International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
NCT ID: NCT04043494
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
683 participants
INTERVENTIONAL
2019-08-23
2027-11-22
Brief Summary
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* Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)
* Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)
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Detailed Description
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The LBL 2018 trial will be open for the qualified centers of following participating study Groups (core study cohort): AIEOP (Italy), BFM (Austria, Czech Republic, Germany, Switzerland), BSPHO (Belgium), CoALL (Germany), DCOG (The Netherlands), NOPHO (Denmark, Finland, Norway, Sweden), PPLLSG (Poland), SEHOP (Spain) and SFCE (France). HKPHOSG (Hong Kong), HPOG (Hungary), ISPHO (Israel), NSPHO (Moscow), SHOP (Portugal) and SPS (Slovak Republic) start patient recruitment into the extended study cohort (without randomization). Over the trial period study groups may switch from the extended study cohort to the core study cohort.
Primary objectives:
* Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)
* Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)
Patients are stratified into 3 different risk groups according to CNS status, immunophenotype, genetic markers and stage of disease at diagnosis: high risk group (HR), standard risk group I/II (SR I/II) and standard risk group (SR).
Patients in the risk groups SR I/II and SR are randomized (R1) in two arms after a cytoreductive prephase with prednisone. Patients in standard arm receive the standard induction phase with prednisone. Patients in the experimental arm receive an induction phase with dexamethasone instead of prednisone.
In SR group, induction phase is followed by the consolidation phase, the non-HR extra-compartment phase with HD-MTX (high-dose methotrexate), the reintensification phase and the maintenance therapy for the total therapy duration of 24 months. In SR I/II group, patients receive no reintensification phase. The Induction phase is followed by the consolidation phase, the non-HR extra-compartment phase and the maintenance therapy for the total therapy duration of 24 months.
Patients in the HR group are eligible for randomization (R1) as outlined above. In addition high risk patients are eligible for second randomization (R2) at the end of induction phase. In the standard arm, HR-patients receive the consolidation phase and the non-HR extra-compartment phase. In the experimental arm, HR-patients receive a consolidation phase including two additional doses of PEG asparaginase and the HR-intensified extra-compartment phase consisting of two high risk courses alternating with two HD-MTX courses. Either phase is followed by the reintensification phase and the maintenance therapy for the total therapy duration of 24 months.
Patients with involvement of the CNS (CNS positive) are stratified to the high risk group (HR) and are eligible for both randomizations (R1 and R2). Additionally, patients with CNS involvement (CNS positive) receive intensified intrathecal therapy. Intrathecal therapy consists of TIT (triple intrathecal therapy) after diagnosis of CNS involvement. TIT is administered twice weekly until clearance of blasts in the cerebrospinal fluid is achieved. Further intrathecal therapy is provided at the same points of time as for patients without CNS involvement, but TIT instead of MTX IT. In addition, patients receive four additional doses of TIT during maintenance. Cranial irradiation is omitted for patients with CNS involvement.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SR I/II: R1 into protocol Ia-Pred
1. cytoreductive prephase with prednisone
2. standard induction phase (protocol Ia-prednisone)
3. consolidation phase (protocol Ib)
4. non-HR extra-compartment phase (protocol M)
5. maintenance therapy
Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Cytarabine
No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)
Prednisone
Part of standard chemotherapy
Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
SR I/II: R1 into protocol Ia-Dexa
1. cytoreductive prephase with prednisone
2. experimental induction phase (protocol Ia-dexamethasone)
3. consolidation phase (protocol Ib)
4. non-HR extra-compartment Phase (protocol M)
5. maintenance therapy
Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Cytarabine
No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)
Prednisone
Part of standard chemotherapy
Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
SR: R1 into protocol Ia-Pred
1. cytoreductive prephase with prednisone
2. standard induction phase (protocol Ia-prednisone)
3. consolidation phase (protocol Ib)
4. non-HR extra-compartment phase (protocol M)
5. reintensification phase (protocol II)
6. maintenance therapy
Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Cytarabine
No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Doxorubicin
Part of standard chemotherapy
6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)
Prednisone
Part of standard chemotherapy
Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
Thioguanine
Part of standard chemotherapy
Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
SR: R1 into protocol Ia-Dexa
1. cytoreductive prephase with prednisone
2. experimental induction phase (protocol Ia-dexamethasone)
3. consolidation phase (protocol Ib)
4. non-HR extra-compartment phase (protocol M)
5. reintensification phase (protocol II)
