Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01949129
Registration number
NCT01949129
Ethics application status
Date submitted
9/09/2013
Date registered
24/09/2013
Date last updated
16/01/2024
Titles & IDs
Public title
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Query!
Scientific title
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Query!
Secondary ID [1]
0
0
ALL SCTped FORUM 2012
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukaemia
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
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 used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:
* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
Active comparator: TBI/VP16 - TBI (Total Body Irradiation) / VP16 is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients older than 48 months with:
* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide.
Patients aged 24-48 months may optionally receive Total Body Irradiation (TBI).
Experimental: Flu/Thio/ivBu - Fludarabine/Thiotepa/iV Busulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:
* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
Experimental: Bu/VP16/Cy - Busulfan/VP16/Cyclophosphamide is an alternative conditioning arm that may optionally be used for HSCT with MSD/MD and MMD graft in patients aged 0-24 months. Patients undergoing MD HSCT will also receive ATG Thymo- or Grafalon.
Treatment: Drugs: VP16
60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning
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
as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Query!
Primary outcome [2]
0
0
Event free survival (EFS) Stratum 2 (mismatched donor transplantation)
Query!
Assessment method [2]
0
0
EFS after allogeneic HSCT. EFS calculated from date of recruitment to disease progression or relapse, secondary neoplasm and death from any cause.
Query!
Timepoint [2]
0
0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Query!
Primary outcome [3]
0
0
Overall Survival (OS), Stratum 1b: MSD/MD without randomisation
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Query!
Secondary outcome [1]
0
0
EFS (Stratum 1a and 1b)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Query!
Secondary outcome [2]
0
0
TRM
Query!
Assessment method [2]
0
0
Cumulative Incidence of Treatment-related mortality (TRM) for Stratum 1 and 2.
Query!
Timepoint [2]
0
0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Query!
Secondary outcome [3]
0
0
Relapse/progression
Query!
Assessment method [3]
0
0
Cumulative Incidence of Relapse for Stratum 1a, 1b and 2.
Query!
Timepoint [3]
0
0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Query!
Secondary outcome [4]
0
0
Acute and late toxicity for Stratum 1a, 1b and 2
Query!
Assessment method [4]
0
0
according a preselection out of CTC3
Query!
Timepoint [4]
0
0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Query!
Secondary outcome [5]
0
0
OS (Stratum 2)
Query!
Assessment method [5]
0
0
The primary endpoint is the OS calculated from the date of the recruitment . Death from any cause will be considered an event.
Query!
Timepoint [5]
0
0
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Query!
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
Query!
Minimum age
1
Month
Query!
Query!
Maximum age
18
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/04/2030
Query!
Actual
Query!
Sample size
Target
1800
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Children's Cancer Centre The Royal Children's Hospital - Melbourne
Query!
Recruitment hospital [2]
0
0
Princess Margaret Hospital for Children - Perth
Query!
Recruitment hospital [3]
0
0
Sydney Children's Hospital - Randwick
Query!
Recruitment hospital [4]
0
0
Lady Cilento Children's Hospital - South Brisbane
Query!
Recruitment hospital [5]
0
0
The Children's Hospital at Westmead Oncology Unit - Sydney
Query!
Recruitment postcode(s) [1]
0
0
3052 - Melbourne
Query!
Recruitment postcode(s) [2]
0
0
6008 - Perth
Query!
Recruitment postcode(s) [3]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
2145 - Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
La Plata
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Graz
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Innsbruck
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Vienna
Query!
Country [6]
0
0
Belarus
Query!
State/province [6]
0
0
Minsk
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Brussels
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Gent
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Leuven
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Liège
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Calgary
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Montral
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Montreal
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Toronto
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Vancouver
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Winnipeg
Query!
Country [17]
0
0
Chile
Query!
State/province [17]
0
0
Santiago
Query!
Country [18]
0
0
Croatia
Query!
State/province [18]
0
0
Zagreb
Query!
Country [19]
0
0
Czechia
Query!
State/province [19]
0
0
Prague
Query!
Country [20]
0
0
Denmark
Query!
State/province [20]
0
0
Copenhagen
Query!
Country [21]
0
0
Finland
Query!
State/province [21]
0
0
Helsinki
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Bordeaux
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Clermont-Ferrand
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Grenoble
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Lille
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Lyon
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Marseille
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Montpellier
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Nancy
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Nantes
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Paris
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Rennes
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Rouen
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Strasbourg
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Aachen
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Berlin
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Bonn
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Düsseldorf
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Erlangen
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Essen
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Frankfurt am Main
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Freiburg
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Gießen
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Greifswald
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Halle
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Hamburg
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Hannover
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Heidelberg
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Jena
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Kiel
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Leipzig
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
München
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Münster
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Regensburg
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Tübingen
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Ulm
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Würzburg
Query!
Country [58]
0
0
Greece
Query!
State/province [58]
0
0
Athens
Query!
Country [59]
0
0
Hungary
Query!
State/province [59]
0
0
Budapest
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Haifa
Query!
Country [61]
0
0
Israel
Query!
State/province [61]
0
0
Petach-Tikva
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Tel Aviv
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Bologna
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Florence
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Genoa
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Monza
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Napoli
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Padova
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Pavia
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Pisa
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Rome
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Torino
Query!
Country [73]
0
0
Malaysia
Query!
State/province [73]
0
0
Kuala Lumpur
Query!
Country [74]
0
0
Mexico
Query!
State/province [74]
0
0
Ciudad de México
Query!
Country [75]
0
0
Netherlands
Query!
