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Trial record 15 of 48 for:    "Acute Lymphoblastic Leukemia, Childhood" | "Pegaspargase"

Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

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ClinicalTrials.gov Identifier: NCT03643276
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Martin Schrappe, University of Schleswig-Holstein

Brief Summary:

The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response ("minimal residual disease [MRD] tests") has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse.

The AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup.


Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia, Pediatric Drug: Blinatumomab Drug: Bortezomib Drug: Cyclophosphamide Drug: Cytarabine Drug: Daunorubicin Drug: DAUNOrubicin Liposomal Injection [DaunoXome] Drug: Dexamethasone Drug: Doxorubicin Drug: Etoposide Drug: Fludarabine Phosphate Drug: Ifosfamide Drug: 6-Mercaptopurine Drug: Methotrexate Drug: Pegaspargase Drug: Prednisolone Drug: Tioguanin Drug: Vincristine Drug: Vindesine Drug: Erwinase Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

pB-ALL/MR: 2 parallel groups (R-MR) or 2x2 factorial design (R-eHR, R-MR) depending on early risk group assignment.

pB-ALL/HR: 2 parallel groups (R-HR) or 2x2 factorial design (R-eHR, R-HR) depending on early risk group assignment.

T-ALL/early non-SR: 2 parallel groups (R-T).

pB-ALL/SR: Single group.

T-ALL/early SR: Single group.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : July 14, 2028
Estimated Study Completion Date : July 14, 2028


Arm Intervention/treatment
Active Comparator: pB: early (non-)HR-standard/MR-standard

Induction (5 wks): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT methotrexate (MTX)

Consolidation (6 w/4 w): "Consolidation extended" (control arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-mercaptopurine (6-MP), IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

Extra-compartment phase (8 wks): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 wks): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 years after initial diagnosis): 6-MP, MTX [without preceding blinatumomab (control arm of randomization R-MR)]

Erwinase is given in case of allergy to pegaspargase.

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Experimental: pB: early HR-exp./MR-standard

Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg/m²/dose on days 50, 53, 56 and 59)

Extra-compartment phase (8 wks): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 wks): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX [without preceding blinatumomab (control arm of randomization R-MR)]

Erwinase is given in case of allergy to pegaspargase.

Drug: Bortezomib
Experimental therapy in randomization R-eHR

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Experimental: pB: early (non)HR-standard/MR-exp.

Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Blinatumomab (4 w): 1 cycle blinatumomab given at 15 µg/m²/day for 28 days (experimental arm of randomization R-MR)

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase.

Drug: Blinatumomab
Experimental therapy in randomizations R-HR and R-MR

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Experimental: pB: early HR-exp./MR-exp.

Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg/m²/dose on days 50, 53, 56 and 59)

Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX,IT MTX

Reinduction (6 weeks): "Protocol II" with dexamethasone, vincristine, doxorubicin, PEG-L-asparaginase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Blinatumomab (4 w): 1 cycle blinatumomab given at 15 µg/m²/day for 28 days (experimental arm of randomization R-MR)

Maintenance phase (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase.

Drug: Blinatumomab
Experimental therapy in randomizations R-HR and R-MR

Drug: Bortezomib
Experimental therapy in randomization R-eHR

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Active Comparator: pB: early (non-)HR-standard/HR-standard

Induction (5 w): as in other pB arms

Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT methotrexate, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX

Intensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide

Reinduction (3x4 w): "Protocol III" given 3 times with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 yrs after init. diagnosis): 6-MP, MTX

Erwinase is given in case pegaspargase allergy. Pts with poor response to intensified consolidation receive DNX-FLA (liposomal daunorubicin, fludarabine, HD-cytarabine, IT-MTX).

