International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia

Overview[ - collapse ][ - ]

Purpose Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia (ALL). This trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with ALL. Study objectives Primary study questions: - Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone marrow on day 15 <0.1% or with TEL/AML1-positive ALL (randomized study question R1): Can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)? - Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2): Can the clinical outcome be improved by protracted asparagine depletion achieved through application of intensified PEG-L-asparaginase during reintensification and early maintenance? - High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during Protocol IB? Secondary study questions: - Standard risk (SR) patients identified by at least one sensitive marker: Is the clinical outcome comparable to that obtained in SR patients (identified with two sensitive markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of PEG-L-asparaginase instead of native E. coli L-ASP? - T-ALL non-HR patients: Can the high level of outcome which was obtained for these patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of PEG-L-ASP instead of native E. coli L-ASP? - HR patients with persisting high MRD levels despite the use of the HR blocks in the intensified consolidation phase "MRD Non-Responders": Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule (DNX-FLA)? - Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are asparaginase activity and asparaginase antibodies associated with development of allergic reactions, and do they have an effect on the outcome of the patients? - What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol?
ConditionLeukemia
InterventionDrug: PEG-L-asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Drug: daunoxome
Drug: fludarabine
Radiation: Radiation Therapy
PhasePhase 3
SponsorUniversity of Schleswig-Holstein
Responsible PartyUniversity of Schleswig-Holstein
ClinicalTrials.gov IdentifierNCT01117441
First ReceivedMay 3, 2010
Last UpdatedAugust 15, 2013
Last verifiedAugust 2013

Tracking Information[ + expand ][ + ]

First Received DateMay 3, 2010
Last Updated DateAugust 15, 2013
Start DateJune 2010
Estimated Primary Completion DateMay 2020
Current Primary Outcome Measures
  • Event-free survival [Time Frame: 10 years from the start of recruitment] [Designated as safety issue: No]Randomization R1: Event-free survival from time of randomization
    Historical comparison non-HR T-ALL: Event-free survival from diagnosis
    Historical comparison "MRD Non-Responders": Event-free survival from start of DNX-FLA (morphological non-response after HR-3' is no event for this study question)
  • Disease-free survival [Time Frame: 10 years from the start of recruitment] [Designated as safety issue: No]Randomization R2: Disease-free survival from time of randomization
    Historical comparison SR: Disease-free survival from start of Protocol M
  • minimal residual disease (MRD) [Time Frame: week 12 of treatment] [Designated as safety issue: No]Randomization RHR: rate of MRD highly positive patients (MRD ≥ 10-3) at TP2 (week 12)
Current Secondary Outcome Measures
  • survival [Time Frame: 10 years from the start of recruitment] [Designated as safety issue: No]All randomized and historical comparisons: Survival
  • treatment-related mortality [Time Frame: up to 25 months from the diagnosis] [Designated as safety issue: Yes]All randomized and historical comparisons: treatment-related mortality in induction or CCR (overall and by chemotherapy/SCT)
  • adverse events [Time Frame: up to 25 months from the diagnosis] [Designated as safety issue: Yes]All randomized and historical comparisons: incidence and frequency of adverse events of interest and serious adverse events
  • event-free survival [Time Frame: 10 years from the start of recruitment] [Designated as safety issue: No]Randomization R-HR: Event-free survival from time of randomization
  • minimal residual disease [Time Frame: after 24 weeks of treatment] [Designated as safety issue: No]"MRD Non-Responders": MRD levels after DNX-FLA

Descriptive Information[ + expand ][ + ]

Brief TitleInternational Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia
Official TitleInternational Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia
Brief Summary
Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of
cancer cells, either by killing the cells or by stopping them from dividing. Giving more
than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known
which combination chemotherapy regimen is more effective in treating young patients with
acute lymphoblastic leukemia (ALL).

This trial is studying several different combination chemotherapy regimens to compare how
well they work in treating young patients with ALL.

Study objectives

Primary study questions:

- Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or
unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone
marrow on day 15 <0.1% or with TEL/AML1-positive ALL (randomized study question R1):
Can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior
EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)?

- Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2):
Can the clinical outcome be improved by protracted asparagine depletion achieved
through application of intensified PEG-L-asparaginase during reintensification and
early maintenance?

- High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can
the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during
Protocol IB?

Secondary study questions:

- Standard risk (SR) patients identified by at least one sensitive marker: Is the
clinical outcome comparable to that obtained in SR patients (identified with two
sensitive markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the
use of PEG-L-asparaginase instead of native E. coli L-ASP?

- T-ALL non-HR patients: Can the high level of outcome which was obtained for these
patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of
PEG-L-ASP instead of native E. coli L-ASP?

- HR patients with persisting high MRD levels despite the use of the HR blocks in the
intensified consolidation phase "MRD Non-Responders": Is it possible to improve the
outcome and to achieve a further reduction of leukemic cell burden by administration of
an innovative treatment schedule (DNX-FLA)?

- Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are
asparaginase activity and asparaginase antibodies associated with development of
allergic reactions, and do they have an effect on the outcome of the patients?

- What is the relative value of different methods of MRD monitoring in the definition of
alternative stratification systems within a BFM-oriented protocol?
Detailed Description
Risk Stratification

- T/non-HR: T-ALL in absence of any HR criteria (see below)

- pB/non-HR: pB-ALL in absence of any HR criteria (see below).

