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Treatment Protocol for Childr...

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

Last Updated: 2025-04-06

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2028-07-14

Brief Summary

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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.

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Detailed Description

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Patients are stratified into 4 early risk groups for therapy during the consolidation phase (T/early SR, T/early non-SR, pB/early non-HR, pB/early HR) and 5 risk groups for post-consolidation therapy (T/non-HR, T/HR, pB/SR, pB/MR, pB/HR). Risk stratification is based on immunophenotypic lineage, genetics of leukemic cells and treatment response on the basis of cytomorphology and methods for detection minimal residual disease.

The trial includes four randomized study questions testing experimental treatments on top of the risk-stratified standard chemotherapy backbone:

Primary study questions:

Randomization R-eHR: Early High-risk (early HR) pB-ALL defined by genetics and/or inadequate treatment response over the course of induction: Can the probability of event-free survival (pEFS) from time of randomization be improved by additional therapy with the proteasome inhibitor bortezomib during an extended consolidation treatment phase compared with standard extended consolidation?

Randomization R-HR: High-risk (HR) pB-ALL defined by genetics and/or inadequate treatment response by the end of consolidation: Can the pEFS from time of randomization be improved by a treatment concept including two cycles of post-consolidation immunotherapy with blinatumomab (15 µg/m²/d for 28 days per cycle) plus 4 doses intrathecal Methotrexate replacing two conventional highly intensive chemotherapy courses?

Randomization R-MR: Intermediate risk (MR) pB-ALL defined by genetics and intermediate MRD response: Can the probability of disease-free survival (pDFS) from time of randomization be improved by additional therapy with one cycle of post-reintensification immunotherapy with blinatumomab (15 µg/m²/d for 28 days)?

Randomization R-T: Early non-standard risk (early non-SR) T-ALL patients defined by treatment response over the course of induction: Can the pEFS from time of randomization be improved by the extension of the standard of care consolidation phase by 14 days with an increase of the consolidation cumulative doses of Cyclophosphamide, Cytarabine and 6-Mercaptopurine by 50%?

Secondary study questions:

All randomizations: Can the overall survival be improved by the treatment in the experimental arm?

All randomizations: What is the incidence of treatment-related toxicities and mortality in the experimental arm compared to the standard arm?

Randomization R-eHR: Can the MRD load after consolidation treatment be reduced by the additional treatment with bortezomib?

Randomization R-HR: Can treatment-related life-threatening complications and mortality during the intensified consolidation phase of high-risk treatment be reduced when replacing two intensive chemotherapy courses by two cycles of immunotherapy with blinatumomab?

Randomization R-HR: What is the proportion of patients with insufficient MRD response to blinatumomab as defined in the protocol as compared to the MRD response after the HR-2' block in the control arm?

Randomization R-HR: Can the MRD load after the first treatment cycle (HR 2'/blinatumomab) and the second cycle (HR-3'/blinatumomab) be reduced in the experimental arm when compared with conventional intensive chemotherapy? Randomization R-MR: What is the proportion of patients with positive MRD after reintensification Protocol II who become MRD-negative over the blinatumomab cycle compared to 4 weeks of standard maintenance therapy?

Randomization R-T: Can the MRD load after consolidation treatment be reduced by extension of the consolidation phase?

Standard-risk patients: Is the clinical outcome comparable to that obtained for standard-risk patients in study AIEOP-BFM ALL 2009?

A small subgroup of patients at very high relapse risk is eligible for allogeneic hematopoietic stem cell transplantation after the intensified consolidation therapy phase.

Patients with T-ALL and hyperleukocytosis (\>=100,000/µL) and patients with CNS involvement at diagnosis (CNS3 status) are eligible for cranial irradiation with 12 Gy if age at time of irradiation is at least 4 years.

Conditions

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Acute Lymphoblastic Leukemia, Pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Bortezomib

Intervention Type DRUG

Experimental therapy in randomization R-eHR

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Blinatumomab

Intervention Type DRUG

Experimental therapy in randomizations R-HR and R-MR

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Blinatumomab

Intervention Type DRUG

Experimental therapy in randomizations R-HR and R-MR

Bortezomib

Intervention Type DRUG

Experimental therapy in randomization R-eHR

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

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 Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX).

