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Treatment for Classical Hodgkin Lymphoma in Children and Adolescents (EuroNet-PHL-C2)

Primary Purpose

Classical Hodgkins Lymphoma in Children and Adolescents.

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Radiotherapy:
Vincristine
Etoposide
Prednisone
Doxorubicin
Dacarbazine
Cyclophosphamide
Sponsored by
GALIA AVRAHAMI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Classical Hodgkins Lymphoma in Children and Adolescents.

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schneider children's medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

A-"COPDAC-28"

B- "DECOPDAC-21"

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Increase event free survival rate from 88% to 93%
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

comparison of haematotoxicity between arm A and arm B
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.

Full Information

First Posted
April 12, 2016
Last Updated
June 13, 2016
Sponsor
GALIA AVRAHAMI
Collaborators
University of Giessen
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1. Study Identification

Unique Protocol Identification Number
NCT02797717
Brief Title
Treatment for Classical Hodgkin Lymphoma in Children and Adolescents
Acronym
EuroNet-PHL-C2
Official Title
An International, Multicentre, Randomised Controlled Trial. Treatment for Classical Hodgkin Lymphoma in Children and Adolescents Standard Treatment (Chemotherapy and RT) Compared With Experimental Treatment (Chemotherapy Without RT or Restricted to RT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
GALIA AVRAHAMI
Collaborators
University of Giessen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Classical Hodgkins Lymphoma in Children and Adolescents.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A-"COPDAC-28"
Arm Type
Other
Arm Description
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.
Arm Title
B- "DECOPDAC-21"
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy:
Intervention Description
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
Drug
Intervention Name(s)
Vincristine
Intervention Description
ARM A and ARM B
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
ARM B , 100mg/m2/day
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
ARM A and ARM B , 40mg/m2/day p.o
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
ARM B , 25mg/m2
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Description
ARM A and ARM B , 250mg/m2 i.v
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
ARM A and ARM B , 625mg/m2 i.v
Primary Outcome Measure Information:
Title
Increase event free survival rate from 88% to 93%
Description
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.
Time Frame
Will be assessed once a year up to 5 years after end of treatment.
Secondary Outcome Measure Information:
Title
comparison of haematotoxicity between arm A and arm B
Description
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.
Time Frame
Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically confirmed primary diagnosis of classical Hodgkin's lymphoma. 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. 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 Criteria: (Patients with one or more of the following criterion are excluded) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Galia Avrahami, MD
Phone
972-3-9253356
Email
Galia2@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Rada
Phone
972-524-643166
Email
michalra6@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter K.rholz, Prof. Dr.
Organizational Affiliation
Universit.tsklinikum Giessen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Galia Avrahami, MD
Organizational Affiliation
Schneider children medical center,Kaplan 14 Petach-Tikva,Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider children's medical center
City
Petach-Tikva
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galia Avrahami, MD
Phone
972-3-9253356
Email
Galia2@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

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