- SR (polymerase chain reaction(PCR)-MRD-SR (MRD-negative on day 33 and 78) or, if
no PCR-MRD result available, FCM d15 < 0.1%)

- MR (no SR)

- HR: Prednisone poor-response (≥1000 blast cells/µl in peripheral blood on day 8), blast
cells ≥10% in bone marrow on day 15 as measured by FCM, non-remission on day 33,
positivity for MLL/AF4 or t(4;11), hypodiploidy (< 45 chromosomes), PCR-MRD-HR (MRD
≥10E-3 on day 78) or PCR-MRD-MR SER (only in pB-ALL, MRD ≥ 10-3 on day 33 and MRD
positive at a level of < 10E-3 on day 78)

Chemotherapy

According to the risk group, patients receive the following chemotherapy elements:

T/non-HR: Protocol I, Protocol M, Protocol II and Maintenance pB/non-HR: Protocol I,
Protocol M, Protocol II and Maintenance HR: Protocol I, HR-1', HR-2', HR-3', 3x Protocol
III, Maintenance Patients of the HR group with PCR-MRD ≥10E-3 after element HR-3' are
eligible for treatment with element DNX-FLA.

Protocol I Cytoreductive prephase: Prednisone (PDN) on days 1-7 and one dose of methotrexate
(MTX) intrathecal (IT) on day 1 Protocol IA: Prednisone (PDN) on days 8 to 28 (21 days);
vincristine (VCR) on days 8, 15, 22, 29 (4 doses); daunorubicin (DNR) on days 8, 15, 22 and
29 (4 doses); pegylated L-asparaginase (PEG-L-ASP) on days 12 and 26; MTX IT on days 12 and
33 and in case of blast cells in cerebrospinal fluid at diagnosis additional IT MTX is given
on days 19 and 26.

Protocol IA': Only two doses of DNR on days 8 and 15 given to patients eligible for
randomization R1 and randomized into the experimental arm Protocol IA-CPM: additional
cyclophosphamide (CPM) on day 10 only in T-ALL patients with prednisone poor-response
Protocol IA-Dexa (IAD): Dexamethasone (DXM) instead of PDN is given to all patients with
T-ALL without any high-risk criteria as identified by day 8.

Protocol IB: CPM on days 36 and 64; cytarabine (ARA-C) on days 38-41, 45-48, 52-55 and
59-62; 6-mercaptopurine (6-MP) on days 36 to 63 (28 days); MTX IT on day 45 and 59 Protocol
IB-ASP+: additional PEG-L-ASP on days 40, 47, 54, and 61 (4 doses) are given to the patients
eligible for randomization RHR and randomized into the experimental arm.

Protocol M 6-MP on days 1- 56, high-dose MTX (HD-MTX) on days 8, 22, 36, 50 and MTX IT on
days 8, 22, 36 and 50 Protocol II Protocol IIA: DXM on days 1 to 21 (21 days); VCR on days
8, 15, 22, 29 (4 doses); doxorubicine (DOX) on days 8, 15, 22 and 29 (4 doses); PEG-L-ASP on
day 8 (1 dose); MTX IT on days 1 and 18 only in patients with initial CNS involvement.

Protocol IIA-ASP+: additional PEG-L-ASP on day 22 for patients eligible for randomization R2
and randomized into the experimental arm.

Protocol IIB: CPM on day 36; ARA-C on days 38-41 and 45-48; thioguanine (TG) on days 36 to
49 (14 days) and MTX IT on days 38 and 45.

Protocol IIB-ASP+: additional PEG-L-ASP on days 36 and 50 for eligible for randomization R2
and randomized into the experimental arm.

Protocol III DXM on days 1-15; VCR on days 1 and 8; DOX on days 1 and 8; PEG-L-ASP on day 1;
CPM on day 15; ARA-C on days 17-20 and 24-27; TG on days 15 - 28 and MTX IT on days 17 and
24, also on day 1 in patients with initial CNS involvement HR-1' DXM on days 1-5; VCR on
days 1 and 6; HD-MTX on day 1; CPM every 12 hours on days 2-4 (5 doses); HD-ARA-C every 12
hours on day 5 (2 doses); PEG-L-ASP on day 6, MTX IT on day 1 HR-2' DXM on days 1 to 5; VDS
on days 1 and 6; HD-MTX on day 1; IFO every 12 hours on days 2-4 (5 doses); DNR on day 5;
PEG-L-ASP on day 6; MTX IT on day 1 and 1 in patients with initial CNS involvement also day
5 HR-3' DXM on days 1-5; ARA-C 4 x on days 1-2 in 12 h intervals; etoposide (VP-16) every
12 hours on days 3-5 (5 doses); PEG-L-ASP on day 6; MTX IT on day 1 DNX-FLA Flucytosine
(FLU) on days 1-5 (5 doses); HD-ARA-C on days 1 to 5 (5 doses); liposomal daunorubicin (DNX)
on days 1, 3 and 5 (3 doses); MTX IT on day 1

Interim/Maintenance (until week 104):

6-MP p.o. daily; MTX p.o. once a week, doses adjusted to white blood cell count; PEG-L-ASP:
every second week (6 doses), only for patients eligible for randomization R2 and randomized
into the experimental arm; MTX IT every 6 weeks up to a total of 6 doses for the following
subgroups (all CNS-negative):

- T-ALL (HR or non-HR) with < 2 years of age at start of maintenance,

- T-ALL, non-HR and initial WBC < 100 000/μl

- pB-ALL with PPR and/or FCM-MRD day 15 ≥ 10 % and/or PCR-MRDMR SER as only HR criteria

Radiotherapy Patients without CNS involvement and

- T-ALL/non-HR, WBC ≥ 100 000/μl, and age ≥ 2 years at start of pCRT or

- with risk group HR and age ≥ 2 years at start of pCRT except pB-ALL with PPR and/or
FCM-MRD day 15 ≥ 10 % and/or PCR-MRD-MR SER as only HR criteria receive preventive
cranial radiotherapy with 12 Gy

