IntReALL HR 2010 International Study for Treatment of Standard Risk Childhood Relapsed Acute Lymphoblastic Leukemia 2010

• Register: EUCTR
• Last refreshed on: 29 January 2018
• Main ID: EUCTR2012-000810-12-AT
• Date of registration: 03/03/2016
• Prospective Registration: Yes
• Primary sponsor: Charité - Universitätsmedizin Berlin
• Public title: IntReALL HR 2010 International Study for Treatment of Standard Risk Childhood Relapsed Acute Lymphoblastic Leukemia 2010
• Scientific title: IntReALL HR 2010 International Study for Treatment of High Risk Childhood Relapsed ALL 2010 - IntReALL-HR-2010
• Date of first enrolment: 16/03/2016
• Target sample size: 250
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000810-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Portugal, Sweden, Switzerland

Contacts

• Name: Dept of Pediatric Oncology/Hematolo
• Affiliation: Charité - Universitätsmedizin Berlin

• Name: Dept of Pediatric Oncology/Hematolo
• Affiliation: Charité - Universitätsmedizin Berlin

Key inclusion & exclusion criteria

Inclusion criteria:
- Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
- Children less than 18 years of age at date of inclusion into the study
- Meeting HR criteria (any T BM relapse, early/very early isolated/combined extramedullary relapse)
- Patient enrolled in a participating centre
- Written informed consent
- Start of treatment falling into the study period
- No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL
Are the trial subjects under 18? yes
Number of subjects for this age range: 250
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:
- BCR-ABL/ t(9;22) positive ALL
- Pregnancy or positive pregnancy test (urine sample positive for ß-HCG > 10 U/l)
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl
index <1) until 2 years after end of anti-leukemic therapy
- Breast feeding
- Relapse post allogeneic stem-cell transplantation
- Neuropathy > II
- The whole protocol or essential parts are declined either by patient himself/herself or the
respective legal guardian
- No consent is given for saving and propagation of pseudonymized medical data for study
reasons
- Severe concomitant disease that does not allow treatment according to the protocol at the
investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic
disorders)
- Subjects unwilling or unable to comply with the study procedures
- Subjects who are legally detained in an official institute


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Acute lymphoblastic leukemia (ALL)

Intervention(s)

Trade Name: Velcade
Product Name: Velcade
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Other descriptive name: VELCADE
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 3.5-

Product Name: Asparaginase
Pharmaceutical Form: Powder for suspension for injection
CAS Number: 9015-68-3
Other descriptive name: ASPARAGINASE
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 5000-

Product Name: Dexamethasone
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE BASE
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 3,3-

Product Name: Vincristine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Vincristine Sulfate
Other descriptive name: VINCRISTINE SULFATE
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal

Product Name: Methotrexate
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: Methotrexate
CAS Number: 59-05-2
Other descriptive name: METHOTREXATE
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 1-

Product Name: Mitoxantrone
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: Mitoxantrone Hydrochloride
Other descriptive name: MITOXANTRONE HYDROCHLORIDE PH. EUR.
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Secondary Objective: Improvement of EFS and OS rates
Improvement of MRD reduction after induction with versus without bortezomib
Toxicity of induction with versus without bortezomib
Efficacy of consolidation elements to reduce MRD load until allo-HSCT

Main Objective: Improvement of CR rates after induction with ALL R3 with bortezomib versus without bortezomib in HR relapsed ALL patients

Primary end point(s): Primary endpoint of this trial is the rate of complete remission (CR2) quantified by cytology after induction with standard chemotherapy + bortezomib (arm B) compared with standard chemotherapy (arm A)

Timepoint(s) of evaluation of this end point: Primary endpoint will be evaluated at week 5 after induction.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: End of study

Secondary end point(s): Secondary endpoints are improvement of three years EFS and OS, rate of patients reaching HSCT, MRD rates post induction and pre-HSCT, prognostic relevance of MRD pre-HSCT, C2 and MRD rates during consolidation, toxicity of randomized arms.

Secondary ID(s)

2012-000810-12-SE

IntReALL-HR-2010

Source(s) of Monetary Support

EU Project FP7