International Study for Treatment of High Risk Childhood Relapsed ALL 2010 - A randomized Phase II Study Conducted by the Resistant Disease Committee of the International BFM Study Group – IntReALL HR 2010

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513070-21-00

Acronym

IntReALL HR 2010

Enrollment

222

Registered

2024-09-30

Start date

2018-02-15

Completion date

Unknown

Last updated

2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed Acute Lymphoblastic Leukemia (ALL)

Brief summary

Randomized induction trial: Improvement of CR2 rates with standard chemotherapy + Bortezomib (Arm B) quantified by cytology compared with standard chemotherapy (Arm A)

Detailed description

Improvement of three years EFS and OS, rate of patients reaching HSCT, MRD rates post induction and pre-HSCT, prognostic relevance of MRD pre HSCT, CR2 and MRD rates during consolidation, toxicity of randomized arms

Interventions

DRUGOncaspar 750 U/ml powder for solution for injection/infusion

DRUGDexamethasone phosphate Accord 4 mg/ml injeksjons-/infusjonsvæske

DRUGoppløsning

DRUGMitoxantrone 2 mg/ml concentrate for solution for infusion

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGMETHOTREXATE VIATRIS 100 mg/ml

DRUGsolution injectable

DRUGVincristine Sulfate 1 mg/ml Solution for Injection or Infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Randomized induction trial: Improvement of CR2 rates with standard chemotherapy + Bortezomib (Arm B) quantified by cytology compared with standard chemotherapy (Arm A)	—

Secondary

Measure	Time frame
Improvement of three years EFS and OS, rate of patients reaching HSCT, MRD rates post induction and pre-HSCT, prognostic relevance of MRD pre HSCT, CR2 and MRD rates during consolidation, toxicity of randomized arms	—

Countries

Austria, Belgium, Czechia, Finland, France, Germany, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026