Group Type ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Myocet

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

Etoposide

Intervention Type DRUG

Part of standard chemotherapy

Fludarabine Phosphate

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Ifosfamide

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Vindesine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

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 Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Myocet

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

Etoposide

Intervention Type DRUG

Part of standard chemotherapy

Fludarabine Phosphate

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Ifosfamide

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Vindesine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

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 Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Group Type EXPERIMENTAL

Blinatumomab

Intervention Type DRUG

Experimental therapy in randomizations R-HR and R-MR

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Myocet

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

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 Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Group Type EXPERIMENTAL

Blinatumomab

Intervention Type DRUG

Experimental therapy in randomizations R-HR and R-MR

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Myocet

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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.

Group Type OTHER

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

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 Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Group Type ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Myocet

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

Etoposide

Intervention Type DRUG

Part of standard chemotherapy

Fludarabine Phosphate

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Ifosfamide

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Vindesine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

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 Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Myocet

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

Etoposide

Intervention Type DRUG

Part of standard chemotherapy

Fludarabine Phosphate

Intervention Type DRUG

Part of intensification block Myocet-FLA for patients with very high relapse risk

Ifosfamide

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Vindesine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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.

Group Type OTHER

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

Part of standard chemotherapy

Dexamethasone

Intervention Type DRUG

Part of standard chemotherapy

Doxorubicin

Intervention Type DRUG

Part of standard chemotherapy

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Part of standard chemotherapy

Pegaspargase

Intervention Type DRUG

Part of standard chemotherapy

Prednisolone

Intervention Type DRUG

Part of standard chemotherapy

Tioguanin

Intervention Type DRUG

Part of standard chemotherapy

Vincristine

Intervention Type DRUG

Part of standard chemotherapy

Erwinase

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blinatumomab

Experimental therapy in randomizations R-HR and R-MR

Intervention Type DRUG

Bortezomib

Experimental therapy in randomization R-eHR

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Cytarabine

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

Intervention Type DRUG

Daunorubicin

Part of standard chemotherapy

Intervention Type DRUG

Myocet

Part of intensification block Myocet-FLA for patients with very high relapse risk

Intervention Type DRUG

Dexamethasone

Part of standard chemotherapy

Intervention Type DRUG

Doxorubicin

Part of standard chemotherapy

Intervention Type DRUG

Etoposide

Part of standard chemotherapy

Intervention Type DRUG

Fludarabine Phosphate

Part of intensification block Myocet-FLA for patients with very high relapse risk

Intervention Type DRUG

Ifosfamide

Part of standard chemotherapy

Intervention Type DRUG

6-Mercaptopurine

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

Intervention Type DRUG

Methotrexate

Part of standard chemotherapy

Intervention Type DRUG

Pegaspargase

Part of standard chemotherapy

Intervention Type DRUG

Prednisolone

Part of standard chemotherapy

Intervention Type DRUG

Tioguanin

Part of standard chemotherapy

Intervention Type DRUG

Vincristine

Part of standard chemotherapy

Intervention Type DRUG

Vindesine

Part of standard chemotherapy

Intervention Type DRUG

Erwinase

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

Intervention Type DRUG

Other Intervention Names

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Prednisone

Eligibility Criteria

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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

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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Martin Schrappe

Professor MD, FRCP (Glasg), Chair of Pediatrics I

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Martin Schrappe, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sydney Children's Hospital