State/province [75]
0
0
Leiden
Query!
Country [76]
0
0
Netherlands
Query!
State/province [76]
0
0
Utrecht
Query!
Country [77]
0
0
New Zealand
Query!
State/province [77]
0
0
Auckland
Query!
Country [78]
0
0
Norway
Query!
State/province [78]
0
0
Oslo
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Bydgoszcz
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Kraków
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Lublin
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Poznan
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Wroclaw
Query!
Country [84]
0
0
Romania
Query!
State/province [84]
0
0
Bukarest
Query!
Country [85]
0
0
Romania
Query!
State/province [85]
0
0
Timisoara
Query!
Country [86]
0
0
Saudi Arabia
Query!
State/province [86]
0
0
Riyadh
Query!
Country [87]
0
0
Slovakia
Query!
State/province [87]
0
0
Bratislava
Query!
Country [88]
0
0
Slovenia
Query!
State/province [88]
0
0
Ljubljana
Query!
Country [89]
0
0
Spain
Query!
State/province [89]
0
0
Barcelona
Query!
Country [90]
0
0
Spain
Query!
State/province [90]
0
0
Murcia
Query!
Country [91]
0
0
Spain
Query!
State/province [91]
0
0
Málaga
Query!
Country [92]
0
0
Spain
Query!
State/province [92]
0
0
Oviedo
Query!
Country [93]
0
0
Sweden
Query!
State/province [93]
0
0
Göteborg
Query!
Country [94]
0
0
Sweden
Query!
State/province [94]
0
0
Lund
Query!
Country [95]
0
0
Sweden
Query!
State/province [95]
0
0
Stockholm
Query!
Country [96]
0
0
Sweden
Query!
State/province [96]
0
0
Uppsala
Query!
Country [97]
0
0
Switzerland
Query!
State/province [97]
0
0
Basel
Query!
Country [98]
0
0
Switzerland
Query!
State/province [98]
0
0
Geneva
Query!
Country [99]
0
0
Switzerland
Query!
State/province [99]
0
0
Zurich
Query!
Country [100]
0
0
Turkey
Query!
State/province [100]
0
0
Ankara
Query!
Country [101]
0
0
Turkey
Query!
State/province [101]
0
0
Antalya
Query!
Country [102]
0
0
Turkey
Query!
State/province [102]
0
0
Istanbul
Query!
Country [103]
0
0
Turkey
Query!
State/province [103]
0
0
Izmir
Query!
Country [104]
0
0
Turkey
Query!
State/province [104]
0
0
Kayseri
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
St. Anna Kinderkrebsforschung
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
ALL SCTped Forum
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
European Society for Blood and Marrow Transplantation
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
ALL-BFM Study Group
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
Query!
Name [4]
0
0
Assistance Publique - Hôpitaux de Paris
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Other collaborator category [5]
0
0
Other
Query!
Name [5]
0
0
Dutch Childhood Oncology Group
Query!
Address [5]
0
0
Query!
Country [5]
0
0
Query!
Other collaborator category [6]
0
0
Other
Query!
Name [6]
0
0
Swiss Pediatric Oncology Group
Query!
Address [6]
0
0
Query!
Country [6]
0
0
Query!
Other collaborator category [7]
0
0
Other
Query!
Name [7]
0
0
Australian & New Zealand Children's Haematology/Oncology Group
Query!
Address [7]
0
0
Query!
Country [7]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01949129
Query!
Trial related presentations / publications
Gomez SM, Varela MA, Ruiz C, Sung L. Comparable Outcomes of Matched Sibling Donor and Matched Unrelated Donor Stem Cell Transplantation in Children With Acute Leukemia in Argentina. J Pediatr Hematol Oncol. 2021 Oct 1;43(7):e1020-e1024. doi: 10.1097/MPH.0000000000002174. Peters C, Dalle JH, Locatelli F, Poetschger U, Sedlacek P, Buechner J, Shaw PJ, Staciuk R, Ifversen M, Pichler H, Vettenranta K, Svec P, Aleinikova O, Stein J, Gungor T, Toporski J, Truong TH, Diaz-de-Heredia C, Bierings M, Ariffin H, Essa M, Burkhardt B, Schultz K, Meisel R, Lankester A, Ansari M, Schrappe M; IBFM Study Group;; von Stackelberg A; IntReALL Study Group; Balduzzi A; I-BFM SCT Study Group; Corbacioglu S; EBMT Paediatric Diseases Working Party; Bader P. Total Body Irradiation or Chemotherapy Conditioning in Childhood ALL: A Multinational, Randomized, Noninferiority Phase III Study. J Clin Oncol. 2021 Feb 1;39(4):295-307. doi: 10.1200/JCO.20.02529. Epub 2020 Dec 17. Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available. Choong E, Uppugunduri CRS, Marino D, Kuntzinger M, Doffey-Lazeyras F, Lo Piccolo R, Chalandon Y, Peters C, Daali Y, Ansari M. Therapeutic Drug Monitoring of Busulfan for the Management of Pediatric Patients: Cross-Validation of Methods and Long-Term Performance. Ther Drug Monit. 2018 Feb;40(1):84-92. doi: 10.1097/FTD.0000000000000468. Erratum In: Ther Drug Monit. 2018 Apr;40(2):284. doi: 10.1097/FTD.0000000000000489.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Christina Peters, Prof. MD PhD
Query!
Address
0
0
St. Anna Kinderspital, Vienna, Austria
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Christina Peters, Prof. MD PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+43140170
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
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/NCT01949129
Download to PDF