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

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ClinicalTrials.gov Identifier: NCT02797717
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : June 14, 2016
Sponsor:
Collaborator:
University of Giessen
Information provided by (Responsible Party):
GALIA AVRAHAMI, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Classical Hodgkins Lymphoma in Children and Adolescents. Radiation: Radiotherapy: Drug: Vincristine Drug: Etoposide Drug: Prednisone Drug: Doxorubicin Drug: Dacarbazine Drug: Cyclophosphamide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: Etoposide
ARM B , 100mg/m2/day

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

Drug: Doxorubicin
ARM B , 25mg/m2

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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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: (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797717


Contacts
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Contact: Galia Avrahami, MD 972-3-9253356 Galia2@clalit.org.il
Contact: Michal Rada 972-524-643166 michalra6@clalit.org.il

Locations
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Israel
Schneider children's medical center Recruiting
Petach-Tikva, Israel, 4920235
Contact: Galia Avrahami, MD    972-3-9253356    Galia2@clalit.org.il   
Sponsors and Collaborators
GALIA AVRAHAMI
University of Giessen
Investigators
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Study Chair: Dieter K.rholz, Prof. Dr. Universit.tsklinikum Giessen
Principal Investigator: Galia Avrahami, MD Schneider children medical center,Kaplan 14 Petach-Tikva,Israel

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Responsible Party: GALIA AVRAHAMI, Senior pediatric oncologist physician, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02797717     History of Changes
Other Study ID Numbers: scmci160509ctil
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Etoposide
Etoposide phosphate
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids