1 – 8 + Dacarbazine 250 mg/m2 i.v., day 1 – 3 + Vincristine: 1.5 mg/m2 i.v., on day 1 and 8 + Cyclophosphamide 625 mg/m2, i.v., day 1 and 2 + Etoposide/Etopophos 100 mg/m2/day i.v. on day 1-3 + Doxorubicin 25 mg/m2 i.v. on day 1). Patients in TL2 receive 2 cycles of COPDAC28 or DECOPDAC21 and patients in TL3 receive 4 cycles of COPDAC28 or DECOPDAC21. Patients do not receive radiotherapy. Group 3: Treatment Level 2 and 3 with an inadequate Early PET Response All patients receive 2 cycles of OEPA (as above). Patients with an inadequate response via PET scan undergo randomisation between COPDAC28 (standard therapy) or DECOPDAC21 (experimental), as above. Patients in TL2 receive 2 cycles of COPDAC28 or DECOPDAC21 and patients in TL3 receive 4 cycles of COPDAC28 or DECOPDAC21. Patients receiving COPDAC28 are followed with standard involved node radiotherapy to all initially involved sites (19.8 Gy in 11 fractions (1.8 Gy per fraction), and a boost (10 Gy in 5 fractions (2 Gy per fraction)) to late response assessment (LRA) FDG-PET positive residuals. Patients who receive the intensified DECOPDAC21 chemotherapy will also receive radiotherapy to LRA FDG-PET positive sites only (28.8 Gy in 16 fractions given at 1 fraction daily for 5 days per week (1.8 Gy per fraction). Intravenous drugs will be administered in hospital. Participants and their families will be asked to complete a medication diary to record oral medication usage.
Locations(30)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12618000069257