Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

Not Applicable

Recruiting

• Conditions: Classical Hodgkins Lymphoma in Children and Adolescents.
• Interventions: Drug: Vincristine; Drug: Prednisone; Drug: Etoposide; Drug: Dacarbazine; Drug: Cyclophosphamide; Drug: Doxorubicin

• Registration Number: NCT02797717
• Lead Sponsor: GALIA AVRAHAMI

Brief Summary

Reduction of the indication for radiotherapy (RT) in newly diagnosed patients with classical Hodgkins lymphoma without compromising cure rates. Investigation of a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkins lymphoma patients to compensate for reduction in RT.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-12
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Last Update Submitted: 2016-06-13
• Last Update Posted: 2016-06-14
• Primary Completion: 2022-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

1. histologically confirmed primary diagnosis of classical Hodgkin's lymphoma.
2. patients under 18 years of age on the date of written informed consent. In specialized Teenage and Young Adult (TYA) units in Australia, France, Italy, New Zealand and United Kingdom patients up to 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.
3. written informed consent of the patient and/or the patient's parents or guardian according to national laws.
4. negative pregnancy test within 2 weeks prior to starting treatment for female patients with childbearing potential

Exclusion Criteria

(Patients with one or more of the following criterion are excluded)

1. prior chemotherapy or radiotherapy for other malignancies
2. 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).
3. diagnosis of lymphocyte-predominant Hodgkin's lymphoma
4. other (simultaneous) malignancies
5. contraindication or known hypersensitivity to study drugs
6. severe concomitant diseases (e.g. immune deficiency syndrome)
7. known HIV-positivity
8. residence outside the participating countries where long term follow-up cannot be guaranteed
9. pregnancy and / or lactation
10. patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment
11. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-"COPDAC-28"	Cyclophosphamide	standard COPDAC-28 (chemotherapy cycle:Cyclophosphamide,Doxorubicin,Prednisone,Dacarbazine), chemotherapy and standard involved node radiotherapy. drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15. Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3. Vincristine 15mg/m2 , I.V. , day1+day 8. Cyclophosphamide 500mg/m2,infusion,day 1+day 8.
A-"COPDAC-28"	Vincristine	standard COPDAC-28 (chemotherapy cycle:Cyclophosphamide,Doxorubicin,Prednisone,Dacarbazine), chemotherapy and standard involved node radiotherapy. drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15. Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3. Vincristine 15mg/m2 , I.V. , day1+day 8. Cyclophosphamide 500mg/m2,infusion,day 1+day 8.
A-"COPDAC-28"	Prednisone	standard COPDAC-28 (chemotherapy cycle:Cyclophosphamide,Doxorubicin,Prednisone,Dacarbazine), chemotherapy and standard involved node radiotherapy. drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15. Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3. Vincristine 15mg/m2 , I.V. , day1+day 8. Cyclophosphamide 500mg/m2,infusion,day 1+day 8.
A-"COPDAC-28"	Dacarbazine	standard COPDAC-28 (chemotherapy cycle:Cyclophosphamide,Doxorubicin,Prednisone,Dacarbazine), chemotherapy and standard involved node radiotherapy. drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15. Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3. Vincristine 15mg/m2 , I.V. , day1+day 8. Cyclophosphamide 500mg/m2,infusion,day 1+day 8.
B- "DECOPDAC-21"	Vincristine	DECOPDAC-21(chemotherapy cycle:Dacarbazine,Etoposide,Doxorubicin,Cyclophosphamide,Prednisone,Vincristine) intensified chemotherapy and no RT or restricted fields of radiotherapy. Drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15: Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3 Vincristine 15mg/m2 , I.V. , day1+day 8 Cyclophosphamide 625mg/m2,infusion,day1+day2 Etoposide 100mg/m2/day,infusion,day 1- day 3 Doxorubicin 25mg/m2, infusion, day 1
B- "DECOPDAC-21"	Prednisone	DECOPDAC-21(chemotherapy cycle:Dacarbazine,Etoposide,Doxorubicin,Cyclophosphamide,Prednisone,Vincristine) intensified chemotherapy and no RT or restricted fields of radiotherapy. Drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15: Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3 Vincristine 15mg/m2 , I.V. , day1+day 8 Cyclophosphamide 625mg/m2,infusion,day1+day2 Etoposide 100mg/m2/day,infusion,day 1- day 3 Doxorubicin 25mg/m2, infusion, day 1
B- "DECOPDAC-21"	Etoposide	DECOPDAC-21(chemotherapy cycle:Dacarbazine,Etoposide,Doxorubicin,Cyclophosphamide,Prednisone,Vincristine) intensified chemotherapy and no RT or restricted fields of radiotherapy. Drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15: Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3 Vincristine 15mg/m2 , I.V. , day1+day 8 Cyclophosphamide 625mg/m2,infusion,day1+day2 Etoposide 100mg/m2/day,infusion,day 1- day 3 Doxorubicin 25mg/m2, infusion, day 1
B- "DECOPDAC-21"	Doxorubicin	DECOPDAC-21(chemotherapy cycle:Dacarbazine,Etoposide,Doxorubicin,Cyclophosphamide,Prednisone,Vincristine) intensified chemotherapy and no RT or restricted fields of radiotherapy. Drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15: Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3 Vincristine 15mg/m2 , I.V. , day1+day 8 Cyclophosphamide 625mg/m2,infusion,day1+day2 Etoposide 100mg/m2/day,infusion,day 1- day 3 Doxorubicin 25mg/m2, infusion, day 1
B- "DECOPDAC-21"	Dacarbazine	DECOPDAC-21(chemotherapy cycle:Dacarbazine,Etoposide,Doxorubicin,Cyclophosphamide,Prednisone,Vincristine) intensified chemotherapy and no RT or restricted fields of radiotherapy. Drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15: Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3 Vincristine 15mg/m2 , I.V. , day1+day 8 Cyclophosphamide 625mg/m2,infusion,day1+day2 Etoposide 100mg/m2/day,infusion,day 1- day 3 Doxorubicin 25mg/m2, infusion, day 1
B- "DECOPDAC-21"	Cyclophosphamide	DECOPDAC-21(chemotherapy cycle:Dacarbazine,Etoposide,Doxorubicin,Cyclophosphamide,Prednisone,Vincristine) intensified chemotherapy and no RT or restricted fields of radiotherapy. Drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15: Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3 Vincristine 15mg/m2 , I.V. , day1+day 8 Cyclophosphamide 625mg/m2,infusion,day1+day2 Etoposide 100mg/m2/day,infusion,day 1- day 3 Doxorubicin 25mg/m2, infusion, day 1

Primary Outcome Measures

Name	Time	Method
Increase event free survival rate from 88% to 93%	Will be assessed once a year up to 5 years after end of treatment.	Methods of measurement: chest X-ray; US neck, abdomen and pelvis; lung function; T4,Throid Stimulating Hormone ,US of thyroid; MRI of initially involved region; chest CT in patients with initial lung involvement.

Secondary Outcome Measures

Name	Time	Method
comparison of haematotoxicity between arm A and arm B	Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle	Evaluation of haematotoxicity by documentation of blood count courses during "OEPA", COPDAC-28 and DECOPDAC-21 cycles. Comparison between COPDAC-28 versus DECOPDAC-21.; For ERA(early response assessment) PET(Positron Emission Tomography)-positive patients to compare to the LRA (late response assessment)PET-positivity rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21.

Trial Locations

Locations (1)

Schneider children's medical center; 🇮🇱 Petach-Tikva, Israel