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: DAUNOrubicin Liposomal Injection [DaunoXome]
Part of intensification block DNX-FLA for patients with very high relapse risk
Other Name: Liposomal Daunorubicin

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: Etoposide
Part of standard chemotherapy

Drug: Fludarabine Phosphate
Part of intensification block DNX-FLA for patients with very high relapse risk

Drug: Ifosfamide
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Vindesine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Experimental: pB: early HR-exp./HR-standard

Induction (5 w): as in other pB arms

Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg/m²/dose on days 50, 53, 56 and 59)

Intensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide

Reinduction (3x4 w): as in arm "pB: early (non-)HR-standard/HR-standard"

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive DNX-FLA (liposomal daunorubicin, fludarabine, HD-cytarabine, IT-MTX)

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: DAUNOrubicin Liposomal Injection [DaunoXome]
Part of intensification block DNX-FLA for patients with very high relapse risk
Other Name: Liposomal Daunorubicin

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: Etoposide
Part of standard chemotherapy

Drug: Fludarabine Phosphate
Part of intensification block DNX-FLA for patients with very high relapse risk

Drug: Ifosfamide
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Vindesine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Experimental: pB: early (non-)HR-standard/HR-exp.

Induction (5 w): as in other pB arms

Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX

Intensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg/m²/day for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR)

Reinduction (3x4 weeks): as in arm "pB: early (non-)HR-standard/HR-standard"

Maintenance (until 2 yrs after init. diagnosis): 6-MP, MTX

Erwinase is given in case of pegaspargase allergy. Pts with poor response to intensified consolidation receive DNX-FLA (liposomal daunorubicin, fludarabine, HD-cytarabine, IT-MTX)

Drug: Blinatumomab
Experimental therapy in randomizations R-HR and R-MR

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: DAUNOrubicin Liposomal Injection [DaunoXome]
Part of intensification block DNX-FLA for patients with very high relapse risk
Other Name: Liposomal Daunorubicin

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Experimental: pB: early HR-exp./HR-exp.

Induction (5 w): as in other pB arms

Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg/m²/dose on days 50, 53, 56 and 59)

Intensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg/m²/day for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR)

Reinduction (3x4 weeks): as in arm "pB: early (non-)HR-standard/HR-standard" Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive DNX-FLA (liposomal daunorubicin, fludarabine, HD-cytarabine, IT-MTX)

Drug: Blinatumomab
Experimental therapy in randomizations R-HR and R-MR

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: DAUNOrubicin Liposomal Injection [DaunoXome]
Part of intensification block DNX-FLA for patients with very high relapse risk
Other Name: Liposomal Daunorubicin

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

pB: early non-HR/SR

Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (4 w): "Consolidation short" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase.

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Active Comparator: T: early non-SR-standard/(non-)HR

Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or "Protocol IA-CPM" with prednisolone instead of dexamethasone and additional CPM

Consolidation (4 w): "Protocol IB regular" (control arm in randomization. R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

non-HR extra-compartment phase and reinduction: as in arm "pB: early non-HR/SR"

HR intensified consolidation and reinduction: as in arm "pB: early (non-)HR-standard/HR-standard"

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive DNX-FLA (liposomal daunorubicin, fludarabine, HD-cytarabine, IT-MTX)

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: DAUNOrubicin Liposomal Injection [DaunoXome]
Part of intensification block DNX-FLA for patients with very high relapse risk
Other Name: Liposomal Daunorubicin

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: Etoposide
Part of standard chemotherapy

Drug: Fludarabine Phosphate
Part of intensification block DNX-FLA for patients with very high relapse risk

Drug: Ifosfamide
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Vindesine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Experimental: T: early non-SR-exp/(non-)HR

Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or "Protocol IA-CPM" with prednisolone instead of dexamethasone and additional CPM

Consolidation (6 w): "Protocol IB long" (experimental arm in randomization R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

non-HR extra-compartment phase and reinduction: as in arm "pB: early non-HR/SR"

HR intensified consolidation and reinduction: as in arm "pB: early (non-)HR-standard/HR-standard"

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive DNX-FLA (liposomal daunorubicin, fludarabine, HD-cytarabine, IT-MTX)

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: DAUNOrubicin Liposomal Injection [DaunoXome]
Part of intensification block DNX-FLA for patients with very high relapse risk
Other Name: Liposomal Daunorubicin

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: Etoposide
Part of standard chemotherapy

Drug: Fludarabine Phosphate
Part of intensification block DNX-FLA for patients with very high relapse risk

Drug: Ifosfamide
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Vindesine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

T: early SR/non-HR

Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (4 w): "Protocol IB regular" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase.

