B1931036 - A prospective, randomized, open-label phase 2 study to evaluate the superiority of Inotuzumab ozogamicin monotherapy versus ALLR3 for induction treatment of childhood high risk first relapse B-CELL precursor acute lymphoblastic leukaemia.

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: II Randomizzato

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Male or female participants between 1 and <18 years of age.
- Morphologically confirmed diagnosis of first relapse HR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary therapy, and lacking any identified very high-risk genetic abnormalities (ie, KMT2A-rearrangements, TCF3-HLF, TCF3-PBX1, hypodiploidy, TP53 alteration)
    - CD22-positive ALL as defined by local institution;
    - Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status).
- Adequate serum chemistry parameters:
    - An eGFR in participants 1 to <2 years of age, or eCrCl in those 2 to <18 years of age, ≥30 mL/min using the recommended formula in Section 10.10.2.
    - AST and ALT ≤5 × institutional ULN at the time of randomization or pre-cytoreduction/general anesthesia;
    - Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome;
- Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines.
- Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction >50% by MUGA.

Criteri di esclusione: 

- Any history of prior or ongoing hepatic SOS or prior liver failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)].
- Prior allo-HSCT or CAR T-cell therapy.
- Isolated extramedullary leukemia.
- Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present.
- Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin).
- Participants with active, uncontrolled bacterial, fungal, or viral infection.

Numero di pazienti previsti: 

15

Schema di trattamento: 

Each participant in the InO arm will receive 1 course (3 doses) of InO, as follows:
Day 1: 0.8 mg/m2
Days 8 (±1 day) and Day 15 (±1 day): 0.5 mg/m2/dose

Mitoxantrone 10 mg/m2 on Days 1 and 2 Vincristine 1.5 mg/m2 (max single dose 2 mg) administered on Days 3, 10, 17 and 24 Dexamethasone 20 mg/m2/day administered orally (or IV) divided into two daily doses (maximum 40 mg/day) as two 5-day blocks on Days 1-5 and Days 15-19.
PEG-asparaginase 1000 units/m2 IV administered on Days 3 and 17.

Trattamento sperimentale: 

Inotuzumab ozogamicin

Trattamento di controllo: 

ALLR3

Obiettivi primari dello studio: 

Minimum Residual Disease (MRD) Negativity in participants achieving complete response (CR), complete response with incomplete platelet count recovery (CRp), or complete response with incomplete count recovery (CRi).

Data di inizio dell'arruolamento: 25.05.2023

Data di fine dell'arruolamento: 15.05.2026

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-000186-40

Data di inserimento: 10.10.2023

Promotore

Pfizer

CRO

SYNEOS HEALTH

Principal Investigator ITALIA

Riferimento: Dr. Informazione non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd