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

June 13, 2016 updated by: GALIA AVRAHAMI

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petach-Tikva, Israel, 4920235
        • Recruiting
        • Schneider Children's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Radiation: 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.
Drug: Vincristine
ARM A and ARM B
Drug: Prednisone
ARM A and ARM B , 40mg/m2/day p.o
Drug: Dacarbazine
ARM A and ARM B , 250mg/m2 i.v
Drug: Cyclophosphamide
ARM A and ARM B , 625mg/m2 i.v
Experimental: 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
Radiation: 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.
Drug: Vincristine
ARM A and ARM B
Drug: Prednisone
ARM A and ARM B , 40mg/m2/day p.o
Drug: Dacarbazine
ARM A and ARM B , 250mg/m2 i.v
Drug: Cyclophosphamide
ARM A and ARM B , 625mg/m2 i.v
Drug: Etoposide
ARM B , 100mg/m2/day
Drug: Doxorubicin
ARM B , 25mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase event free survival rate from 88% to 93%
Time Frame: 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.
Will be assessed once a year up to 5 years after end of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of haematotoxicity between arm A and arm B
Time Frame: 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.
Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GALIA AVRAHAMI

Collaborators

University of Giessen

Investigators

  • Study Chair: Dieter K.rholz, Prof. Dr., Universit.tsklinikum Giessen
  • Principal Investigator: Galia Avrahami, MD, Schneider children medical center,Kaplan 14 Petach-Tikva,Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • scmci160509ctil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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