6. maintenance therapy
Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Cytarabine
No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Doxorubicin
Part of standard chemotherapy
6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)
Prednisone
Part of standard chemotherapy
Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
Thioguanine
Part of standard chemotherapy
Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
HR: R1 into "Pred" and R2 into non-HR extra-compartment phase
1. cytoreductive prephase with prednisone
2. standard induction phase (protocol Ia-prednisone)
3. consolidation phase (protocol Ib)
4. non-HR extra-compartment phase (protocol M)
5. reintensification phase (protocol II)
6. maintenance therapy
Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Cytarabine
No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Doxorubicin
Part of standard chemotherapy
6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)
Prednisone
Part of standard chemotherapy
Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
Thioguanine
Part of standard chemotherapy
Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase
1. cytoreductive prephase with prednisone
2. experimental induction phase (protocol Ia-dexamethasone)
3. consolidation phase (protocol Ib)
4. non-HR extra-compartment phase (protocol M)
5. reintensification phase (protocol II)
6. maintenance therapy
Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Cytarabine
No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Doxorubicin
Part of standard chemotherapy
6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)
Prednisone
Part of standard chemotherapy
Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
Thioguanine
Part of standard chemotherapy
Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
HR: R1 into "Pred" and R2 into HR extra-compartment phase
1. cytoreductive prephase with prednisone
2. standard induction phase (protocol Ia-prednisone)
3. consolidation phase (protocol Ib\*)
4. HR extra-compartment phase (intensified protocol M)
5. reintensification phase (protocol II)
6. maintenance therapy
Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Cytarabine
No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Doxorubicin
Part of standard chemotherapy
Ifosfamide
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)
Prednisone
Part of standard chemotherapy
Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
Thioguanine
Part of standard chemotherapy
Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Vindesine
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
HR: R1 into "Dexa" and R2 into HR extra-compartment phase
1. cytoreductive prephase with prednisone
2. experimental induction phase (protocol Ia-dexamethasone)
3. consolidation phase (protocol Ib\*)
4. HR extra-compartment phase (intensified protocol M)
5. reintensification phase (protocol II)
6. maintenance therapy
Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Cytarabine
No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Doxorubicin
Part of standard chemotherapy
Ifosfamide
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)
Prednisone
Part of standard chemotherapy
Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
Thioguanine
Part of standard chemotherapy
Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Vindesine
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
Interventions
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Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Cytarabine
No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Doxorubicin
Part of standard chemotherapy
Ifosfamide
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)
Prednisone
Part of standard chemotherapy
Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
Thioguanine
Part of standard chemotherapy
Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Vindesine
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
Eligibility Criteria
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Inclusion Criteria
* age \<18 years
* patient enrolled in a participating center
* written informed consent of patient (\>14 years of age or according to local law and regulation) and parents to trial participation and transfer and processing of data
* willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular) pathology and international pathology panel and/or fresh or fresh frozen samples for genetic risk group stratification if these samples are available after standard diagnostic procedures.
Exclusion Criteria
* non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment, including among others
* prior organ transplant
* severe immunodeficiency
* demyelinating Charcot-Marie Tooth syndrome
* serious acute or chronic infections, such as HIV, VZV and tuberculosis
* urinary tract infection, cystitis, urinary outflow obstruction, severe renal impairment (creatinine clearance less than 20 ml/min)
* severe hepatic impairment (bilirubin \>3 times ULN, transaminases \>10 times ULN)
* myocardial insufficiency, severe arrhythmias
* ulcers of the oral cavity and known active gastrointestinal ulcer disease
* known hypersensitivity to any IMP and to any excipient (listed in section 6.1 of the respective SmPC)
* steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
* vaccination with live vaccines within 2 weeks before start of protocol treatment
* treatment started according to another protocol or pre-treatment with cytostatic drugs