Patients with CNS involvement receive therapeutic cranial radiotherapy with 18 Gy (age 1 to
<2 years 12 Gy).
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionLeukemia
InterventionDrug: PEG-L-asparaginase
see detailed protocol description
Other Names:
Oncaspar medacDrug: cyclophosphamide
see detailed protocol description
Drug: cytarabine
see detailed protocol description
Drug: daunorubicin hydrochloride
see detailed protocol description
Drug: dexamethasone
see detailed protocol description
Drug: doxorubicin hydrochloride
see detailed protocol description
Drug: etoposide
see detailed protocol description
Drug: ifosfamide
see detailed protocol description
Drug: mercaptopurine
see detailed protocol description
Drug: methotrexate
see detailed protocol description
Drug: prednisone
see detailed protocol description
Drug: thioguanine
see detailed protocol description
Drug: vincristine sulfate
see detailed protocol description
Drug: vindesine
see detailed protocol description
Drug: daunoxome
see detailed protocol description; only given by patients with poor MRD-response during the high risk treatment
Drug: fludarabine
see detailed protocol description; only given by patients with poor MRD-response during the high risk treatment
Radiation: Radiation Therapy
for eligibility for radiotherapy see detailed protocol description
Study Arm (s)
  • Active Comparator: R1 control arm
    see detailed protocol description
  • Experimental: R1 experimental arm
    see detailed protocol description
  • Active Comparator: R2 control arm
    see detailed protocol description
  • Experimental: R2 experimental arm
    see detailed protocol description
  • Active Comparator: R-HR control arm
    see detailed protocol description
  • Experimental: R-HR experimental arm
    see detailed protocol description

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment4750
Estimated Completion DateMay 2020
Estimated Primary Completion DateMay 2020
Eligibility Criteria
Inclusion Criteria:

- newly diagnosed acute lymphoblastic leukemia

- age ≥ 1 year (> 365 days) and < 18 years old (up to 17 years old and 365 days)

- no Ph+ (BCR/ABL or t(9;22)-positive) ALL

- no evidence of pregnancy or lactation period

- no participation in another clinical study

- patient enrolled in a participating center

- written informed consent

Exclusion Criteria:

- pre-treatment with cytostatic drugs

- pre-treatment with cytostatic drugs

- steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month
before diagnosis

- treatment started according to another protocol

- underlying diseases that prohibit treatment according to the protocol

- ALL diagnosed as second malignancy steroid pre-treatment with ≥ 1 mg/kg/d for more
than two weeks during the last month before diagnosis
GenderBoth
Ages1 Year
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesAustralia, Austria, Czech Republic, Germany, Israel, Italy, Switzerland

Administrative Information[ + expand ][ + ]

NCT Number NCT01117441
Other Study ID NumbersAIEOP-BFM ALL 2009
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of Schleswig-Holstein
Study SponsorUniversity of Schleswig-Holstein
CollaboratorsDeutsche Krebshilfe e.V., Bonn (Germany)
SIGMA TAU RARE DISEASES, S.A.
medac GmbH
Investigators Principal Investigator: Martin Schrappe, MD PhD Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel
Verification DateAugust 2013

Locations[ + expand ][ + ]

