Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - SR-A + Epratuzumab
Treatment: Drugs - SR-B + Epratuzumab

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.


Treatment: Drugs: SR-A + Epratuzumab


Treatment: Drugs: SR-B + Epratuzumab
Intervention code [1] 0 0
Treatment: Drugs
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
The main goal of this study is to improve the outcome of children and adolescents with
standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set
up a large international study group platform allowing for optimization of standard treatment
strategies and integration of new agents.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01802814
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 are available at https://clinicaltrials.gov/ct2/show/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