Drug: Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block DNX-FLA for patients with very high relapse risk

Drug: Daunorubicin
Part of standard chemotherapy

Drug: Dexamethasone
Part of standard chemotherapy

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Drug: Methotrexate
Part of standard chemotherapy

Drug: Pegaspargase
Part of standard chemotherapy

Drug: Prednisolone
Part of standard chemotherapy
Other Name: Prednisone

Drug: Tioguanin
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy

Drug: Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction




Primary Outcome Measures :
  1. Event-free survival [ Time Frame: Assessed up to 120 months from start of study ]
    Randomization R-eHR, R-HR and R-T: Time from randomization until the first event defined as follow: cytomorphological or molecular non-response (resistance to protocol treatment, considered as event at day zero), relapse, second malignancy or death from any cause. This will be called EFS time.

  2. Disease-free survival [ Time Frame: Assessed up to 120 months from start of study ]
    Randomization R-MR: Time from randomization until the first event defined as follow: Relapse, second malignancy or death from any cause. This will be called DFS time.


Secondary Outcome Measures :
  1. Survival [ Time Frame: Assessed up to 120 months from start of study ]
    All patients/randomizations: Time until death from any cause, starting at the same time point as the EFS/DFS.

  2. Treatment-related mortality [ Time Frame: Assessed up to 120 months from start of study ]
    Frequency and incidence of treatment-related mortality in induction or continuous complete remission

  3. Adverse Events of interest/Serious Adverse Events [ Time Frame: Assessed up to 120 months from start of study ]
    Frequency and incidence of adverse events of interest and serious adverse events in specific protocol phases, randomized arms and overall during follow-up

  4. MRD response [ Time Frame: Measurements of MRD response at end of randomized treatments (intended time frame 13 weeks in R-eHR/R-T, 26 weeks in R-HR, 34 weeks in R-MR). ]
    MRD load after the randomized treatment phases (R-eHR, R-HR, R-MR and R-T) as well as after the first/second cycle of Blinatumomab or after the HR 2'/HR 3' block (R-HR)

  5. Proportion of patients with Blina Poor-Response [ Time Frame: Measurements of MRD response intended after 30 weeks from individual start of treatment, assessment of proportion at 120 months from start of study ]
    Proportion of patients with poor MRD response to the first Blinatumomab cycle ("Blinatumomab Poor-Response") (R-HR)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed acute lymphoblastic leukemia or
  • newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
  • biphenotypic with a dominant T or B lineage assignment
  • bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
  • newly diagnosed acute undifferentiated leukemia
  • age < 18 years (up to 17 years and 365 days) at the day of diagnosis
  • patient enrolled in a participating center
  • written informed consent to trial participation and transfer and processing of data A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient.

Exclusion Criteria:

  • Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
  • bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset
  • pre-treatment with cytostatic drugs
  • glucocorticoid 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 disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia…)
  • ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
  • 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 anti-leukemic therapy
  • participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor
  • live vaccine immunization within 2 weeks before start of protocol treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643276


Contacts
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Contact: Anja Möricke, MD +4943150020150 a.moericke@pediatrics.uni-kiel.de
Contact: Lile Bauer +4943150020152 lile.bauer@uksh.de