The Sydney Children's Hospital, Centre for Children's Cancer and Blood Disorders
Randwick, Australia, NSW 2031
Contact: Draga Barbaric | +61 2 93821111 | Draga.Barbaric@SESIAHS.HEALTH.NSW.GOV.AU
Recruiting
The Children's Hospital at Westmead, Department of Oncology
Westmead, Australia, NSW 2145
Contact: Luciano Dalla-Pozza | +61 2 98450000 | luced@chw.edu.au
Recruiting
Krankenhaus Dornbirn, Abt. für Kinder- und Jugendheilkunde
Dornbirn, Austria, 6850
Contact: Bernd Ausserer | +43 55723032301
Recruiting
Univ.-Kinderklinik Graz, Abt. Pädiatrische Hämato-Onkologie
Graz, Austria, 8036
Contact: Christian Urban | +43 3163853485
Recruiting
Department f. Kinder- u. Jugendheilkunde, Universitätsklinik f. Pädiatrie II
Innsbruck, Austria, 6020
Contact: Bernhard Meister | +43 51250481570
Recruiting
A.oe. Landeskrankenhaus Klagenfurt, Abt. für Kinder- und Jugendheilkunde
Klagenfurt, Austria, 9026
Contact: Wilhelm Kaulfersch | +43 4635380
Recruiting
A.oe. Landeskrankenhaus Leoben, Abt. für Kinder und Jugendliche
Leoben, Austria, 8700
Contact: Reinhold Kerbl | +43 38424012438
Recruiting
Landes-Kinderklinik Linz, Haematologie/Onkologie
Linz, Austria, 4020
Contact: Klaus Schmitt | +43 73269230
Recruiting
St. Johanns Spital / Landeskrankenhaus, Salzburg, Kinderspital Abt. Kinder u. Jugendheilkunde
Salzburg, Austria, 5020
Contact: Wolfgang Sperl | +43 66144822690
Recruiting
St. Anna Kinderspital, Zentrum für Kinder- und Jugendheilkunde
Wien, Austria, 1090
Contact: Georg Mann | +43 140470 0
Recruiting
University Hospital Brno, Department of Pediatric Oncology
Brno, Czech Republic, 662 63
Contact: Jaroslav Štěrba | +42 532234755 | jsterb@fnbrno.cz
Recruiting
University Hospital Hradec Králové, Department of Pediatrics
Hradec Králové, Czech Republic, 500 12
Contact: Jiří Hak | +42 495831111 | j.hak@seznam.cz
Recruiting
University Hospital Olomouc, Department of Pediatrics
Olomouc, Czech Republic, 770 00
Contact: Vladimir Mihál | +42 585412736 | mihalv@fnol.cz
Recruiting
Teaching Hospital Ostrava-Poruba, Department of Pediatrics
Ostrava-Poruba, Czech Republic, 708 52
Contact: Bohumir Blažek | +42 5973736312 | bohumir.blazek@fspo.cz
Recruiting
University Hospital Plzeň, Department of Pediatrics
Plzeň, Czech Republic, 304 60
Contact: Zdena Černá | +42 377402431 | cernaz@fnplzen.cz
Recruiting
University Hospital Motol, Department of Pediatric Hematology and Oncology
Praha 5, Czech Republic, 150 06
Contact: Jan Starý | +42 224436401 | jan.stary@lfmotol.cuni.cz
Recruiting
Masaryk´s Hospital Ústí nad Labem, Department of Pediatrics
Ústí nad Labem, Czech Republic, 401 13
Contact: Daniela Procházková | +42 475681111 | daniela.prochazkova@mnul.cz
Recruiting
Regional Hospital České Budějovice, Department of Pediatrics
České Budějovice, Czech Republic, 370 01
Contact: Pavel Timr | +42 387871111 | timr@nemcb.cz
Recruiting
Kinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/Onkologie
Aachen, Germany, 52074
Contact: Rolf Mertens | +49 2418089902 | rmertens@ukaachen.de
Recruiting
I. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ Onkologie
Augsburg, Germany, 86156
Contact: Astrid Gnekow | +49 8214003631 | gnekow.hit-lgg@klinkum-augsburg.de
Recruiting
Klinikum Bayreuth, Kinderklinik
Bayreuth, Germany, 95445
Contact: Thomas Rupprecht | +49 9214006200 | thomas.rupprecht@klinikum-bayreuth.de
Recruiting
Kinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: Kinderhämatologie
Berlin, Germany, 13353
Contact: Arend Stackelberg | +49 30450566833 | arend.stackelberg@charite.de
Recruiting
Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. Pädiatrie
Berlin, Germany, 13125
Contact: Lothar Schweigerer | +49 3094012367 | lschweigerer@berlin.helio-kliniken.de
Recruiting
Zentrum für Kinderheilkunde der Universität Bonn, Päd. Hämatologie / Onkologie
Bonn, Germany, 53113
Contact: Gudrun Fleischhack | +49 22828733215 | gudrun.fleischhack@ukb.uni-bonn.de
Recruiting
Städtisches Krankenhaus, Kinderklinik
Braunschweig, Germany, 38118
Contact: Wolfgang Eberl | +49 5315951424 | w.eberl@klinkum-braunschweig.de
Recruiting
Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / Onkologie
Chemnitz, Germany, 09009
Contact: Andre Hofmann | +49 37133324287 | a.hofmann@skc.de
Recruiting
Carl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/Onkologie
Cottbus, Germany, 03048
Contact: Elisabeth Holfeld | +49 355462332 | e.holfeld@ctk.de
Recruiting
Vestische Kinder- u. Jugendklinik, Universitätsklinik Witten/Herdecke
Datteln, Germany, 45711
Contact: Thomas Wiesel | +49 2363975846 | th.wiesel@kinderklinik-datteln.de
Recruiting
Klinikum Lippe-Detmold, Kinder- und Jugendmedizin
Detmold, Germany, 32756
Contact: Hans Broede | +49 5231724511 | hans.broede@klinikum-lippe.de
Recruiting
