Classical Hodgkins Lymphoma in Children and Adolescents.EuroNet-PHL-C2NCT02797717
Treatment for Classical Hodgkin Lymphoma in Children and Adolescents
A study testing Radiotherapy:, Vincristine and Etoposide in people with Classical Hodgkins Lymphoma in Children and Adolescents., run by GALIA AVRAHAMI at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Classical Hodgkins Lymphoma in Children and Adolescents.
- What is being tested?
- Radiotherapy:, Vincristine and Etoposide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2015to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Schneider children's medical center
Petah Tikva, 4920235
Galia Avrahami, MD, 972-3-9253356, Galia2@clalit.org.il
About this study
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)
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.
- Being tested
- Radiotherapy:, Vincristine, Etoposide, Prednisone, Doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy: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.
VincristineDrug
ARM A and ARM B
EtoposideDrug
ARM B , 100mg/m2/day
PrednisoneDrug
ARM A and ARM B , 40mg/m2/day p.o
DoxorubicinDrug
ARM B , 25mg/m2
DacarbazineDrug
ARM A and ARM B , 250mg/m2 i.v
CyclophosphamideDrug
ARM A and ARM B , 625mg/m2 i.v
| Study group | Role | What they receive |
|---|---|---|
| A-"COPDAC-28" | Other | 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. Receives: Radiation: Radiotherapy:; Drug: Vincristine; Drug: Prednisone; Drug: Dacarbazine; Drug: Cyclophosphamide |
| B- "DECOPDAC-21" | Experimental | 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 Receives: Radiation: Radiotherapy:; Drug: Vincristine; Drug: Etoposide; Drug: Prednisone; Drug: Doxorubicin; Drug: Dacarbazine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Will be assessed once a year up to 5 years after end of treatment.
Secondary outcomes (1)
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.
Measured: Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkins Lymphoma in Children and Adolescents.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GALIA AVRAHAMI
- Sponsor type
- University, hospital or other
- Collaborators
- University of Giessen
- Responsible party
- Sponsor-investigator, GALIA AVRAHAMI, Rabin Medical Center
- Investigators
- Dieter K.rholz, Prof. Dr., Study chair, Universit.tsklinikum GiessenGalia Avrahami, MD, Principal investigator, Schneider children medical center,Kaplan 14 Petach-Tikva,Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797717
- Sponsor's protocol ID
- scmci160509ctil
- Acronym
- EuroNet-PHL-C2
- Status last verified
- Jun 2016
- First submitted
- 12 Apr 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02797717
- Acronym / sponsor ID
- EuroNet-PHL-C2 / scmci160509ctil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- GALIA AVRAHAMIUniversity, hospital or other
- Collaborators
- University of Giessen
- Study start
- Nov 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-"COPDAC-28" | Other | Radiation: Radiotherapy:, Drug: Vincristine, Drug: Prednisone, Drug: Dacarbazine, Drug: Cyclophosphamidestandard 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. |
| B- "DECOPDAC-21" | Experimental | Radiation: Radiotherapy:, Drug: Vincristine, Drug: Etoposide, Drug: Prednisone, Drug: Doxorubicin, Drug: Dacarbazine, Drug: CyclophosphamideDECOPDAC-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 |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | A-"COPDAC-28", B- "DECOPDAC-21" |
| VincristineARM A and ARM B | Drug | A-"COPDAC-28", B- "DECOPDAC-21" |
| EtoposideARM B , 100mg/m2/day | Drug | B- "DECOPDAC-21" |
| PrednisoneARM A and ARM B , 40mg/m2/day p.o | Drug | A-"COPDAC-28", B- "DECOPDAC-21" |
| DoxorubicinARM B , 25mg/m2 | Drug | B- "DECOPDAC-21" |
| DacarbazineARM A and ARM B , 250mg/m2 i.v | Drug | A-"COPDAC-28", B- "DECOPDAC-21" |
| CyclophosphamideARM A and ARM B , 625mg/m2 i.v | Drug | A-"COPDAC-28", B- "DECOPDAC-21" |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dieter K.rholz, Prof. Dr. study chair
Universit.tsklinikum Giessen
Galia Avrahami, MD principal investigator
Schneider children medical center,Kaplan 14 Petach-Tikva,Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy:, Vincristine and Etoposide in people with Classical Hodgkins Lymphoma in Children and Adolescents., run by GALIA AVRAHAMI at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galia Avrahami, MD (972-3-9253356, Galia2@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.