* participation in another clinical trial that interferes with the protocol, except NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment, which can run parallel to LBL 2018 without influencing the outcome of this trial (e.g. trials on antiemetics, antibiotics, strategies for psychosocial support)
* evidence of pregnancy or lactation period
* sexually active adolescents not willing to use highly effective contraceptive method (pearl index \< 1) until 12 months after end of cytostatic therapy
18 Years
ALL
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
University Hospital Muenster
OTHER
Responsible Party
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Principal Investigators
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Birgit Burkhardt, Prof. Dr. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
Locations
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Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie
Graz, , Austria
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I
Innsbruck, , Austria
Kepler Universitätsklinikum, Med Campus IV / Onkologie
Linz, , Austria
LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie
Salzburg, , Austria
St. Anna Kinderspital
Vienna, , Austria
Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie
Brussels, , Belgium
University Hospital Brussels, Pediatrische oncologie
Brussels, , Belgium
Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique
Brussels, , Belgium
UZ Antwerpen Kinderhemato-oncologie
Edegem, , Belgium
University Hospital Gent Pediatrische hemato-oncologie
Ghent, , Belgium
University Hospitals Leuven, Kinderhemato-oncologie
Leuven, , Belgium
CHR Citadelle Hémato - oncologie pédiatrique
Liège, , Belgium
CHR Citadelle Hémato - oncologie pédiatrique
Montegnée, , Belgium
Hong Kong Children's Hospital
Hong Kong, , China
Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University Cernopolni
Brno, , Czechia
Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University
Prague, , Czechia
University Hospital Aalborg, Nord, Department of Pediatrics
Aalborg, , Denmark
Aarhus University Hospital, Department of Pediatrics
Aarhus, , Denmark
Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet
Copenhagen, , Denmark
H.C. Andersens Children Hospital, Odense University Hospital
Odense, , Denmark
Helsinki University Hospital, Department of Pediatric Hematology and Oncology
Helsinki, , Finland
Kuopio University Hospital, Department of Pediatric Hematology and Oncology
Kuopio, , Finland
University Hospital of Oulu, Paediatric Haematology and Oncology
Oulu, , Finland
Tampere University Hospital, Paediatric Haematology and Oncology
Tampere, , Finland
Turku University Hospital, Paediatric and Adolescent Haematology and Oncology
Turku, , Finland
Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL
Amiens, , France
Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers
Angers, , France
Hématologie Oncologie pédiatrique, CHRU Besançon
Besançon, , France
Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin
Bordeaux, , France
Département de Pédiatrie et Génétique Médicale CHRU Morvan
Brest, , France
Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH
Caen, , France
Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac
Clermont-Ferrand, , France
Service Immuno-Hématologie Oncologie Pédiatrique
Dijon, , France
Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant
Grenoble, , France
Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre
Lille, , France
Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant
Limoges, , France
Service d'immuno-hématologie pédiatrique et de transplantation de moelle osseuse, CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
Lyon, , France
Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone
Marseille, , France
UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, , France
Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES
Nantes, , France
Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2
Nice, , France
service d'oncologie pédiatrique, institut Curie
Paris, , France
Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau
Paris, , France
Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré
Paris, , France
Service Oncologie-Hématologie pédiatrique CHU de Poitiers
Poitiers, , France
Service d'Hémato-Oncologie Pédiatrique- American Hospital
Reims, , France
Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud
Rennes, , France
Service d'Hemato-Oncologie Pediatrique CHU Rouen
Rouen, , France
service d'oncologie pédiatrique, hopital Félix Guyon
Saint-Denis, , France
Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD
Saint-Priest-en-Jarez, , France
Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre
Strasbourg, , France
Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse
Toulouse, , France
Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant
Vandœuvre-lès-Nancy, , France
Dépt de Pédiatrie Gustave Roussy
Villejuif, , France
Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / Onkologie
Aachen, , Germany
Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / Onkologie
Augsburg, , Germany
HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie
Berlin, , Germany
Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / Onkologie
Berlin, , Germany
Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
Bielefeld, , Germany
Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie
Bonn, , Germany
Städtisches Klinikum Braunschweig gGmbH, Zentrum für Kinder- und Jugendmedizin
Braunschweig, , Germany
Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie
Bremen, , Germany
Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
Chemnitz, , Germany
Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie
Cologne, , Germany
Carl-Thiem-Klinikum, Kinderklinik, Station 5e
Cottbus, , Germany
Vestische Kinderklinik, Universität Witten / Herdecke
Datteln, , Germany
Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie
Dortmund, , Germany
Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin
Dresden, , Germany
Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie
Düsseldorf, , Germany
HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie
Erfurt, , Germany
Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie
Erlangen, , Germany
Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie
Essen, , Germany
Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
Frankfurt, , Germany
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie
Freiburg im Breisgau, , Germany
Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie
Giessen, , Germany
Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I
Göttingen, , Germany
Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie
Greifswald, , Germany
Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
Halle, , Germany
Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
Hamburg, , Germany
Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie
Hanover, , Germany
Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie
Heidelberg, , Germany
Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie
Herdecke, , Germany
Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9
Homburg, , Germany
Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
Jena, , Germany
Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24
Karlsruhe, , Germany
Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie
Kassel, , Germany
Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie
Kiel, , Germany
Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
Koblenz, , Germany
HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie
Krefeld, , Germany
Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie
Leipzig, , Germany
Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
Lübeck, , Germany
Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie
Magdeburg, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
Mainz, , Germany
Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie
Manheim, , Germany
Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22
Minden, , Germany
Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie
München, , Germany
Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d
München, , Germany
Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
Münster, , Germany
Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie
Nuremberg, , Germany
Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie
Oldenburg, , Germany
Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT
Regensburg, , Germany
Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie
Rostock, , Germany
Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie
Sankt Augustin, , Germany
HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1
Schwerin, , Germany
Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)
Stuttgart, , Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung
Trier, , Germany
Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie
Tübingen, , Germany
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
Ulm, , Germany
Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie
Würzburg, , Germany
2nd Dep. of Pediatrics, Semmelweis Univ
Budapest, , Hungary
Heim Pal Children Hospital
Budapest, , Hungary
Dep. of Pediatrics, Univ. of Debrecen
Debrecen, , Hungary
Children's Treating Center, Miskolc
Miskolc, , Hungary
Dep. of Pediatrics, University of Pecs
Pécs, , Hungary
Dep. of Pediatrics, Univ. of Szeged
Szeged, , Hungary
Our Lady's Children's Hospital Crumlin
Dublin, , Ireland
Children's Hospital at Soroka Medical Center
Beersheba, , Israel
Ruth Rappaport Children's Hospital, Rambam Medical Center
Haifa, , Israel
Children's Hospital at Hadassah, Ein Kerem Medical Center
Jerusalem, , Israel
Schneider Children's hospital, Rabin Medical Center
Petah Tikva, , Israel
Edmond and Lily Safra Children's Hospital, Sheba Medical Center
Ramat Gan, , Israel
Dana Children's Hospital, Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Delle Marche
Ancona, , Italy
University Hospital Consorziale Policlinico
Bari, , Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Bologna, , Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, , Italy
ARNAS G. Brotzu
Cagliari, , Italy
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Catania, , Italy
University Hospital Of Ferrara
Cona, , Italy
U. O. di Pediatria- Azienda Ospedaliera Annunziata
Cosenza, , Italy
Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara
Ferrara, , Italy
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, , Italy
Giannina Gaslini Institute For Scientific Hospitalization And Care
Genova, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliero Universitaria di Modena
Modena, , Italy
Fondazione IRCCS San Gerardo Dei Tintori
Monza, , Italy
L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
Naples, , Italy
S.C. Ematologia Oncologica- Ospedale "Pausilipon"
Napoli, , Italy
Azienda Ospedale-Università Padova
Padua, , Italy
ARNAS Civico Di Cristina Benfratelli
Palermo, , Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana
Perugia, , Italy
Azienda Sanitaria Locale Di Pescara
Pescara, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Azienda Unità Sanitaria della Romagna