Klinikum Dortmund, Klinik f. Kinder- und Jugendmedizin
Dortmund, Germany, 44137
Contact: Dominik Schneider | +49 23195321050 | dominik.schneider@klinikumdo.de
Recruiting
Uni.Klinik Carl Gustav Carus, Klinik f. Kinderheilkunde
Dresden, Germany, 01307
Contact: Meinolf Suttorp | +49 3514583522 | meinolf.suttorp@uniklinkum-dresden.de
Recruiting
Universitätskinderklinik
Düsseldorf, Germany, 40225
Contact: Arndt Borkhardt, Prof. | Arndt.Borkhardt@med.uni-duesseldorf.de
Principal Investigator: Arndt Borkhardt, Prof.
Recruiting
Helios Klinikum Erfurt GmbH, Klinik für Kinderheilkunde
Erfurt, Germany, 99089
Contact: Axel Sauerbrey | +49 361784501 | axel.sauerbrey@helios-kliniken.de
Recruiting
Universitätsklinikum Erlangen, Kinder- und Jugendmedizin, Abt. für Onkologie/ Hämatologie/Immunologie
Erlangen, Germany, 91054
Contact: Wolfgang Holter | +49 91318534759 | wolfgang.holter@uk-erlangen.de
Recruiting
Universitätsklinikum Essen, Kinderklinik, Hämatologie/Onkologie
Essen, Germany, 45122
Contact: Angelika Eggert | +49 2017233755 | angelika.eggert@ukuk-essen.de
Recruiting
Universitäts-Kinderklinik, Klinik für Kinderheilkunde III, Pädiatrische Hämatologie/Onkologie
Frankfurt, Germany, 60590
Contact: Thomas Klingebiel | +49 6963015094 | thomas.klingebiel@kgu.de
Recruiting
Universitäts-Kinderklinik, Haematologie/ Onkologie
Freiburg, Germany, 79106
Contact: Charlotte Niemeyer | +49 7612704505 | zkj-onkpaed@uniklinik-freiburg.de
Recruiting
Klinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/Onkologie
Gießen, Germany, 35385
Contact: Alfred Reiter | +49 6419943420 | alfred.reiter@paediat.med.uni-giessen.de
Recruiting
Klinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und Hämatologie
Greifswald, Germany, 17475
Contact: Holger Lode | +49 3834866325 | holger.lode@uni-greifswald.de
Recruiting
Universitäts-Kinderklinik Päd. I, Hämatologie/Onkologie
Göttingen, Germany, 37099
Contact: Max Lakomek | +49 551396201 | lakomek@med.uni-goettingen.de
Recruiting
Uniklinikum d. Martin Luther Universität, Halle Wittenberg, Univ.-und Poliklinik für Kinder- und Jugendmedizin
Halle, Germany, 06120
Contact: Dieter Körholz | +49 3455573257 | dieter.koerholz@medizin.uni-halle.de
Recruiting
Medizinische Hochschule Hannover, Zentrum Kinderheilkunde u. Jugendmedizin
Hannover, Germany, 30625
Contact: Christoph Klein | +49 5115326710 | klein.christoph@mh-hannover.de
Recruiting
Universitäts-Kinderklinik, Päd. Onkologie, Hämatologie, und Immunologie
Heidelberg, Germany, 69120
Contact: Wolfgang Behnisch | +49 6221564555 | wolfgang.behnisch@med.uni-heidelberg.de
Recruiting
Klinikum Heilbronn GmbH, Klinik für Kinderheilkunde und Jugendmedizin/Perinatalzentrum
Heilbronn, Germany, 74078
Contact: Hermann Full | +49 7131493702 | hermann.full@slk-kliniken.de
Recruiting
Gemeinschaftskrankenhaus Herdecke, Kinderabteilung
Herdecke, Germany, 58313
Contact: Alfred Längler | +49 2330623893 | a.laengler@gemeinschaftskrankenhaus.de
Recruiting
Universitätsklinik für, Kinder- und Jugendmedizin, Päd. Hämatologie/ Onkologie
Homburg / Saar, Germany, 66421
Contact: Norbert Graf | +49 68411628397 | graf@uks.eu
Recruiting
Klinikum, der Friedrich-Schiller-Universität, Klinik für Kinder- und Jugendmedizin
Jena, Germany, 7740
Contact: Bernd Gruhn | +49 3641938220 | bernd.gruhn@med.uni-jena.de
Recruiting
Städtisches Klinikum Karlsruhe, Kinderklinik
Karlsruhe, Germany, 76133
Contact: Alfred Leipold | +49 7219740 | alfred-leipold@klinikum-karlsruhe.de
Recruiting
Klinikum Kassel, Kinderklinik
Kassel, Germany, 34125
Contact: Michaela Nathrath | +49 5619803382 | michaela.nathrath@klinikum-kassel.de
Recruiting
Klinik für Allgemeine Paediatrie, Univ.-Klinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Contact: Martin Schrappe | +49 4315971620 | m.schrappe@pediatrics.uni-kiel.de
Recruiting
Städtisches Krankenhaus Kemperhof, Kinderklinik
Koblenz, Germany, 56073
Contact: Rudolf Ferrari | +49 2614992602 | rudolf.ferrari@rz-online.de
Recruiting
Kliniken der Stadt Köln GmbH, Kinderkrankenhaus Riehl
Köln, Germany, 50735
Contact: Aram Prokop | +49 22189075158 | prokopa@klinken-koeln.de
Recruiting
Med. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische Station
Köln, Germany, 50937
Contact: Frank Berthold | +49 2214784380 | frank.berthold@uk-koeln.de
Recruiting
Universität zu Lübeck, Klinik für Kinder- u. Jugendmedizin, Abt. Hämatologie/ Onkologie/Immunologie
Lübeck, Germany, 23538
Contact: Melchior Lauten | +49 4515002557 | lauten@paedia.ukl.mu-luebeck.de
Recruiting
Universitätsklinikum Magdeburg, Klinik für Päd. Hämatologie/Onkologie
Magdeburg, Germany, 39120
Contact: Peter Vorwerk | +49 3916717210 | peter.vorwerk@med.ovgu.de
Recruiting
Klinikum Mannheim gGmbH, Kinderklinik, Abt. Hämatologie/Onkologie