Sydney, , Australia

Site Status RECRUITING

The Children's Hospital at Westmead

Westmead, , Australia

Site Status RECRUITING

Univ.Klinik für Kinder- und Jugendheilkunde Graz

Graz, , Austria

Site Status RECRUITING

Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Kepler Universitätsklinikum

Linz, , Austria

Site Status RECRUITING

LKH Salzburg

Salzburg, , Austria

Site Status RECRUITING

St. Anna Kinderspital

Vienna, , Austria

Site Status RECRUITING

University Hospital Brno

Brno, , Czechia

Site Status RECRUITING

Regional Hospital České Budějovice

České Budějovice, , Czechia

Site Status RECRUITING

University Hospital Hradec Králové

Hradec Králové, , Czechia

Site Status RECRUITING

University Hospital Olomouc

Olomouc, , Czechia

Site Status RECRUITING

University Hospital Ostrava-Poruba

Ostrava-Poruba, , Czechia

Site Status RECRUITING

University Hospital Plzeň

Pilsen, , Czechia

Site Status RECRUITING

University Hospital Motol

Prague, , Czechia

Site Status RECRUITING

Masaryk´s Hospital Ústí nad Labem

Ústí nad Labem, , Czechia

Site Status RECRUITING

Kinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/Onkologie

Aachen, , Germany

Site Status RECRUITING

I. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ Onkologie

Augsburg, , Germany

Site Status RECRUITING

Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. Pädiatrie

Berlin, , Germany

Site Status RECRUITING

Kinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: Kinderhämatologie

Berlin, , Germany

Site Status RECRUITING

Städtisches Krankenhaus, Kinderklinik

Braunschweig, , Germany

Site Status RECRUITING

Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / Onkologie

Chemnitz, , Germany

Site Status RECRUITING

Kliniken der Stadt Köln GmbH, Kinderkrankenhaus Riehl

Cologne, , Germany

Site Status RECRUITING

Med. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische Station

Cologne, , Germany

Site Status RECRUITING

Carl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/Onkologie

Cottbus, , Germany

Site Status RECRUITING

Vestische Kinder- u. Jugendklinik, Universitätsklinik Witten/Herdecke

Datteln, , Germany

Site Status RECRUITING

Klinikum Dortmund, Klinik f. Kinder- und Jugendmedizin

Dortmund, , Germany

Site Status RECRUITING

Universitatsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status RECRUITING

Universitätsklinik

Düsseldorf, , Germany

Site Status RECRUITING

Helios Klinikum Erfurt GmbH, Klinik für Kinderheilkunde

Erfurt, , Germany

Site Status RECRUITING

Universitaets - Kinderklinik

Erlangen, , Germany

Site Status RECRUITING

Universitaetsklinikum Essen

Essen, , Germany

Site Status RECRUITING

Klinikum der J.W. Goethe Universitaet

Frankfurt, , Germany

Site Status RECRUITING

Universitaetskinderklinik - Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Klinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/Onkologie

Giessen, , Germany

Site Status RECRUITING

Universitäts-Kinderklinik Päd. I, Hämatologie/Onkologie

Göttingen, , Germany

Site Status RECRUITING

Klinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und Hämatologie

Greifswald, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover, Zentrum Kinderheilkunde u. Jugendmedizin

Hanover, , Germany

Site Status RECRUITING

Universitäts-Kinderklinik, Päd. Onkologie, Hämatologie, und Immunologie

Heidelberg, , Germany

Site Status RECRUITING

Klinikum Heilbronn GmbH, Klinik für Kinderheilkunde und Jugendmedizin/Perinatalzentrum

Heilbronn, , Germany

Site Status RECRUITING

Gemeinschaftskrankenhaus Herdecke, Kinderabteilung

Herdecke, , Germany

Site Status RECRUITING

Universitaetsklinikum des Saarlandes

Homburg, , Germany

Site Status RECRUITING

Klinikum, der Friedrich-Schiller-Universität, Klinik für Kinder- und Jugendmedizin

Jena, , Germany

Site Status RECRUITING

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, , Germany

Site Status RECRUITING

Klinikum Kassel

Kassel, , Germany

Site Status RECRUITING

Klinik für Allgemeine Paediatrie, Univ.-Klinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status RECRUITING

Department für Frauen- und Kindermedizin, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie

Leipzig, , Germany

Site Status RECRUITING

Universität zu Lübeck, Klinik für Kinder- u. Jugendmedizin, Abt. Hämatologie/ Onkologie/Immunologie

Lübeck, , Germany

Site Status RECRUITING

Universitätsklinikum Magdeburg, Klinik für Päd. Hämatologie/Onkologie

Magdeburg, , Germany

Site Status RECRUITING

Klinikum Mannheim gGmbH, Kinderklinik, Abt. Hämatologie/Onkologie

Mannheim, , Germany

Site Status RECRUITING

Universitätsklinikum

Mannheim, , Germany

Site Status RECRUITING

Johannes Wesling Klinikum Minden

Minden, , Germany

Site Status RECRUITING

Städt. Krankenhaus München GmbH, Krankenhaus München-Schwabingen, Kinderklinik d. TU

