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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01949129




Registration number
NCT01949129
Ethics application status
Date submitted
9/09/2013
Date registered
24/09/2013
Date last updated
28/06/2019

Titles & IDs
Public title
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Scientific title
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Secondary ID [1] 0 0
ALL SCTped FORUM 2012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukaemia 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VP16
Treatment: Other - TBI
Treatment: Drugs - Thiotepa
Treatment: Drugs - Treosulfan
Treatment: Drugs - Fludarabine
Treatment: Drugs - Busulfan
Treatment: Drugs - ATG Thymoglobulin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Grafalon

Experimental: Flu/Thio/Treo - Fludarabine/Thiotepa/Treosulfan is for conditioning before HSCT from MSD or MD. ATG Thymo or Grafalon is used for patients who receive stem cells from unrelated donors.
Fludarabine/Thiotepa/Treosulfan with either ATG Thymo or Grafalon is also used for HSCT from MMD with in vitro T-Cell Depletion (TCD) or with CD34+ selection.
Fludarabine/Thiotepa/Treosulfan with Post Tx-Cyclophosphamide is used for MMD-graft without in vitro TCD.

Active Comparator: TBI/VP16 - TBI (Total Body Irradiation) / VP16 is used for conditioning for HSCT with MSD or MD graft with patients who are older than 48 months at the time of conditioning.
TBI/VP16 is also used with Post TX-Cyclophosphamide for MMD-graft without in vitro T-Cell Depletion.
TBI/VP16 with either ATG Thymo or Grafalon is used for MMD-HSCT with in vitro T-Cell Depletion or with CD34+ selection.

Experimental: Flu/Thio/ivBu - Fludarabine/Thiotepa/iV Busulfan is used for conditioning before HSCT from MSD or MD.
Fludarabine/Thiotepa/iBu with either ATG Thymo or Grafalon is also used for HSCT from MMD-HSCT with T-Cell Depletion (TCD) or haplo with CD34+ selection.
Fludarabine/Thiotepa/iV Busulfan with Post Tx-Cyclophosphamide is used for MMD-graft without in vitro TCD.


Treatment: Drugs: VP16
60 mg/kg BW,1 day

Treatment: Other: TBI
2 x 2Gy/day , 3 days (total 12Gy)

Treatment: Drugs: Thiotepa
2x5 mg/kg BW, 1 day

Treatment: Drugs: Treosulfan
14g/m² BS, 3 days

Treatment: Drugs: Fludarabine
30 mg/m² BS, 5 days

Treatment: Drugs: Busulfan
iV, dosage according therapeutic drug monitoring, 4 days

Treatment: Drugs: ATG Thymoglobulin
MD: ATG Thymo: 2,5mg/kg BW/d 3 days.

Treatment: Drugs: Cyclophosphamide
50mg/kg BW/d 2 days with Mesna

Treatment: Drugs: Grafalon
MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only) - Stratum 1 - randomisation related question was closed in December 2018; patients are in active follow-up: To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD). The primary endpoint is the OS calculated from the date of the randomisation. Death from any cause will be considered an event.
Timepoint [1] 0 0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Primary outcome [2] 0 0
Event free survival (EFS) Stratum 2 (mismatched donor transplantation) - EFS after allogeneic HSCT. EFS calculated from date of recruitment to disease progression or relapse, secondary neoplasm and death from any cause.
Timepoint [2] 0 0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Primary outcome [3] 0 0
Overall Survival (OS), Stratum 1b: MSD/MD without randomisation - To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire MSD/MD cohort
Timepoint [3] 0 0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Secondary outcome [1] 0 0
EFS (Stratum 1a and 1b) - EFS calculated from date of randomization (1a) or recruitment (1b) to disease progression or relapse, secondary neoplasm and death from any cause. Patients lost to follow-up without event will be censored at the date of their last follow-up evaluation.
Timepoint [1] 0 0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Secondary outcome [2] 0 0
TRM - Cumulative Incidence of Treatment-related mortality (TRM) for Stratum 1 and 2.
Timepoint [2] 0 0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Secondary outcome [3] 0 0
Relapse/progression - Cumulative Incidence of Relapse for Stratum 1a, 1b and 2.
Timepoint [3] 0 0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Secondary outcome [4] 0 0
Acute and late toxicity for Stratum 1a, 1b and 2 - according a preselection out of CTC3
Timepoint [4] 0 0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Secondary outcome [5] 0 0
OS (Stratum 2) - The primary endpoint is the OS calculated from the date of the recruitment . Death from any cause will be considered an event.
Timepoint [5] 0 0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Eligibility
Key inclusion criteria
Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