Rimini, , Italy
Sezione Ematologia- Dipart. Biotecnico Cellulare ed Ematologia- Università "La Sapienza"
Roma, , Italy
Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Casa Sollievo Della Sofferenza
San Giovanni Rotondo, , Italy
Oncologia Pediatrica,- Ospedale "R. Silvestrini"
San Sisto, , Italy
Azienda Ospedaliera Universitaria Città Della Salute E Della Scienza Di Torino
Torino, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Trieste, , Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Varese, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, , Italy
Princess Maxima Centre for Pediatric Oncology
Utrecht, , Netherlands
Haukeland University Hospital in Bergen
Bergen, , Norway
University Hospital Northern Norway
Tromsø, , Norway
St Olavs Hospital in Trondheim
Trondheim, , Norway
Department of Pediatric Oncology and Hematology, Medical University of Bialystok
Bialystok, , Poland
Department of Pediatric Hematology and Oncology, Nicolaus Copernicus University
Bydgoszcz, , Poland
Department of Pediatric Hematology and Oncology, Center of Pediatrics and Oncology in Chorzów
Chorzów, , Poland
Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University of Gdansk
Gdansk, , Poland
Department of Pediatric Oncology and Hematology, Center of Pediatrics in Kielce
Kielce, , Poland
Department of Pediatric Oncology/Hematology, Institute of Pediatrics, Medical College Jagiellonian University
Krakow, , Poland
Department of Pediatrics, Oncology, Hematology and Diabetology, Institute of Pediatrics, Medical University of Lodz
Lodz, , Poland
Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin
Lublin, , Poland
Department of Pediatric Oncology and Hematology, Provincial Specialist Children's Hospital
Olsztyn, , Poland
Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences
Poznan, , Poland
Department of Paediatric Oncology and Haematology, University of Rzeszów, Department of Pediatrics
Rzeszów, , Poland
Department of Pediatrics, Children Hematology nad Oncology, Pomeranian Medical University
Szczecin, , Poland
Department of Pediatrics, Hematology and Oncology, Medical University of Warsaw
Warsaw, , Poland
Department of Pediatric Oncology, Children's Memorial Health Institute
Warsaw, , Poland
Department of Bone Marrow Transplantation, Children Oncology and Hematology, Wroclaw Medical University
Wroclaw, , Poland
Department of Pediatric Hematology and Oncology, Silesian Medical University in Katowice
Zabrze, , Poland
Centro Hospitalar e Universitário de Coimbra
Coimbra, , Portugal
Instituto Português de Oncologia - Francisco Gentil - Libosa
Lisbon, , Portugal
Instituto Português de Oncologia - Francisco Gentil - Porto
Porto, , Portugal
National Center for Pediatric Hematology, Oncology and Immunology Moscow
Moscow, , Russia
Oncological center of regional Children's Hospital
Yekaterinburg, , Russia
Department of pediatric oncology and hematology, Children´s Faculty Hospital
Banská Bystrica, , Slovakia
Department of pediatric hematology and oncology, National Institute of Children's Diseases
Bratislava, , Slovakia
Department of pediatric hematology and oncology, Children´s University Hospital
Košice, , Slovakia
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario Torrecárdenas
Almería, , Spain
Hospital Materno-Infantil de Badajoz
Badajoz, , Spain
Hospital Universitario Cruces
Barakaldo, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Donostia
Donostia / San Sebastian, , Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Hospital Virgen del Camino
Pamplona, , Spain
Complejo Hospitalario Universitario de Vigo
Pontevedra, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Barncancercentrum, Drottning Silvias Barn och Ungdomssjukhus, Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Barnonkologiska enheten, Barn och Ungdomsmedicinska kliniken, Universitetssjukhuset i Linköping
Linköping, , Sweden
Barnonkologi, Skåne Universitetssjukhus
Lund, , Sweden
Barncanceravdelningen Astrid Lindgrens Barnsjukhus, Nya Karolinska Universitetssjukhuset
Stockholm, , Sweden
Barnonkologiska avdelningen, Barn 3, Norrlands Universitetssjukhus
Umeå, , Sweden
Barnavdelningen för blod- och tumörsjukdomar 95A, Akademiska sjukhuset
Uppsala, , Sweden
Kantonsspital Aarau
Aarau, , Switzerland
Universitäts-Kinderspital beider Basel (UKBB)
Basel, , Switzerland
Ospedale San Giovanni
Bellinzona, , Switzerland
Inselspital Bern, University of Bern
Bern, , Switzerland
HUG Hôpitaux Universitaires de Genève
Geneva, , Switzerland
CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Luzerner Kantonspital - Kinderspital Luzern
Lucerne, , Switzerland
Ostschweizer Kinderspital
Sankt Gallen, , Switzerland
Universitäts-Kinderspital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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References
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Khanam T, Sandmann S, Seggewiss J, Ruether C, Zimmermann M, Norvil AB, Bartenhagen C, Randau G, Mueller S, Herbrueggen H, Hoffmann P, Herms S, Wei L, Woeste M, Wuensch C, Gowher H, Oschlies I, Klapper W, Woessmann W, Dugas M, Burkhardt B. Integrative genomic analysis of pediatric T-cell lymphoblastic lymphoma reveals candidates of clinical significance. Blood. 2021 Apr 29;137(17):2347-2359. doi: 10.1182/blood.2020005381.
Other Identifiers
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2017-001691-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UKM17_0023
Identifier Type: -
Identifier Source: org_study_id
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