München, , Germany

Site Status RECRUITING

Ludwig-Maximilian-Universität, Dr. von Haunersches Kinderspital

München, , Germany

Site Status RECRUITING

Universitäts-Kinderklinik, Päd. Hämatologie und Onkologie

Münster, , Germany

Site Status RECRUITING

Cnopf'sche Kinderklinik, Onkologie

Nuremberg, , Germany

Site Status RECRUITING

Klinikum Oldenburg gGmbH, Zentrum für Kinder- u. Jugendmedizin, (Elisabeth Kinderkrankenhaus)

Oldenburg, , Germany

Site Status RECRUITING

Universitätsklinikum

Regensburg, , Germany

Site Status RECRUITING

Universitäts-Kinderklinik

Rostock, , Germany

Site Status RECRUITING

Asklepios-Klinik, Sankt Augustin GmbH

Sankt Augustin, , Germany

Site Status RECRUITING

HELIOS Kliniken Schwerin, Klinik f. Kinder-u. Jugendmedizin

Schwerin, , Germany

Site Status RECRUITING

Olga-Hospital, Kinderklinik, Pädiatrisches Zentrum, Abt. Hämatologie/Onkologie

Stuttgart, , Germany

Site Status RECRUITING

Krankenanstalt Trier, Mutterhaus der Borromaeerinnen, Pädiatrische Abteilung

Trier, , Germany

Site Status RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Site Status RECRUITING

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, , Germany

Site Status RECRUITING

Stadtkrankenhaus, Kinderklinik

Wolfsburg, , Germany

Site Status RECRUITING

Universitaets - Kinderklinik Wuerzburg

Würzburg, , Germany

Site Status RECRUITING

Soroka University Medical Center

Beersheba, , Israel

Site Status RECRUITING

Rambam Health Care Campus

Haifa, , Israel

Site Status RECRUITING

Hadassah Medical center

Jerusalem, , Israel

Site Status RECRUITING

Schneider Children Medical Center of Israel

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center Tel-Hashomer

Ramat Gan, , Israel

Site Status RECRUITING

Dana children hospital

Tel Aviv, , Israel

Site Status RECRUITING

Azienda ospedali riuniti

Ancona, , Italy

Site Status RECRUITING

AOUC Policlinico Bari

Bari, , Italy

Site Status RECRUITING

A.O. Papa Giovanni XXIII

Bergamo, , Italy

Site Status RECRUITING

Università di Bologna

Bologna, , Italy

Site Status RECRUITING

ASST Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

Ospedale Businco

Cagliari, , Italy

Site Status RECRUITING

Azienda ospedaliero universitaria

Catania, , Italy

Site Status RECRUITING

AO Pugliese Ciaccio

Catanzaro, , Italy

Site Status RECRUITING

S.O. Annunziata - A. O. Cosenza

Cosenza, , Italy

Site Status RECRUITING

Ospedale Meyer

Florence, , Italy

Site Status RECRUITING

Istituto Giannina Gaslini

Genova, , Italy

Site Status RECRUITING

Policlinico di Modena Azienda Ospedaliero-Universitaria

Modena, , Italy

Site Status RECRUITING

Clinica pediatrica Fondazione MBBM

Monza, , Italy

Site Status RECRUITING

A.O.U. Vanvitelli

Napoli, , Italy

Site Status RECRUITING

AORN Santobono Pausilipon

Napoli, , Italy

Site Status RECRUITING

Azienda ospedaliera di Padova

Padua, , Italy

Site Status RECRUITING

Ospedale Civico ARNAS Civico e Di Cristina

Palermo, , Italy

Site Status RECRUITING

Azienda ospedaliero-universitaria di Parma

Parma, , Italy

Site Status RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status RECRUITING

Ospedale S. Maria della misericordia

Perugia, , Italy

Site Status RECRUITING

Ospedale Civile di Pescara

Pescara, , Italy

Site Status RECRUITING

Ospedale Santa Chiara Pisa

Pisa, , Italy

Site Status RECRUITING

Grande ospedale metropolitano B-M-M

Reggio Calabria, , Italy

Site Status RECRUITING

Ospedale infermi

Rimini, , Italy

Site Status RECRUITING

Fondazione Policlinico Gemelli

Roma, , Italy

Site Status RECRUITING

Ospedale Bambino Gesù

Roma, , Italy

Site Status RECRUITING

Policlinico Umberto I Università Sapienza di Roma

Roma, , Italy

Site Status RECRUITING

Ospedale "Casa sollievo della sofferenza"

