Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01802814


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT01802814
Ethics application status
Date submitted
18/02/2013
Date registered
1/03/2013
Date last updated
9/02/2024

Titles & IDs
Public title
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
Scientific title
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group
Secondary ID [1] 0 0
IntReALL SR 2010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia (ALL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No intervention: SR-A - Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized not to receive epratuzumab.This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.

Active comparator: SR-A + Epratuzumab - Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.

No intervention: SR-B - Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized not to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.

Active comparator: SR-B + Epratuzumab - Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SR induction/consolidation ALL-REZ BFM 2002 versus UK-ALL-R3 (randomisation 1)
Timepoint [1] 0 0
Up to 9 years
Primary outcome [2] 0 0
SR consolidation +/- epratuzumab (randomisation 2)
Timepoint [2] 0 0
Up to 9 years
Secondary outcome [1] 0 0
SR induction/consolidation
Timepoint [1] 0 0
Up to 9 years
Secondary outcome [2] 0 0
SR consolidation +/- epratuzumab
Timepoint [2] 0 0
Up to 9 years

Eligibility
Key inclusion criteria
* Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
* Children less than 18 years of age at inclusion
* Meeting SR criteria: late isolated or late/early combined B-cell precursor (BCP) bone marrow (BM) relapse, any late/early isolated 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 days prior to study enrolment that interfere with this protocol, except trials for primary ALL Inclusion criteria specific for the epratuzumab randomization
* Precursor B-cell immunophenotype. A specific CD22 expression level is not required
* M1 or M2 status of the bone marrow after induction
Minimum age
1 Day
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 antileukemic therapy
* Breast feeding
* Relapse post allogeneic stem-cell transplantation
* 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)
* Karnovsky / Lansky score < 50%
* Subjects unwilling or unable to comply with the study procedures
* Subjects who are legally detained in an official institute

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2023
Sample size
Target
Accrual to date
Final
700
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian & New Zealand Childhood Hematology & Oncology Group - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague
Country [4] 0 0
Denmark
State/province [4] 0 0
Copenhagen
Country [5] 0 0
Finland
State/province [5] 0 0
Turku
Country [6] 0 0
France
State/province [6] 0 0
Nice
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Israel
State/province [8] 0 0
Tel Aviv
Country [9] 0 0
Italy
State/province [9] 0 0
Roma
Country [10] 0 0
Japan
State/province [10] 0 0
Tokyo
Country [11] 0 0
Netherlands
State/province [11] 0 0
Utrecht
Country [12] 0 0
Norway
State/province [12] 0 0
Oslo
Country [13] 0 0
Poland
State/province [13] 0 0
Wroclaw
Country [14] 0 0
Portugal
State/province [14] 0 0
Lisboa
Country [15] 0 0
Switzerland
State/province [15] 0 0
Zürich
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Other
Name
Charite University, Berlin, Germany
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian & New Zealand Children's Haematology/Oncology Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
St. Anna Kinderkrebsforschung (Co-Sponsor Austria)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
European Organisation for Research and Treatment of Cancer - EORTC
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University Hospital Motol (Co-Sponsor Czech Republic)
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen)
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Turku University (Co-Sponsor Finland)
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Centre Hospitalier Universitaire de Nice
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Ospedale Pediatrico Bambino Gesù (Co-Sponsor Italy)
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
National Hospital Organization Nagoya Medical Center (Co-Sponsor Japan)
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Prinses Máxima Centrum (Co-Sponsor Netherlands)
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Oslo University Hospital (Co-Sponsor Oslo)
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Medical University of Wroclaw (Co-Sponsor Poland)
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Instituto Português de Oncologia de Lisboa (Co-Sponsor Lisboa)
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
University Children's Hospital, Zurich
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
Central Manchester University (Co-Sponsor United Kingdom)
Address [18] 0 0
Country [18] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arend von Stackelberg, MD
Address 0 0
University Hospital of Berlin - Charité
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01802814

Additional trial details provided through ANZCTR
Accrual to date
38
Recruiting in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 61
The Children's Hospital at Westmead
Recruitment hospital [2] 62
The Royal Childrens Hospital
Recruitment hospital [3] 63
John Hunter Children's Hospital
Recruitment hospital [4] 64
Queensland Children's Hospital
Recruitment hospital [5] 65
Womens and Childrens Hospital
Recruitment hospital [6] 66
Sydney Children's Hospital
Recruitment hospital [7] 67
Princess Margaret Hospital
Recruitment hospital [8] 68
Monash Medical Centre - Clayton campus
Recruitment postcode(s) [1] 65
2145
Recruitment postcode(s) [2] 66
3052
Recruitment postcode(s) [3] 67
2305
Recruitment postcode(s) [4] 68
4101
Recruitment postcode(s) [5] 69
5006
Recruitment postcode(s) [6] 70
2031
Recruitment postcode(s) [7] 71
6008
Recruitment postcode(s) [8] 72
3168
Recruiting in New Zealand
Province(s)/district(s)
Christchurch Children's Hospital, Christchurch Starship Children's Hospital, Auckland
Funding & Sponsors
Primary sponsor
University
Primary sponsor name
Charité – Universitätsmedizin Berlin
Primary sponsor address
Campus Virchow Klinikum
Augustenburger Platz 1
13353 Berlin
Primary sponsor country
Germany
Secondary sponsor category [1] 68
Other Collaborative groups
Name [1] 68
ANZCHOG
Address [1] 68
ANZCHOG Hudson Institute of Medical Research Level 6, TRF Building 27-31 Wright St, Clayton, Victoria 3168
Country [1] 68
Australia
Ethics approval
Ethics application status
Approved
 
Public notes
This trial is closed to recruitment

Contacts
Principal investigator
Title 169 0
Dr
Name 169 0
Arend von Stackelberg
Address 169 0
Country 169 0
Germany
Phone 169 0
Fax 169 0
Email 169 0
Contact person for public queries
Title 170 0
Dr
Name 170 0
Tom Revesz
Address 170 0
Country 170 0
Australia
Phone 170 0
Fax 170 0
Email 170 0
Contact person for scientific queries
Title 171 0
Dr
Name 171 0
Tom Revesz
Address 171 0
Country 171 0
Australia
Phone 171 0
Fax 171 0
Email 171 0