- age at diagnosis = 18 years. Age at HSCT = 21 years

- indication for allogeneic HSCT

- complete remission (CR) before HSCT

- written consent of the parents (legal guardian) and, if necessary, the minor patient
via "Informed Consent Form"

- no pregnancy

- no secondary malignancy

- no previous HSCT

- HSCT is performed in a study participating centre
Minimum age
6 Months
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- patients who do not fulfil the inclusion criteria

- Non Hodgkin-Lymphoma

- 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 anonymous 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)

- Karnofsky / Lansky score < 50%

- subjects unwilling or unable to comply with the study procedures

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
Parallel
Other design features
Phase
Phase 2/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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Children's Cancer Centre The Royal Children's Hospital - Melbourne
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [3] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [4] 0 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [5] 0 0
The Children`s Hospital at Westmead Oncology Unit - Sydney
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment postcode(s) [2] 0 0
6008 - Perth
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
La Plata
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Austria
State/province [4] 0 0
Innsbruck
Country [5] 0 0
Austria
State/province [5] 0 0
Vienna
Country [6] 0 0
Belarus
State/province [6] 0 0
Minsk
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Belgium
State/province [10] 0 0
Liège
Country [11] 0 0
Canada
State/province [11] 0 0
Calgary
Country [12] 0 0
Canada
State/province [12] 0 0
Montral
Country [13] 0 0
Canada
State/province [13] 0 0
Montreal
Country [14] 0 0
Canada
State/province [14] 0 0
Toronto
Country [15] 0 0
Canada
State/province [15] 0 0
Vancouver
Country [16] 0 0
Canada
State/province [16] 0 0
Winnipeg
Country [17] 0 0
Chile
State/province [17] 0 0
Santiago
Country [18] 0 0
Croatia
State/province [18] 0 0
Zagreb
Country [19] 0 0
Czechia
State/province [19] 0 0
Prague
Country [20] 0 0
Denmark
State/province [20] 0 0
Copenhagen
Country [21] 0 0
Finland
State/province [21] 0 0
Helsinki
Country [22] 0 0
France
State/province [22] 0 0
Bordeaux
Country [23] 0 0
France
State/province [23] 0 0
Clermont-Ferrand
Country [24] 0 0
France
State/province [24] 0 0
Grenoble
Country [25] 0 0
France
State/province [25] 0 0
Lille
Country [26] 0 0
France
State/province [26] 0 0
Lyon
Country [27] 0 0
France
State/province [27] 0 0
Marseille
Country [28] 0 0
France
State/province [28] 0 0
Montpellier
Country [29] 0 0
France
State/province [29] 0 0
Nancy
Country [30] 0 0
France
State/province [30] 0 0
Nantes
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Rennes
Country [33] 0 0
France
State/province [33] 0 0
Rouen
Country [34] 0 0
France
State/province [34] 0 0
Strasbourg
Country [35] 0 0
Germany
State/province [35] 0 0
Aachen
Country [36] 0 0
Germany
State/province [36] 0 0
Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Bonn
Country [38] 0 0
Germany
State/province [38] 0 0
Düsseldorf
Country [39] 0 0
Germany
State/province [39] 0 0
Erlangen
Country [40] 0 0
Germany
State/province [40] 0 0
Essen
Country [41] 0 0
Germany
State/province [41] 0 0
Frankfurt am Main
Country [42] 0 0
Germany
State/province [42] 0 0
Freiburg
Country [43] 0 0
Germany
State/province [43] 0 0
Gießen
Country [44] 0 0
Germany
State/province [44] 0 0
Greifswald
Country [45] 0 0
Germany
State/province [45] 0 0
Halle
Country [46] 0 0
Germany
State/province [46] 0 0
Hamburg
Country [47] 0 0
Germany
State/province [47] 0 0
Hannover
Country [48] 0 0
Germany
State/province [48] 0 0
Heidelberg
Country [49] 0 0
Germany
State/province [49] 0 0
Jena
Country [50] 0 0
Germany
State/province [50] 0 0
Kiel
Country [51] 0 0
Germany
State/province [51] 0 0
Leipzig
Country [52] 0 0
Germany
State/province [52] 0 0
München
Country [53] 0 0
Germany