Mannheim, Germany, 68167
Contact: Matthias Dürken | +49 6213832244 | matthias.duerken@kikli.ma.uni-heidelberg.de
Recruiting
Universitätskliniken, Giessen und Marburg GmbH
Marburg, Germany, 35033
Contact: Barbara Schütz | +49 64212862671 | barbara.schuetz@med.uni-marburg.de
Recruiting
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Contact: Bernhard Erdlenbruch | +49 5718010 | bernhard.erdlenbruch@klinikum-minden.de
Recruiting
Städt. Krankenhaus München GmbH, Krankenhaus München-Schwabingen, Kinderklinik d. TU
München, Germany, 80804
Contact: Angela Wawer | +49 8930682261 | angela.wawer@lrz.tum.de
Recruiting
Universitäts-Kinderklinik, Päd. Hämatologie und Onkologie
Münster, Germany, 48149
Contact: Heribert Jürgens | +49 2518347742 | jurgh@uni-muenster.de
Recruiting
Cnopf'sche Kinderklinik, Onkologie
Nürnberg, Germany, 90419
Contact: Wolfram Scheurlen | +49 9113340323 | wolfram.scheurlen@diakonieneudettelsau.de
Recruiting
Klinikum Oldenburg gGmbH, Zentrum für Kinder- u. Jugendmedizin, (Elisabeth Kinderkrankenhaus)
Oldenburg, Germany, 26133
Contact: Hermann Müller | +49 4414032013 | mueller.hermann@klinikum-oldenburg.de
Recruiting
Universitäts-Kinderklinik
Rostock, Germany, 18055
Contact: Carl-Friedrich Classen | +49 3814947000 | carl-friedrich.classen@med.uni-rostock.de
Recruiting
Asklepios-Klinik, Sankt Augustin GmbH
Sankt Augustin, Germany, 53757
Contact: Harald Reinhard | +49 2241249304 | h.reinhard@asklepios.com
Recruiting
HELIOS Kliniken Schwerin, Klinik f. Kinder-u. Jugendmedizin
Schwerin, Germany, 19049
Contact: Matthias Kasbohm | +49 3855202710 | matthias.kasbohm@helios-kliniken.de
Recruiting
Deutsches Rotes Kreuz, Kinderklinik
Siegen, Germany, 57072
Contact: Ulrich Leuthold | +49 27123450 | ulrich.leuthold@dvk-kinderklinik.de
Recruiting
Olga-Hospital, Kinderklinik, Pädiatrisches Zentrum, Abt. Hämatologie/Onkologie
Stuttgart, Germany, 70176
Contact: Stefan Bielack | +49 7119922461 | st.bielack@olgahospital.de
Recruiting
Krankenanstalt Trier, Mutterhaus der Borromaeerinnen, Pädiatrische Abteilung
Trier, Germany, 54290
Contact: Stefan Weis | +49 6519472654 | weis@mutterhaus.de
Recruiting
Universitäts-Kinderklinik, Abt. Kinderheilkunde II, Hämatologie/Onkologie
Tübingen, Germany, 72076
Contact: Hans-Gerhard Scheel-Walter | +49 70712984744 | hans-gerhard.scheel-waler@med.uni-tuebingen.de
Recruiting
Universitäts-Kinderklinik
Ulm, Germany, 89075
Contact: Klaus-Michael Debatin | +49 7315000 | klaus-michael.debatin@uni-ulm.de
Recruiting
Stadtkrankenhaus, Kinderklinik
Wolfsburg, Germany, 38440
Contact: Sally Mukodzi | +49 53618000 | sally.mukidzi@klinikum-wolfsburg.de
Recruiting
Universitäts-Kinderklinik
Würzburg, Germany, 97080
Contact: Paul- Gerhardt Schlegel | +49 93120127856 | schlegel@mail.uni-wuerzburg.de
Recruiting
HaEmek Medical Center
Afula, Israel, 18101
Contact: Gabriel Hertzel | +972 46494000 | gabriel_h@clalit.org.il
Recruiting
Soroka Medical Center
Beer-Sheva, Israel, 84101
Contact: Joseph Kapelushnik | +972 86403963 | JosephK2@clalit.org.il
Recruiting
Bnai-Zion Medical Center
Haifa, Israel, 33394
Contact: Dina Attias | +972 48359359 | attias_o@inter.net.il
Recruiting
Rambam Medical Center
Haifa, Israel, 31096
Contact: Nira Arad-Cohen | +972 48543111 | n_arad-cohen@rambam.health.gov.il
Recruiting
Hadassah University Medical Center
Jerusalem, Israel, 91120
Contact: Michael Weintraub | +972 6777111 | michaelw@hadassah.org.il
Recruiting
Schneider Children Medical Center of Israel
Petach Tikva, Israel, 49202
Contact: Sarah Elitzur | +972 39253253 | Sarhae@clalit.org.il
Recruiting
Dana children hospital
Tel-Aviv, Israel, 64239
Contact: Ronit Elhasid | +972 036974504 | ronite@tasmc.health.gov.il
Recruiting
Sheba Medical Center
Tel-Hashomer, Israel
Contact: Bella Bielorai | +972 526666357 | bellab@sheba.health.gov.il
Recruiting
Centro Regionale Oncoematologia Pediatrica Ospedale dei Bambini "G. Salesi" Clinica Pediatrica
Ancona, Italy, 60123
Contact: Paolo Pierani | +39 71596236036/363 | paolopierani@libero.it
Recruiting
Dipartimento Biomedicina Età Evolutiva U.O Pediatrica I Policlinico
Bari, Italy, 70124
Contact: Domenico De Mattia | +39 805592285 | demattia@bioetaev.uniba.it
Recruiting
U.O.C. Pediatria e Patologia Neonatale Ospedale San Martino
Belluno, Italy, 32100
Contact: Luigi Memo | +39 437516231 | luigi.memo@ulss.belluno.it
Recruiting
U.O. Pediatrica - OO.RR Bergamo
Bergamo, Italy, 24100
Contact: Valentino Conter | +39 35269294/77 | pedematonco@ospedaliriuniti.bergamo.it
Recruiting
Istituto Ortopedico Rizzoli Sez. di chemioterapia dei tumori dell'apparato locomotore
Bologna, Italy, 40136
Contact: Massimo Eraldo Abate | +39 516366829107 | massimo.abate@ior.it
Recruiting
