Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

NCT ID: NCT02797717

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2027-12-31

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.

Conditions

Classical Hodgkins Lymphoma in Children and Adolescents.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A-"COPDAC-28"

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.

Group Type: OTHER

Radiotherapy:

Intervention Type: RADIATION

All patients will have 2 "OPEA"cycles(chemotherapy cycle:Vincristine,Etoposide,Prednisone,doxorubicin) ,After assignment ( by randomization) to one of the arms the patient will be treated accordingly . response assessment will be done after "OPEA" cycles (ERA) and after cycles of "copdac 28" or DECOPDAC 21(LRA).according to the assessments results patients will have radiotherapy or not.

Vincristine

Intervention Type: DRUG

ARM A and ARM B

Prednisone

Intervention Type: DRUG

ARM A and ARM B , 40mg/m2/day p.o

Dacarbazine

Intervention Type: DRUG

ARM A and ARM B , 250mg/m2 i.v

Cyclophosphamide

Intervention Type: DRUG

ARM A and ARM B , 625mg/m2 i.v

B- "DECOPDAC-21"

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

Group Type: EXPERIMENTAL

Radiotherapy:

Intervention Type: RADIATION

All patients will have 2 "OPEA"cycles(chemotherapy cycle:Vincristine,Etoposide,Prednisone,doxorubicin) ,After assignment ( by randomization) to one of the arms the patient will be treated accordingly . response assessment will be done after "OPEA" cycles (ERA) and after cycles of "copdac 28" or DECOPDAC 21(LRA).according to the assessments results patients will have radiotherapy or not.

Vincristine

Intervention Type: DRUG

ARM A and ARM B

Etoposide

Intervention Type: DRUG

ARM B , 100mg/m2/day

Prednisone

Intervention Type: DRUG

ARM A and ARM B , 40mg/m2/day p.o

Doxorubicin

Intervention Type: DRUG

ARM B , 25mg/m2

Dacarbazine

Intervention Type: DRUG

ARM A and ARM B , 250mg/m2 i.v

Cyclophosphamide

Intervention Type: DRUG

ARM A and ARM B , 625mg/m2 i.v

Interventions

Radiotherapy:

All patients will have 2 "OPEA"cycles(chemotherapy cycle:Vincristine,Etoposide,Prednisone,doxorubicin) ,After assignment ( by randomization) to one of the arms the patient will be treated accordingly . response assessment will be done after "OPEA" cycles (ERA) and after cycles of "copdac 28" or DECOPDAC 21(LRA).according to the assessments results patients will have radiotherapy or not.

Intervention Type: RADIATION

Vincristine

ARM A and ARM B

Intervention Type: DRUG

Etoposide

ARM B , 100mg/m2/day

Intervention Type: DRUG

Prednisone

ARM A and ARM B , 40mg/m2/day p.o

Intervention Type: DRUG

Doxorubicin

ARM B , 25mg/m2

Intervention Type: DRUG

Dacarbazine

ARM A and ARM B , 250mg/m2 i.v

Intervention Type: DRUG

Cyclophosphamide

ARM A and ARM B , 625mg/m2 i.v

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Giessen

OTHER

Sponsor Role: collaborator

GALIA AVRAHAMI

OTHER

Sponsor Role: lead

Responsible Party

GALIA AVRAHAMI

Senior pediatric oncologist physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dieter K.rholz, Prof. Dr.

Role: STUDY_CHAIR

Universit.tsklinikum Giessen

Galia Avrahami, MD

Role: PRINCIPAL_INVESTIGATOR

Schneider children medical center,Kaplan 14 Petach-Tikva,Israel

Locations

Schneider children's medical center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Galia Avrahami, MD

Role: CONTACT

Galia2@clalit.org.il

972-3-9253356

Michal Rada

Role: CONTACT

michalra6@clalit.org.il

972-524-643166

Facility Contacts

Galia Avrahami, MD

Role: primary

Galia2@clalit.org.il

972-3-9253356

Other Identifiers

scmci160509ctil

Identifier Type: -

Identifier Source: org_study_id