State/province [53] 0 0
Münster
Country [54] 0 0
Germany
State/province [54] 0 0
Regensburg
Country [55] 0 0
Germany
State/province [55] 0 0
Tübingen
Country [56] 0 0
Germany
State/province [56] 0 0
Ulm
Country [57] 0 0
Germany
State/province [57] 0 0
Würzburg
Country [58] 0 0
Greece
State/province [58] 0 0
Athens
Country [59] 0 0
Hungary
State/province [59] 0 0
Budapest
Country [60] 0 0
Israel
State/province [60] 0 0
Haifa
Country [61] 0 0
Israel
State/province [61] 0 0
Petach-Tikva
Country [62] 0 0
Israel
State/province [62] 0 0
Tel Aviv
Country [63] 0 0
Italy
State/province [63] 0 0
Bologna
Country [64] 0 0
Italy
State/province [64] 0 0
Florence
Country [65] 0 0
Italy
State/province [65] 0 0
Genoa
Country [66] 0 0
Italy
State/province [66] 0 0
Monza
Country [67] 0 0
Italy
State/province [67] 0 0
Napoli
Country [68] 0 0
Italy
State/province [68] 0 0
Padova
Country [69] 0 0
Italy
State/province [69] 0 0
Pavia
Country [70] 0 0
Italy
State/province [70] 0 0
Pisa
Country [71] 0 0
Italy
State/province [71] 0 0
Rome
Country [72] 0 0
Italy
State/province [72] 0 0
Torino
Country [73] 0 0
Malaysia
State/province [73] 0 0
Kuala Lumpur
Country [74] 0 0
Mexico
State/province [74] 0 0
Ciudad de México
Country [75] 0 0
Netherlands
State/province [75] 0 0
Leiden
Country [76] 0 0
Netherlands
State/province [76] 0 0
Utrecht
Country [77] 0 0
New Zealand
State/province [77] 0 0
Auckland
Country [78] 0 0
Norway
State/province [78] 0 0
Oslo
Country [79] 0 0
Poland
State/province [79] 0 0
Bydgoszcz
Country [80] 0 0
Poland
State/province [80] 0 0
Kraków
Country [81] 0 0
Poland
State/province [81] 0 0
Lublin
Country [82] 0 0
Poland
State/province [82] 0 0
Poznan
Country [83] 0 0
Poland
State/province [83] 0 0
Wroclaw
Country [84] 0 0
Romania
State/province [84] 0 0
Bukarest
Country [85] 0 0
Romania
State/province [85] 0 0
Timisoara
Country [86] 0 0
Saudi Arabia
State/province [86] 0 0
Riyadh
Country [87] 0 0
Slovakia
State/province [87] 0 0
Bratislava
Country [88] 0 0
Slovenia
State/province [88] 0 0
Ljubljana
Country [89] 0 0
Spain
State/province [89] 0 0
Barcelona
Country [90] 0 0
Spain
State/province [90] 0 0
El Palmar
Country [91] 0 0
Spain
State/province [91] 0 0
Málaga
Country [92] 0 0
Spain
State/province [92] 0 0
Oviedo
Country [93] 0 0
Sweden
State/province [93] 0 0
Göteborg
Country [94] 0 0
Sweden
State/province [94] 0 0
Lund
Country [95] 0 0
Sweden
State/province [95] 0 0
Stockholm
Country [96] 0 0
Sweden
State/province [96] 0 0
Uppsala
Country [97] 0 0
Switzerland
State/province [97] 0 0
Basel
Country [98] 0 0
Switzerland
State/province [98] 0 0
Geneva
Country [99] 0 0
Switzerland
State/province [99] 0 0
Zurich
Country [100] 0 0
Turkey
State/province [100] 0 0
Ankara
Country [101] 0 0
Turkey
State/province [101] 0 0
Antalya
Country [102] 0 0
Turkey
State/province [102] 0 0
Istanbul
Country [103] 0 0
Turkey
State/province [103] 0 0
Izmir
Country [104] 0 0
Turkey
State/province [104] 0 0
Kayseri

Funding & Sponsors
Primary sponsor type
Other
Name
St. Anna Kinderkrebsforschung
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ALL SCTped Forum
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III
study for the therapy and therapy optimisation for children and adolescents with ALL in
complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in
cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with
a myeloablative conditioning regimen.

The stratification of patients in first and following remissions according to the individual
transplantation modalities rests upon an indication for allogeneic HSCT and the availability
of a suitable donor within the individual transplantation groups.
Trial website
https://clinicaltrials.gov/show/NCT01949129
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christina Peters, Prof. MD PhD
Address 0 0
St. Anna Kinderspital, Vienna, Austria
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christina Peters, Prof. MD PhD
Address 0 0
Country 0 0
Phone 0 0
+43140170
Fax 0 0
Email 0 0
christina.peters@stanna.at
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01949129