  Hide Study Locations
Locations
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Austria
Univ.Klinik für Kinder- und Jugendheilkunde Graz Recruiting
Graz, Austria
Contact: Martin Benesch         
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck Not yet recruiting
Innsbruck, Austria
Contact: Bernhard Meister         
Kepler Universitätsklinikum Not yet recruiting
Linz, Austria
Contact: Georg Ebetsberger         
LKH Salzburg Recruiting
Salzburg, Austria
Contact: Neil Jones         
St. Anna Kinderspital Recruiting
Vienna, Austria
Contact: Andishe Attarbaschi         
Czechia
University Hospital Brno Recruiting
Brno, Czechia
Contact: Jaroslav Štěrba         
University Hospital Hradec Králové Recruiting
Hradec Králové, Czechia
Contact: Jiří Hak         
University Hospital Olomouc Recruiting
Olomouc, Czechia
Contact: Dagmar Pospíšilová         
University Hospital Ostrava-Poruba Recruiting
Ostrava-Poruba, Czechia
Contact: Tomáš Kuhn         
University Hospital Plzeň Recruiting
Plzeň, Czechia
Contact: Tomáš Votava         
University Hospital Motol Recruiting
Praha, Czechia
Contact: Jan Starý         
Masaryk´s Hospital Ústí nad Labem Recruiting
Ústí nad Labem, Czechia
Contact: Daniela Procházková         
Regional Hospital České Budějovice Recruiting
České Budějovice, Czechia
Contact: Pavel Timr         
Germany
Kinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/Onkologie Recruiting
Aachen, Germany, 52074
Contact: Udo Kontny    +49 241808 ext 9902    ukontny@ukaachen.de   
I. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ Onkologie Recruiting
Augsburg, Germany, 86156
Contact: Michael Frühwald    +49 821400 ext 3631      
Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. Pädiatrie Recruiting
Berlin, Germany, 13125
Contact: Lothar Schweigerer    +49 309401 ext 2367    lschweigerer@berlin.helio-kliniken.de   
Kinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: Kinderhämatologie Recruiting
Berlin, Germany, 13353
Contact: Arend Stackelberg    +49 30450566 ext 833    arend.stackelberg@charite.de   
Städtisches Krankenhaus, Kinderklinik Recruiting
Braunschweig, Germany, 38118
Contact: Wolfgang Eberl    +49 531595 ext 1424    w.eberl@klinkum-braunschweig.de   
Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / Onkologie Recruiting
Chemnitz, Germany, 09009
Contact: Andre Hofmann    +49 3713332 ext 4287    a.hofmann@skc.de   
Carl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/Onkologie Recruiting
Cottbus, Germany, 03048
Contact: Georg Schwabe    +49 35546 ext 2332      
Vestische Kinder- u. Jugendklinik, Universitätsklinik Witten/Herdecke Recruiting
Datteln, Germany, 45711
Contact: Thomas Wiesel    +49 236397 ext 5846    th.wiesel@kinderklinik-datteln.de   
Klinikum Dortmund, Klinik f. Kinder- und Jugendmedizin Recruiting
Dortmund, Germany, 44137
Contact: Dominik Schneider    +49 2319532 ext 1050    dominik.schneider@klinikumdo.de   
Universitatsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, D-01307
Contact: R. Knöfler, MD         
Universitätsklinik Recruiting
Düsseldorf, Germany
Contact: Arndt Borkhardt, Prof.         
Helios Klinikum Erfurt GmbH, Klinik für Kinderheilkunde Recruiting
Erfurt, Germany, 99089
Contact: Axel Sauerbrey    +49 36178 ext 4501    axel.sauerbrey@helios-kliniken.de   
Universitaets - Kinderklinik Recruiting
Erlangen, Germany, 91054
Contact: M. Metzler, MD         
Universitaetsklinikum Essen Recruiting
Essen, Germany, D-45147
Contact: Rita Beier, MD         
Klinikum der J.W. Goethe Universitaet Recruiting
Frankfurt, Germany, D-60590
Contact: Thomas Klingebiel, MD    49-69-6301-5094    thomas.klingebiel@kgu.de   
Universitaetskinderklinik - Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany, D-79106
Contact: Charlotte Niemeyer, MD    49-761-270-4506    charlotte.niemeyer@uniklinik-freiburg.de   
Klinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/Onkologie Recruiting
Gießen, Germany, 35385
Contact: Christine Mauz-Körholz         
Klinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und Hämatologie Recruiting
Greifswald, Germany, 17475
Contact: Holger Lode    +49 383486 ext 6325    holger.lode@uni-greifswald.de   
Universitäts-Kinderklinik Päd. I, Hämatologie/Onkologie Recruiting
Göttingen, Germany, 37099
Contact: Ingrid Kühnle    +49 55139 ext 6201      
Medizinische Hochschule Hannover, Zentrum Kinderheilkunde u. Jugendmedizin Recruiting
Hannover, Germany, 30625
Contact: Christin Linderkamp    +49 511532 ext 6710    linderkamp.christin@mh-hannover.de   
Universitäts-Kinderklinik, Päd. Onkologie, Hämatologie, und Immunologie Recruiting
Heidelberg, Germany, 69120
Contact: Wolfgang Behnisch    +49 622156 ext 4555    wolfgang.behnisch@med.uni-heidelberg.de   
Klinikum Heilbronn GmbH, Klinik für Kinderheilkunde und Jugendmedizin/Perinatalzentrum Recruiting
Heilbronn, Germany, 74078
Contact: Hermann Full    +49 713149 ext 3702    hermann.full@slk-kliniken.de   
Gemeinschaftskrankenhaus Herdecke, Kinderabteilung Recruiting
Herdecke, Germany, 58313
Contact: Alfred Längler    +49 233062 ext 3893    a.laengler@gemeinschaftskrankenhaus.de   
Universitaetsklinikum des Saarlandes Recruiting
Homburg, Germany, 66421
Contact: Norbert Graf    49-6841-168-8397      
Klinikum, der Friedrich-Schiller-Universität, Klinik für Kinder- und Jugendmedizin Recruiting
Jena, Germany, 7740
Contact: Bernd Gruhn    +49 364193 ext 8220    bernd.gruhn@med.uni-jena.de   
Staedtisches Klinikum Karlsruhe gGmbH Recruiting
Karlsruhe, Germany, 76133
Contact: A. Leipold    49-721-9740      
Klinikum Kassel Recruiting
Kassel, Germany, D-34125
Contact: Michaela Nathrath, MD    49-561-980-3382      
Klinik für Allgemeine Paediatrie, Univ.-Klinikum Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Martin Schrappe    +49 431597 ext 1620    m.schrappe@pediatrics.uni-kiel.de   
Kliniken der Stadt Köln GmbH, Kinderkrankenhaus Riehl Recruiting
Köln, Germany, 50735
Contact: Aram Prokop    +49 2218907 ext 5158    prokopa@klinken-koeln.de   
Med. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische Station Recruiting
Köln, Germany, 50937
Contact: Thorsten Simon    +49 221478 ext 4380    thorsten.simon@uk-koeln.de   
Department für Frauen- und Kindermedizin, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie Recruiting
Leipzig, Germany, 04103
Contact: Lars Fischer    0341-97 26      
Universität zu Lübeck, Klinik für Kinder- u. Jugendmedizin, Abt. Hämatologie/ Onkologie/Immunologie Recruiting
Lübeck, Germany, 23538
Contact: Melchior Lauten    +49 451500 ext 2557    lauten@paedia.ukl.mu-luebeck.de   
Universitätsklinikum Magdeburg, Klinik für Päd. Hämatologie/Onkologie Recruiting
Magdeburg, Germany, 39120
Contact: Peter Vorwerk    +49 391671 ext 7210    peter.vorwerk@med.ovgu.de   
Klinikum Mannheim gGmbH, Kinderklinik, Abt. Hämatologie/Onkologie Recruiting
Mannheim, Germany, 68167
Contact: Matthias Dürken    +49 621383 ext 2244    matthias.duerken@kikli.ma.uni-heidelberg.de   
Universitätsklinikum Recruiting
Mannheim, Germany
Contact: Matthias Dürken, Dr.         
Johannes Wesling Klinikum Minden Recruiting
Minden, Germany, 32429
Contact: Bernhard Erdlenbruch    +49 571 ext 8010    bernhard.erdlenbruch@klinikum-minden.de   
Städt. Krankenhaus München GmbH, Krankenhaus München-Schwabingen, Kinderklinik d. TU Recruiting
München, Germany, 80804
Contact: Angela Wawer    +49 893068 ext 2261    angela.wawer@lrz.tum.de   
Universitäts-Kinderklinik, Päd. Hämatologie und Onkologie Recruiting
Münster, Germany, 48149
Contact: Claudia Rössig    +49 251834 ext 5644    rossig@ukmuenster.de   
Cnopf'sche Kinderklinik, Onkologie Recruiting
Nürnberg, Germany, 90419
