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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05327894


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


Registration number
NCT05327894
Ethics application status
Date submitted
7/04/2022
Date registered
14/04/2022

Titles & IDs
Public title
Interfant-21 Treatment Protocol for Infants Under 1 Year with KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Scientific title
Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year with KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.
Secondary ID [1] 0 0
2021-000213-16
Universal Trial Number (UTN)
Trial acronym
Interfant-21
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia 0 0
Mixed Phenotype Acute Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Blinatumomab
Treatment: Drugs - Blinatumomab

Other: Medium Risk (MR) - Subject is defined as MR if \> 6months of age at diagnosis, OR \< 6 months of age with White Blood cell Count (WBC) \< 300 at diagnosis and good prednisone response. Subject gets 1st cycle of blinatumomab. If MRD is \>0.01%, after 1st cycle of blinatumomab, subject will be allocated to HR treatment from that phase, and will be eligible for HSCT. If MRD is undetectable or \< 0.01% after the 1st cycle of blinatumomab (TP2) patient will be eligible for replacement of MARMA by 2nd cycle of blinatumomab after receipt of lymphoid style consolidation (Protocol IB) or of myeloid style consolidation (ADE/MAE).

Other: High risk (HR) - Subject is defined as HR if \< 6 months of age with WBC \> 300 at diagnosis OR poor prednisone response. Also MR patients with end of induction MRD = 1%, or MRD \> 0.01% after the 1st cycle of blinatumomab, will be allocated to HR treatment. Subject gets 1 cycle of blinatumomab.

Thereafter patient is eligible for hematopoietic stem cell transplantation (HSCT) with or without experimental therapy in an investigational window.


Treatment: Drugs: Blinatumomab
1st cycle: 15 µg/m2/day as a 4 week continuous IV infusion for patients with a M1 marrow. For patients with a M2/M3 marrow a step-dosing strategy is required with a dose of 5 µg/m2/day in week 1 followed by 15 µg/m2/day in weeks 2, 3, and 4.

Treatment: Drugs: Blinatumomab
2nd cycle: 15 µg/m2/day as a 4 week continuous iv infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event free survival (EFS).
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
8 years
Secondary outcome [2] 0 0
Endpoints by risk group
Timepoint [2] 0 0
8 years
Secondary outcome [3] 0 0
Outcome for the entire study cohort and according to risk group
Timepoint [3] 0 0
8 years
Secondary outcome [4] 0 0
Minimal Residual Disease
Timepoint [4] 0 0
8 years
Secondary outcome [5] 0 0
CD19 (cluster of differentiation antigen 19) negative relapse
Timepoint [5] 0 0
8 years
Secondary outcome [6] 0 0
Myeloid lineage switches
Timepoint [6] 0 0
8 years
Secondary outcome [7] 0 0
Grade =3 adverse event
Timepoint [7] 0 0
8 years
Secondary outcome [8] 0 0
Grade =2 cardiac disorders
Timepoint [8] 0 0
5 years
Secondary outcome [9] 0 0
Overall survival after 1st relapse
Timepoint [9] 0 0
8 years

Eligibility
Key inclusion criteria
1. Patients with newly diagnosed B- precursor acute lymphoblastic leukemia (ALL) or B- cell mixed phenotype acute leukemia (MPAL) according to the World Health Organization (WHO) classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017, with KMT2A-rearrangement.
2. =365 days of age at time of diagnosis of ALL
3. Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
Minimum age
1 Day
Maximum age
365 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. KMT2A-germline patients
2. T-ALL
3. Age > 365 days at the time of diagnosis
4. Relapsed ALL
5. Treatment with systemic corticosteroids (equivalent prednisone >10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.

Additional exclusion criteria for blinatumomab:

1. CD19 negative B-precursor ALL at diagnosis
2. CNS involvement (CNS2/CNS3 status) at the EOI. Patients with CNS disease at the time of diagnosis are eligible if CNS1 status is achieved prior to the start of the first blinatumomab cycle (lumbar puncture at ~day 33 of induction).
3. Proven hypersensitivity to the active substance or any of the excipients in blinatumomab.
4. Patients who have received a live vaccine 28 days prior to blinatumomab administration or plan to receive a live vaccine prior to B-cell recovery after the last dose of blinatumomab.