Oncologia ed Ematologia "Lalla Seràgnoli" Clinica Pediatrica Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
Contact: Andrea Pession | +39 51346044 | andrea.pession@unibo.it
Recruiting
Pediatria Ospedale Regionale
Bolzano, Italy, 39100
Contact: Laura Battisti | +39 471908648 | Laura.battisti@asbz.it
Recruiting
Clinica Pediatrica Oncoematologia pediatrica e TMO Ospedale dei Bambini
Brescia, Italy, 25123
Contact: Fulvio Porta | +39 303995715 | fulvio.porta@gmail.com
Recruiting
Istituto di Clinica Pediatrica Ospedale Regionale per le Microcitemie
Cagliari, Italy, 09121
Contact: Roberto Targhetta | 39 706095646512 | oncoematologia@tiscali.it
Recruiting
Divisione Ematologia - Oncologia Pediatrica Clinica Pediatrica
Catania, Italy, 95123
Contact: Santo Marino | +39 953782497 | smarino@unict.it
Recruiting
Unità Operativa di Ematologia ed Oncologia Pediatrica Az. Osp. "Pugliese-Ciaccio"
Catanzaro, Italy, 88100
Contact: Caterina Consarino | +39 961883105 | cconsar@tin.it
Recruiting
Unità Operativa Pediatria Azienda Ospedaliera Annuziata
Cosenza, Italy, 87100
Contact: Domenico Sperlì | +39 984681315 | d.sperli@virgilio.it
Recruiting
Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria Università di Ferrara
Ferrara, Italy, 41100
Contact: Caterina Borgna Pignatti | +39 532236856 | c.borgna@unife.it
Recruiting
Dipartimento A.I. Oncoematologia Pediatrica e Cure Domiciliari U.O. Oncoematologia Pediatrica Azienda Ospedaliero-Universitaria Meyer
Firenze, Italy, 50139
Contact: Maurizio Aricò | +39 55566248924/16 | m.arico@meyer.it
Recruiting
Dipartimento di Ematologia e Oncologia Pediatrica Instituto " G. Gaslini"
Genova Quarto, Italy, 16148
Contact: Giorgio Dini | +39 105636715 | giorgiodini@ospedale-gaslini.ge.it
Recruiting
Ospedale "Vito Fazzi" U.O. di Pediatria
Lecce, Italy, 73100
Contact: Silvio Pozzi | +39 832661437 | pedia@vitofazzi.lecce.it
Recruiting
Unità di Ricerca Clinica Pediatrica HSR TIGET - Istituto Scientifico San Raffaele
Milano, Italy, 20132
Contact: Maria Grazia Roncarolo | +39 226434875 | roncarolo.mariagrazia@hsr.it
Recruiting
Divisione Pediatria "Mariani" Ospedale "Niguarda Ca' Granda"
Milano, Italy, 20162
Contact: Fausto Fedeli | +39 264442363 | fausto.fedeli@ospedaleniguarda.it
Recruiting
Clinica Pediatrica II De Marchi
Milano, Italy, 20122
Contact: Vittorio Carnelli | +39 257992454 | carnelli@unimi.it
Recruiting
Divisione di Oncologia Pediatrica Ist. Nazionale Studio e Cura Tumori
Milano, Italy, 20133
Contact: Maura Massimino | +39 223902593 | maura.massimino@istitutotumori.mi.it
Recruiting
U.O. di Ematologia, oncologia e trapianto Azienda Policlinico di Modena
Modena, Italy, 41100
Contact: Paolo Paolucci | +39 594222535448/ 52837 | paolucci.paolo@unimo.it
Recruiting
Clinica Pediatrica dell'Università Milano - Bicocca A.O. San Gerardo - Fondazione MBBM
Monza, Italy, 20052
Contact: Andrea Biondi | +39 392333513 | segreteriadirezionecp@fondazionembbm.it
Recruiting
Servizio di Oncologia Pediatrica Dipartimento di Pediatria Seconda Università degli Studi di Napoli
Napoli, Italy, 80138
Contact: Fiorina Casale | +39 815665412438 | fiorina.casale@unina2.it
Recruiting
Dipartimento di Oncologia A.O. Santobono - Pausilipon
Napoli, Italy, 80123
Contact: Vincenzo Poggi | +39 812205410 | vinpog@iol.it
Recruiting
A.O. "A. Cardarelli", U.O.S. Talassemia pediatrica ed emoglobinopatie pediatriche
Napoli, Italy, 80131
Contact: Aldo Filosa | +39 817472702 | aldo.filosa@ospedalecardarelli.it
Recruiting
U.O.C. Pediatria - TIN, Ospedale "Umberto Primo" ASL SA - 1
Nocera Inferiore - SA, Italy, 84014
Contact: Giovanni Amendola | +39 819213006 | dott.amendola@alice.it
Recruiting
S.C.D.U. Azienda Ospedaliera "Maggiore della carità"
Novara, Italy, 28100
Contact: Gianni Bona | +39 3213733474 | mara.berta@unito.it
Recruiting
Dipartimento di Pediatria Università di Padova Cattedra Di Oncoematologia Pediatrica
Padova, Italy, 35128
Contact: Modesto Carli | +39 498213579 | modesto.carli@unipd.it
Recruiting
Oncoematologia Pediatrica Ospedale dei Bambini G. di Cristina
Palermo, Italy, 90134
Contact: Paolo D'Angelo | +39 916666131130 | oncoematoped@ospedalecivicopa.org
Recruiting
U.O. di Pediatria e Oncoematologia Pediatrica Az. Osp. Di Parma Ospedali Riuniti
Parma, Italy, 43100
Contact: Giancarlo Izzi | +39 521702223 | gcizzi@ao.pr.it
Recruiting
Oncoematologia Pediatrica IRCCS, Policlinico San Matteo
Pavia, Italy, 27100
Contact: Franco Locatelli | +39 382502607 | f.locatelli@smatteo.pv.it
Recruiting
S.C. di Oncoematologia Pediatrica con Trapianto di CSE, Ospedale "S.M. della Misericordia" A.O. Perugia
Perugia, Italy, 06156
Contact: Franco Aversa | +39 755782202 | pediatria.silv@ospedale.perugia.it
Recruiting
U.O. Pediatrica Azienda Ospedaliera San Salvatore