Contact: Wolfram Scheurlen    +49 91133 ext 40323    wolfram.scheurlen@diakonieneudettelsau.de   
Klinikum Oldenburg gGmbH, Zentrum für Kinder- u. Jugendmedizin, (Elisabeth Kinderkrankenhaus) Recruiting
Oldenburg, Germany, 26133
Contact: Hermann Müller    +49 441403 ext 2013    mueller.hermann@klinikum-oldenburg.de   
Universitätsklinikum Recruiting
Regensburg, Germany
Contact: Selim Corbacioglu, Dr.         
Universitäts-Kinderklinik Recruiting
Rostock, Germany, 18055
Contact: Carl-Friedrich Classen    +49 381494 ext 7000    carl-friedrich.classen@med.uni-rostock.de   
Asklepios-Klinik, Sankt Augustin GmbH Recruiting
Sankt Augustin, Germany, 53757
Contact: Harald Reinhard    +49 224124 ext 9304    h.reinhard@asklepios.com   
HELIOS Kliniken Schwerin, Klinik f. Kinder-u. Jugendmedizin Recruiting
Schwerin, Germany, 19049
Contact: Christian Güttel    +49 385520 ext 2710    christian.guettel@helios-kliniken.de   
Olga-Hospital, Kinderklinik, Pädiatrisches Zentrum, Abt. Hämatologie/Onkologie Recruiting
Stuttgart, Germany, 70176
Contact: Stefan Bielack    +49 711992 ext 2461    st.bielack@olgahospital.de   
Krankenanstalt Trier, Mutterhaus der Borromaeerinnen, Pädiatrische Abteilung Recruiting
Trier, Germany, 54290
Contact: Stefan Weis    +49 651947 ext 2654    weis@mutterhaus.de   
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Germany, D-72076
Contact: Martin Ebinger, MD         
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm Recruiting
Ulm, Germany, D-89075
Contact: Klaus M. Debatin, MD    49-731-5000    klaus-michael.debatin@medizin.uni-ulm.de   
Stadtkrankenhaus, Kinderklinik Recruiting
Wolfsburg, Germany, 38440
Contact: Sally Mukodzi    +49 5361 ext 8000    sally.mukidzi@klinikum-wolfsburg.de   
Universitaets - Kinderklinik Wuerzburg Recruiting
Wuerzburg, Germany, D-97080
Contact: P. G. Schlegel, MD    49-931-2012-7856    schlegel@mail.uni-wuerzburg.de   
Israel
Soroka University Medical Center Not yet recruiting
Beer Sheva, Israel
Contact: Joseph Kapelushnik         
Rambam Health Care Campus Not yet recruiting
Haifa, Israel
Contact: Nira Arad-Cohen         
Hadassah Medical center Not yet recruiting
Jerusalem, Israel
Contact: Gal Goldstein         
Schneider Children Medical Center of Israel Not yet recruiting
Petach-Tikva, Israel
Contact: Gil Gilad         
Sheba Medical Center Tel-Hashomer Not yet recruiting
Ramat Gan, Israel
Contact: Bella Bielorai         
Dana children hospital Not yet recruiting
Tel-Aviv, Israel
Contact: Ronit Elhasid         
Italy
Azienda ospedali riuniti Recruiting
Ancona, Italy
Contact: Paolo Pierani         
AOUC Policlinico Bari Recruiting
Bari, Italy
Contact: Nicola Santoro         
A.O. Papa Giovanni XXIII Recruiting
Bergamo, Italy
Contact: Massimo Provenzi         
Università di Bologna Recruiting
Bologna, Italy
Contact: Andrea Pession         
ASST Spedali Civili di Brescia Recruiting
Brescia, Italy
Contact: Fulvio Porta         
Ospedale Businco Recruiting
Cagliari, Italy
Contact: Rosa Maria Mura         
Azienda ospedaliero universitaria Recruiting
Catania, Italy
Contact: Luca Lo Nigro         
AO Pugliese Ciaccio Recruiting
Catanzaro, Italy
Contact: Caterina Consarino         
S.O. Annunziata - A. O. Cosenza Recruiting
Cosenza, Italy
Contact: Domenico Sperlì         
Ospedale Meyer Recruiting
Firenze, Italy
Contact: Tommaso Casini         
Istituto Giannina Gaslini Recruiting
Genova, Italy
Contact: Concetta Micalizzi         
Policlinico di Modena Azienda Ospedaliero-Universitaria Recruiting
Modena, Italy
Contact: Monica Cellini         
Clinica pediatrica Fondazione MBBM Recruiting
Monza, Italy
Contact: Andrea Biondi         
A.O.U. Vanvitelli Recruiting
Napoli, Italy
Contact: Francesca Rossi         
AORN Santobono Pausilipon Recruiting
Napoli, Italy
Contact: Rosanna Parasole         
Azienda ospedaliera di Padova Recruiting
Padova, Italy
Contact: Maria Caterina Putti         