San Giovanni Rotondo, , Italy

Site Status RECRUITING

A.O.U. Città della salute e della scienza di Torino

Torino, , Italy

Site Status RECRUITING

IRCCS Burlo Garofolo

Trieste, , Italy

Site Status RECRUITING

AOU Verona

Verona, , Italy

Site Status RECRUITING

Klinika pediatrickej hematológie a onkológie SZU a DFNsP

Banská Bystrica, , Slovakia

Site Status RECRUITING

Comenius University Children's Hospital

Bratislava, , Slovakia

Site Status RECRUITING

Detská fakultná nemocnica Košice

Košice, , Slovakia

Site Status RECRUITING

Kantonsspital Aarau

Aarau, , Switzerland

Site Status RECRUITING

Universitäts-Kinderspital beider Basel

Basel, , Switzerland

Site Status RECRUITING

Ospedale San Giovanni Bellinzona

Bellinzona, , Switzerland

Site Status RECRUITING

Inselspital Bern

Bern, , Switzerland

Site Status RECRUITING

HUG Hôpitaux Universitaires de Gèneve

Geneva, , Switzerland

Site Status RECRUITING

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status RECRUITING

Luzerner Kantonsspital-Kinderspital Luzern

Lucerne, , Switzerland

Site Status RECRUITING

Ostschweizer Kinderspital

Sankt Gallen, , Switzerland

Site Status RECRUITING

Universitäts-Kinderspital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Australia Austria Czechia Germany Israel Italy Slovakia Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anja Möricke, MD

Role: CONTACT

[email protected]

+4943150020150

Lile Bauer

Role: CONTACT

[email protected]

+4943150020152

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Draga Barbaric

Role: primary

Luciano Dalla-Pozza

Role: primary

Martin Benesch

Role: primary

Bernhard Meister

Role: primary

Georg Ebetsberger

Role: primary

Neil Jones

Role: primary

Andishe Attarbaschi

Role: primary

Jaroslav Štěrba

Role: primary

Pavel Timr

Role: primary

Jiří Hak

Role: primary

Dagmar Pospíšilová

Role: primary

Tomáš Kuhn

Role: primary

Tomáš Votava

Role: primary

Jan Starý

Role: primary

Daniela Procházková

Role: primary

Udo Kontny

Role: primary

[email protected]

+49 241808 ext. 9902

Michael Frühwald

Role: primary

+49 821400 ext. 3631

Lothar Schweigerer

Role: primary

[email protected]

+49 309401 ext. 2367

Arend Stackelberg

Role: primary

[email protected]

+49 30450566 ext. 833

Wolfgang Eberl

Role: primary

[email protected]

+49 531595 ext. 1424

Andre Hofmann

Role: primary

[email protected]

+49 3713332 ext. 4287

Aram Prokop

Role: primary

[email protected]

+49 2218907 ext. 5158

Thorsten Simon

Role: primary

[email protected]

+49 221478 ext. 4380

Georg Schwabe

Role: primary

+49 35546 ext. 2332

Thomas Wiesel

Role: primary

[email protected]

+49 236397 ext. 5846

Dominik Schneider

Role: primary

[email protected]

+49 2319532 ext. 1050

R. Knöfler, MD

Role: primary

Arndt Borkhardt, Prof.

Role: primary

Axel Sauerbrey

Role: primary

[email protected]

+49 36178 ext. 4501

M. Metzler, MD

Role: primary

Rita Beier, MD

Role: primary

Thomas Klingebiel, MD

Role: primary

[email protected]

49-69-6301-5094

Charlotte Niemeyer, MD

Role: primary

[email protected]

49-761-270-4506

Christine Mauz-Körholz

Role: primary

Ingrid Kühnle

Role: primary

+49 55139 ext. 6201

Holger Lode

Role: primary

[email protected]

+49 383486 ext. 6325

Christin Linderkamp

Role: primary

[email protected]

+49 511532 ext. 6710

Wolfgang Behnisch

Role: primary

[email protected]

+49 622156 ext. 4555

Hermann Full

Role: primary

[email protected]

+49 713149 ext. 3702

Alfred Längler

Role: primary

[email protected]

+49 233062 ext. 3893

Norbert Graf

Role: primary

49-6841-168-8397

Bernd Gruhn

Role: primary

[email protected]

+49 364193 ext. 8220

A. Leipold

Role: primary

49-721-9740

Michaela Nathrath, MD

Role: primary

49-561-980-3382

Martin Schrappe

Role: primary

[email protected]

+49 431597 ext. 1620

Lars Fischer

Role: primary

0341-97 26

Melchior Lauten

Role: primary

[email protected]

+49 451500 ext. 2557

Peter Vorwerk

Role: primary

[email protected]

+49 391671 ext. 7210

Matthias Dürken

Role: primary

[email protected]

+49 621383 ext. 2244

Matthias Dürken, Dr.