If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2030
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian and New Zealand Children's Haematology/Oncology Group - Clayton
Recruitment hospital [2] 0 0
North Adelaide- Womens and Childrens Hospital - Adelaide
Recruitment hospital [3] 0 0
Monash Children's Hosptial - Clayton
Recruitment hospital [4] 0 0
Perth Children's Hospital - Perth
Recruitment hospital [5] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [6] 0 0
Sydney Childrens Hospital - Sydney
Recruitment hospital [7] 0 0
The Childrens Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- South Brisbane
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussel
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Olomouc
Country [5] 0 0
Czechia
State/province [5] 0 0
Brno
Country [6] 0 0
Czechia
State/province [6] 0 0
Prague
Country [7] 0 0
Denmark
State/province [7] 0 0
Aarhus
Country [8] 0 0
Denmark
State/province [8] 0 0
Copenhagen
Country [9] 0 0
Denmark
State/province [9] 0 0
Odense
Country [10] 0 0
Finland
State/province [10] 0 0
Helsinki
Country [11] 0 0
Finland
State/province [11] 0 0
Kuopio
Country [12] 0 0
Finland
State/province [12] 0 0
Oulu
Country [13] 0 0
Finland
State/province [13] 0 0
Tampere
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
Germany
State/province [15] 0 0
Hamburg
Country [16] 0 0
Hungary
State/province [16] 0 0
Pécs
Country [17] 0 0
Ireland
State/province [17] 0 0
Dublin
Country [18] 0 0
Italy
State/province [18] 0 0
Roma
Country [19] 0 0
Japan
State/province [19] 0 0
Chiba
Country [20] 0 0
Japan
State/province [20] 0 0
Ehime
Country [21] 0 0
Japan
State/province [21] 0 0
Hiroshima
Country [22] 0 0
Japan
State/province [22] 0 0
Hokkaido
Country [23] 0 0
Japan
State/province [23] 0 0
Hyogo
Country [24] 0 0
Japan
State/province [24] 0 0
Kagoshima
Country [25] 0 0
Japan
State/province [25] 0 0
Kanagawa
Country [26] 0 0
Japan
State/province [26] 0 0
Kyoto
Country [27] 0 0
Japan
State/province [27] 0 0
Mie
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Saitama
Country [30] 0 0
Japan
State/province [30] 0 0
Shizuoka
Country [31] 0 0
Japan
State/province [31] 0 0
Tohoku
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Lithuania
State/province [33] 0 0
Vilnius
Country [34] 0 0
Netherlands
State/province [34] 0 0
Utrecht
Country [35] 0 0
Norway
State/province [35] 0 0
Trondheim
Country [36] 0 0
Portugal
State/province [36] 0 0
Lisboa
Country [37] 0 0
Saudi Arabia
State/province [37] 0 0
Riyadh
Country [38] 0 0
Slovakia
State/province [38] 0 0
Bratislava
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Sevilla
Country [41] 0 0
Spain
State/province [41] 0 0
Valencia
Country [42] 0 0
Sweden
State/province [42] 0 0
Gothenburg
Country [43] 0 0
Sweden
State/province [43] 0 0
Linkoping
Country [44] 0 0
Sweden
State/province [44] 0 0
Lund
Country [45] 0 0
Sweden
State/province [45] 0 0
Stockholm
Country [46] 0 0
Sweden
State/province [46] 0 0
Umea

Funding & Sponsors
Primary sponsor type
Other
Name
Princess Maxima Center for Pediatric Oncology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Amgen Europe B.V
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Milano Bicocca
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Janine Stutterheim, Dr
Address 0 0
Princess Maxima Center for Pediatric Oncology in The Netherlands
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lieke van den Wildenberg
Address 0 0
Country 0 0
Phone 0 0
0031 88 972 72 72
Fax 0 0
Email 0 0
trialmanagement@prinsesmaximacentrum.nl
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all individual participant data that underlie results in a publication

Supporting document/s available: Clinical study report (CSR)
When will data be available (start and end dates)?
The Clinical Study Report (CSR) will be made available within 6 months upon study end.
Available to whom?
A summary of the study results will be made public via www.clinical trials.gov as well as to Ethical committees/ Health Authorities and all participating patients by providing them through their treating physicians a patient letter with a summary of the results.
Available for what types of analyses?
How or where can data be obtained?


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/NCT05327894

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 134
John Hunter Children's Hospital
Recruitment hospital [2] 135
Monash Children’s Hospital
Recruitment hospital [3] 136
Perth Children's Hospital
Recruitment hospital [4] 137
Queensland Children's Hospital
Recruitment hospital [5] 138
The Royal Childrens Hospital
Recruitment hospital [6] 139
The Children's Hospital at Westmead
Recruitment hospital [7] 140
Womens and Childrens Hospital
Recruitment postcode(s) [1] 135
2305
Recruitment postcode(s) [2] 136
3168
Recruitment postcode(s) [3] 137
6009
Recruitment postcode(s) [4] 138
4101
Recruitment postcode(s) [5] 139
3052
Recruitment postcode(s) [6] 140
2145
Recruitment postcode(s) [7] 141
5006
Recruiting in New Zealand
Province(s)/district(s)
Auckland and Christchurch
Funding & Sponsors
Funding source category [1] 84
Government body
Name [1] 84
Medical Research Future Fund
Address [1] 84
Department of Health and Aged Care GPO Box 9848 Canberra ACT 2601 Australia
Country [1] 84
Australia
Primary sponsor
Charities/Societies/Foundations
Primary sponsor name
The Kid's Cancer Project
Primary sponsor address
The Kids' Cancer Project
PO Box 6400
Alexandria, NSW 2015
Australia
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 61
Child and Adolescent Health Service Human Research Ethics Committee
Address [1] 61
Perth Children's Hospital 15 Hospital Avenue Nedlands Western Australia 6009
Country [1] 61
Australia
Date submitted for ethics approval [1] 61
13/03/2023
Approval date [1] 61
28/04/2023
Ethics approval number [1] 61
RGS0000005973
 
Public notes

Contacts
Principal investigator
Title 385 0
A/Prof
Name 385 0
Rishi Kotecha
Address 385 0
Perth Children's Hospital 15 Hospital Avenue Nedlands Western Australia 6009
Country 385 0
Australia
Phone 385 0
+618 6456 2222
Fax 385 0
Email 385 0
Rishi.kotecha@health.wa.gov.au
Contact person for public queries
Title 386 0
A/Prof
Name 386 0
Rishi Kotecha
Address 386 0
Perth Children's Hospital 15 Hospital Avenue Nedlands Western Australia 6009
Country 386 0
Australia
Phone 386 0
+618 6456 2222
Fax 386 0
Email 386 0
Rishi.kotecha@health.wa.gov.au
Contact person for scientific queries
Title 387 0
A/Prof
Name 387 0
Rishi Kotecha
Address 387 0
Perth Children's Hospital 15 Hospital Avenue Nedlands Western Australia 6009
Country 387 0
Australia
Phone 387 0
+618 6456 2222
Fax 387 0
Email 387 0
Rishi.kotecha@health.wa.gov.au