Ospedale Civico ARNAS Civico e Di Cristina Recruiting
Palermo, Italy
Contact: Ottavio Ziino         
Azienda ospedaliero-universitaria di Parma Recruiting
Parma, Italy
Contact: Angelica Barone         
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy
Contact: Marco Zecca         
Ospedale S. Maria della misericordia Recruiting
Perugia, Italy
Contact: Maurizio Caniglia         
Ospedale Civile di Pescara Recruiting
Pescara, Italy
Contact: Daniela Onofrillo         
Ospedale Santa Chiara Pisa Recruiting
Pisa, Italy
Contact: Emanuela De Marco         
Grande ospedale metropolitano B-M-M Recruiting
Reggio Calabria, Italy
Contact: Francesca Ronco         
Ospedale infermi Recruiting
Rimini, Italy
Contact: Roberta Pericoli         
Fondazione Policlinico Gemelli Recruiting
Roma, Italy
Contact: Antonio Ruggiero         
Ospedale Bambino Gesù Recruiting
Roma, Italy
Contact: Franco Locatelli         
Policlinico Umberto I Università Sapienza di Roma Recruiting
Roma, Italy
Contact: Robin Foà         
Ospedale "Casa sollievo della sofferenza" Recruiting
San Giovanni Rotondo, Italy
Contact: Saverio Ladogana         
A.O.U. Città della salute e della scienza di Torino Recruiting
Torino, Italy
Contact: Franca Fagioli         
IRCCS Burlo Garofolo Recruiting
Trieste, Italy
Contact: Valentina Kiren         
AOU Verona Recruiting
Verona, Italy
Contact: Simone Cesaro         
Slovakia
Klinika pediatrickej hematológie a onkológie SZU a DFNsP Recruiting
Banská Bystrica, Slovakia
Contact: Eva Bubanská         
Comenius University Children's Hospital Recruiting
Bratislava, Slovakia
Contact: Alexandra Kolenova         
Detská fakultná nemocnica Košice Recruiting
Košice, Slovakia
Contact: Natália Galóová         
Switzerland
Kantonsspital Aarau Not yet recruiting
Aarau, Switzerland
Contact: Katrin Scheinemann         
Universitäts-Kinderspital beider Basel Not yet recruiting
Basel, Switzerland
Contact: Nicolas von der Weid         
Ospedale San Giovanni Bellinzona Not yet recruiting
Bellinzona, Switzerland
Contact: Pierluigi Brazzola         
Inselspital Bern Not yet recruiting
Bern, Switzerland
Contact: Jochen Rössler         
HUG Hôpitaux Universitaires de Gèneve Not yet recruiting
Genève, Switzerland
Contact: Frederic Baleydier         
CHUV Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Switzerland
Contact: Francesco Ceppi         
Luzerner Kantonsspital-Kinderspital Luzern Not yet recruiting
Luzern, Switzerland
Contact: Freimut Schilling         
Ostschweizer Kinderspital Not yet recruiting
St. Gallen, Switzerland
Contact: Jeanette Greiner         
Universitäts-Kinderspital Zürich Not yet recruiting
Zürich, Switzerland
Contact: Felix Niggli         
Sponsors and Collaborators
Martin Schrappe
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
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Principal Investigator: Martin Schrappe, MD Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel

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Responsible Party: Martin Schrappe, Professor MD, FRCP (Glasg), Chair of Pediatrics I, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03643276     History of Changes
Other Study ID Numbers: AIEOP-BFM ALL 2017
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Schrappe, University of Schleswig-Holstein:
Acute Lymphoblastic Leukemia
Childhood
Pediatric
Immunotherapy
Blinatumomab
Proteasome Inhibitor
Bispecific antibody
Bortezomib
Chemotherapy
Randomized trial
Additional relevant MeSH terms:
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Pegaspargase
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Dexamethasone acetate
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Methotrexate
Fludarabine
Fludarabine phosphate
Etoposide
Etoposide phosphate
Bortezomib
Vincristine
Ifosfamide
Isophosphamide mustard