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Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

NCT02797717 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2200

Last updated 2016-06-14

No results posted yet for this study

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.

Interventions

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

Sponsors & Collaborators

  • University of Giessen

    collaborator OTHER

  • GALIA AVRAHAMI

    lead OTHER

Principal Investigators

  • Dieter K.rholz, Prof. Dr. · Universit.tsklinikum Giessen

  • Galia Avrahami, MD · Schneider children medical center,Kaplan 14 Petach-Tikva,Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2022-12-31
Completion
2027-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02797717 on ClinicalTrials.gov