Role: primary

Bernhard Erdlenbruch

Role: primary

[email protected]

+49 571 ext. 8010

Angela Wawer

Role: primary

[email protected]

+49 893068 ext. 2261

Tobias Feuchtinger

Role: primary

Claudia Rössig

Role: primary

[email protected]

+49 251834 ext. 5644

Wolfram Scheurlen

Role: primary

[email protected]

+49 91133 ext. 40323

Hermann Müller

Role: primary

[email protected]

+49 441403 ext. 2013

Selim Corbacioglu, Dr.

Role: primary

Carl-Friedrich Classen

Role: primary

[email protected]

+49 381494 ext. 7000

Harald Reinhard

Role: primary

[email protected]

+49 224124 ext. 9304

Christian Güttel

Role: primary

[email protected]

+49 385520 ext. 2710

Stefan Bielack

Role: primary

[email protected]

+49 711992 ext. 2461

Stefan Weis

Role: primary

[email protected]

+49 651947 ext. 2654

Martin Ebinger, MD

Role: primary

Klaus M. Debatin, MD

Role: primary

[email protected]

49-731-5000

Sally Mukodzi

Role: primary

[email protected]

+49 5361 ext. 8000

P. G. Schlegel, MD

Role: primary

[email protected]

49-931-2012-7856

Joseph Kapelushnik

Role: primary

Nira Arad-Cohen

Role: primary

Gal Goldstein

Role: primary

Gil Gilad

Role: primary

Bella Bielorai

Role: primary

Ronit Elhasid

Role: primary

Paolo Pierani

Role: primary

Nicola Santoro

Role: primary

Massimo Provenzi

Role: primary

Andrea Pession

Role: primary

Fulvio Porta

Role: primary

Rosa Maria Mura

Role: primary

Luca Lo Nigro

Role: primary

Caterina Consarino

Role: primary

Domenico Sperlì

Role: primary

Tommaso Casini

Role: primary

Concetta Micalizzi

Role: primary

Monica Cellini

Role: primary

Andrea Biondi

Role: primary

Francesca Rossi

Role: primary

Rosanna Parasole

Role: primary

Maria Caterina Putti

Role: primary

Ottavio Ziino

Role: primary

Angelica Barone

Role: primary

Marco Zecca

Role: primary

Maurizio Caniglia

Role: primary

Daniela Onofrillo

Role: primary

Emanuela De Marco

Role: primary

Francesca Ronco

Role: primary

Roberta Pericoli

Role: primary

Antonio Ruggiero

Role: primary

Franco Locatelli

Role: primary

Robin Foà

Role: primary

Saverio Ladogana

Role: primary

Franca Fagioli

Role: primary

Valentina Kiren

Role: primary

Simone Cesaro

Role: primary

Eva Bubanská

Role: primary

Alexandra Kolenova

Role: primary

Natália Galóová

Role: primary

Katrin Scheinemann

Role: primary

Nicolas von der Weid

Role: primary

Pierluigi Brazzola

Role: primary

Jochen Rössler

Role: primary

Frederic Baleydier

Role: primary

Francesco Ceppi

Role: primary

Freimut Schilling

Role: primary

Jeanette Greiner

Role: primary

Felix Niggli

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Tufekci O, Evim MS, Gunes AM, Celkan T, Karapinar DY, Kaya Z, Baysal B, Baytan B, Kocak U, Yilmaz S, Cinar S, Oren H. Assessment of Minimal Residual Disease in Childhood Acute Lymphoblastic Leukemia: A Multicenter Study From Turkey. J Pediatr Hematol Oncol. 2022 Mar 1;44(2):e396-e402. doi: 10.1097/MPH.0000000000002419.

Reference Type DERIVED

PMID: 35129146 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AIEOP-BFM ALL 2017

Identifier Type: -

Identifier Source: org_study_id

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