International Study for Treatment of Standard Risk Childhood Relapsed ALL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27511

Enrollment

Registered

2014-08-05

Start date

2017-04-04

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

IntReALL, Relapsed ALL 2010

Interventions

Epratuzumab

Eligibility

Age

No minimum to 17 Years

Inclusion criteria

Inclusion criteria: Eerste recidief voorloper-B ALL (BCP-ALL) of T-ALL Kinderen jonger dan 18 jaar Voldoen aan 'SR-criteria': laat geisoleerd of vroeg/laat gecombineerd BCP-ALL beenmergrecidief, vroeg/laat geisoleerd extramedullair recidief. Behandeling in participerend centrum Ondertekend informed consent Geen deelname aan interfererende studie anders dan upfront-ALL behandeling 30-dagen voorafgaand aan inclusie, Inclusiecriteria voor epratuzumab randomisatie: (randomisatie gesloten per 01-02-2019) Voorloper B-cel immunofenotype van de ALL M1 of M2 beenmerg na de inductie

Exclusion criteria

Exclusion criteria: BCR-ABL / t(9;22) positieve ALL Zwangerschap of positieve zwangerschapstest (urine positief voor beta-HCG > 10 U/l) Sexueel active adolescenten die niet bereid zijn tot effectief anti-conceptie beleid tot 2 jaar na stop behandeling Borstvoeding Recidief na allogene stam-cell transplantatie Weigering te vol participeren in relevante onderdelen van het protocol door patient of ouders/begeleiders. Geen informed consent Ernstige comorbiditeit die de voorgestelde behandeling belet (ter beoordeling van behandelende kinderoncoloog) Personen die niet bereid zijn aan de studie-procedures te voldoen Personen in wettelijke gevangenschap

Design outcomes

Primary

Measure	Time frame
Primary parameters: - Overall: Improvement of event-free survival (EFS) probabilities in childhood relapsed ALL - Randomization 1: EFS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients - Randomization 2: Influence of epratuzumab on EFS in consolidation of SR patients	—

Secondary

Measure	Time frame
Secondary parameters: - OS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients - Influence of epratuzumab on OS in consolidation of SR patients - Rate of second complete remission (CR2) of Arm A versus Arm B - Rate of SCT performed in Arm A versus Arm B - Toxicity of randomized SR arms A versus B - Toxicity of consolidation with versus without epratuzumab - Improvement of MRD reduction during consolidation with versus without epratuzumab - Rate of MRD negativity prior to SCT with Arm A vs. Arm B - Rate of MRD negativity prior to SCT after consolidation with versus without epratuzumab - Pharmacokinetic of epratuzumab in context with arm A and arm B	—

Measure

Time frame

Secondary parameters: - OS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients - Influence of epratuzumab on OS in consolidation of SR patients - Rate of second complete remission (CR2) of Arm A versus Arm B - Rate of SCT performed in Arm A versus Arm B - Toxicity of randomized SR arms A versus B - Toxicity of consolidation with versus without epratuzumab - Improvement of MRD reduction during consolidation with versus without epratuzumab - Rate of MRD negativity prior to SCT with Arm A vs. Arm B - Rate of MRD negativity prior to SCT after consolidation with versus without epratuzumab - Pharmacokinetic of epratuzumab in context with arm A and arm B

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Contacts

Public ContactProf. dr. P.M. Hoogerbrugge

Prinses Máxima Centrum

trialmanagement@prinsesmaximacentrum.nl088 972 72 72

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)