Hodgkin lymphoma in children and adolescents
Conditions
Interventions
Trade Name: Vincristin "Pfizer" CS 2 mg
Product Name: Vincristine
Product Code: VCR
Pharmaceutical Form: Solution for injection
INN or Proposed INN: VINCRISTINE
CAS Number: 57-22-7
Current Sponsor cod
Sponsors
Justus Liebig University of Giessen
Eligibility
Sex/Gender
All
Inclusion 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 France, Italy and UK 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 Are the trial subjects under 18? yes Number of subjects for this age range: 2200 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • prior chemotherapy or radiotherapy for other malignancies • pre-treatment of Hodgkin’s lymphoma (except for 7-10 days steroid pre-phase 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 year 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 3.4.1.1Randomised 1.To increase event-free survival in ERA(early response assessment) PET-negative intermediate and advanced stage patients (TL-2 and TL-3) without radiotherapy by using intensified consolidation chemotherapy (DECOPDAC-21). 2.To demonstrate in ERA PET-positive TL-2 and TL-3 patients that the combination of intensified consolidation chemotherapy (DECOPDAC-21) plus restricted field RT to sites that remain FDG-PET positive at the late response assessment (LRA) is comparable to the standard consolidation chemotherapy (COPDAC-28) plus standard involved node radiotherapy. 3.4.1.2Non-randomised 3.To further reduce the radiotherapy indication in early stage patients by increasing the threshold for a positive FDG PET scan at early response assessment (ERA) to Deauville 4+ while still preserving a 5 year EFS estimate at a target of 90% or above. ;Secondary Objective: 1.Evaluation of haematotoxicity by documentation of blood count courses during OEPA, COPDAC-28 and DECOPDAC-21 cycles and comparison between COPDAC-28 versus DECOPDAC-21. 2.For ERA PET-positive patients to compare the LRA PET-positivity rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21. ;Primary end point(s): 3.5.1Primary efficacy endpoint •Event-free survival (EFS) defined as time from start of treatment until the first of the following events: oprogression/relapse of disease osecondary malignancy odeath from any cause;Timepoint(s) of evaluation of this end point: Descriptive data analyses will be performed annually checking data integrity, monitoring study performance quality endpoints as well as describing treatment related toxicities for the annual safety report. The clinical board of EuroNet-PHL will decide on adequate measures in response to potential findings. The DMC may be consulted for independent guidance if there is a potential change in the risk-benefit analysis or lack of consensus in the clinical board. Interim analyses on efficacy will be pe | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 3.5.2 Secondary endpoints • Efficacy: overall survival (OS), progression-free survival (PFS) • Safety: CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis • Quality: o Time from day of PET imaging until decision on response category at ERA or LRA, respectively o Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication o Time from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle o Duration of chemotherapy o Chemotherapy dose actually administered divided by scheduled total dose for each drug ;Timepoint(s) of evaluation of this end point: Descriptive data analyses will be performed annually checking data integrity, monitoring study performance quality endpoints as well as describing treatment related toxicities for the annual safety report. The clinical board of EuroNet-PHL will decide on adequate measures in response to potential findings. The DMC may be consulted for independent guidance if there is a potential change in the risk-benefit analysis or lack of consensus in the clinical board. Interim analyses on efficacy will be performed annually starting in year three after the start of accrual when a meaningful number of patients will be on study for more than one year. | — |
Countries
Australia, Austria, Belgium, Czechia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactZentrum für Kinderheilkunde
Justus Liebig University of Giessen
Outcome results
None listed