Pesaro, Italy, 61100
Contact: Leonardo Felici | +39 721362459 | l.felici@ospedalesansalvatore.it
Recruiting
Ematologia, Ospedale di Muraglia
Pesaro, Italy, 61100
Contact: Giuseppe Visani | +39 721364039 | g.visani@ospedalesansalvatore.it
Recruiting
Dipartimento di Ematologia Ospedale Civile
Pescara, Italy, 65123
Contact: Giuseppe Fioritoni | +39 854252467 | aieop.pescara@gmail.com
Recruiting
Centro di Oncoematologia Pediatrica e Trapianto Midollo Osseo Azienda Ospedaliero Universitaria Pisana Ospedale S. Chiara
Pisa, Italy, 56126
Contact: Claudio Favre | +39 50992840 | c.favre@clp.med.unipi.it
Recruiting
Centro Integrato di Emato-oncologia e dell'adolescenza A.O. S. Maria degli Angeli - Pordenone e IRCCS Centro di Riferimento Oncologico - Aviano
Pordenone, Italy, 33170
Contact: Maurizio Mascarin | +39 434659536 | mascarin@cro.it
Recruiting
Divisione Ematologia Ospedali Riuniti
Reggio Calabria, Italy, 89100
Contact: Francesco Nobile | +39 965397222397/655 | f.nobile@netonline.it
Recruiting
U.O Pediatria Ospedale Infermi Azienda USL Rimini
Rimini, Italy, 47900
Contact: Vico Vecchi | +39 541705778210 | vvecchi@auslrn.net
Recruiting
Divisione di Ematologia Pediatrica Ospedale "Bambin Gesù"Istituto di Ricerca Scientifica
Roma, Italy, 00165
Contact: Giulio De Rossi | +39 668592129 | g.derossi@opbg.net
Recruiting
Divisione Oncologia Pediatrica Ospedale "Bambin Gesù"
Roma, Italy, 00165
Contact: Giancarlo Isacchi | +39 668592238 | isacchi@opbg.net
Recruiting
Sezione Ematologia Dipart. di biotecnologie Cellulari ed Ematologia Università "La Sapienza"
Roma, Italy, 00161
Contact: Roberto Foà | +39 685795253857951 | rfoa@bce.uniroma1.it
Recruiting
Ospedale Sant'Eugenio clinica pediatrica Univ. Tor Vergata
Roma, Italy, 00144
Contact: Adriana Menichelli | +39 651002309 | menichelliadriana@yahoo.it
Recruiting
Divisione Oncologia Pediatrica Università Cattolica di Roma
Roma, Italy, 00168
Contact: Riccardo Riccardi | +39 63058203 | riccardi@rm.unicatt.it
Recruiting
Oncoematologia pediatrica Università "La Sapienza" Roma
Roma, Italy, 00161
Contact: Manuel Adolfo Castello | +39 649979343 | manuel.castello@uniroma1.it
Recruiting
U.O. Oncoematologia Pediatrica Ospedale "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, Italy, 71013
Contact: Saverio Ladogana | +39 882416250 | ematoncoped@operapadrepio.it
Recruiting
Clinica Pediatrica Università
Sassari, Italy, 07100
Contact: Domenico Gallisai | +39 79228457 | gallisai@uniss.it
Recruiting
Dipartimento di Pediatria Ostetricia e Medicina della Riproduzione Università degli Studi di Siena
Siena, Italy, 53100
Contact: Antonio Acquaviva | +39 577586547583 | acquaviva@unisi.it
Recruiting
Ospedale Infantile Regina Margherita
Torino, Italy, 10126
Contact: Luca Cordero di Montezemolo | +39 113135230
Recruiting
Unità Operativa di Pediatria - U.T.I.N. Az.Osp. "Card. G. Panico"
Tricase, Italy, 73039
Contact: Giuseppe Presta | +39 833544104 | a.civino@piafondazionepanico.it
Recruiting
U.O. Emato-Oncologia Pediatrica Università degli studi di Trieste Ospedale Infantile Burlo Garofolo
Trieste, Italy, 34137
Contact: Paolo Tamaro | +39 403785342309 | tamaro@burlo.trieste.it
Recruiting
SOS Oncologia Pediatrica Policlinico Universitario
Udine, Italy, 33100
Contact: Agostino Nocerino | +39 432559253 | nocerino.agostino@aoud.sanita.fvg.it
Recruiting
Clinica Pediatrica Università degli Studi dell'Insubria di Varese Ospedale "Filippo del Ponte"
Varese, Italy, 21100
Contact: Luigi Nespoli | +39 332299231 | luigi.nespoli@ospedale.varese.it
Recruiting
U.O.C Oncoematologia Pediatrica Policlinico "G.B: Rossi"
Verona, Italy, 37134
Contact: Simone Cesaro | +39 581249316889 | simone.cesaro@azosp.vr.it
Recruiting
Ospedale San Bortolo, U.O. di Pediatria e patologia Neonatale
Vicenza, Italy, 36100
Contact: Paolo Colleselli | +39 444752631 | paolo.colleselli@ulssvicenza.it
Recruiting
Kinderklinik, Hämatologie/Onkologie
Aarau, Switzerland, 5000
Contact: Regula Angst | +41 628384906 | regula.Angst@ksa.ch
Recruiting
Baseler Kinderspital, Hämatologische Poliklinik
Basel, Switzerland, 4005
Contact: Michael Paulussen | +41 616856565
Recruiting
Repartio di Pediatria
Bellinzona, Switzerland, 6500
Contact: Pierluigi Brazzola | +41918118977
Recruiting
Pädiatrische Klinik, Kinderspital Luzern, Kinderonkologie
Luzern, Switzerland, 6000
Contact: Ueli Caflisch | +41 412053172
Recruiting
Hämatologie/Onkologie, Ostschweizer Kinderspital, FMH Pädiatrie, Hämatologie
St. Gallen, Switzerland, 9006
Contact: Jeanette Greiner | +41 712431360 | jeanette.greiner@kispisg.ch
Recruiting
Kinderspital Zürich, Universitäts-Kinderklinik
Zürich, Switzerland, 8032
Contact: Felix Niggli | +41 442667111 | felix.niggli@kispi.unizh.ch
Recruiting