1. 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) (Time Frame - After 1 treatment cycle: Day 28 +/- 2 days): MRD negativity status is determined based on the minimum MRD percentage between the date of CR/CRp/CRi and end of treatment test as assessed by RQ-PCR, with reflex to FC result if MRD is non-evaluable by RQ-PCR
Secondary outcome:
1. Event Free Survival (EFS) (Time Frame - From study start to first event (progression, relapse, failure to achieve CR/CRp/CRi by the end of induction, MRD persistence prior to HSCT [hematopoietic stem cell transplant], second malignancy, or death): up to 5 years from randomization): EFS will be summarized using Kaplan-Meier methods and displayed graphically by treatment arm.
2. Duration of Response (DoR) for Participants Who Achieved CR/CRp/CRi (Time Frame - From date of first response to date of first event (objective progression, relapse as determined by investigator assessment, MRD persistence prior to HSCT, or death due to any cause, whichever occurs first): up to 5 years from End of Treatment): DoR will be summarized using Kaplan-Meier methods.
3. Rate of hematopoietic stem cell transplantation (HSCT) (Time Frame - Up to 5 years from randomization): HSCT rate will be summarized by descriptive analyses (ie, percentage of participants who underwent HSCT after treatment).
4. Overall Survival (OS) (Time Frame - From start of treatment to date of death due to any cause: up to 5 years from randomization): OS will be summarized by treatment arm using Kaplan-Meier methods.
5. Number of participants reporting an Adverse Event (AE) (Time Frame - From time of informed consent up to a minimum of 60 calendar days after the last dose of study drug.): The number and percentage of participants who experienced any AE, SAE (Serious Adverse Event), treatment related AE, and treatment related SAE will be summarized according to worst toxicity grades.
6. Pharmacokinetics (PK) parameter: InO Cmax (Time Frame - 1 treatment cycle: 28 days): Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits.
7. Number of Adverse Events (AE) reported by severity (Time Frame - From time of informed consent up to a minimum of 60 calendar days after the last dose of study drug.): AEs will be graded by the investigator according to the CTCAE (Common Terminology Criteria for Adverse Events) version 4.03.
8. Pharmacokinetics (PK) parameter: InO trough levels (Time Frame - 1 treatment cycle: 28 days): Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits.
9. Rate of Chimeric antigen receptor (CAR) T-cell therapy (Time Frame - Up to 5 years from randomisation): CAR T-cell therapy rate will be summarized by descriptive analyses (ie, the number, percent of participants who underwent CAR T-cell therapy after treatment).
Experimental: Inotuzumab ozogamicin 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
Active Comparator: ALLR3 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
Inotuzumab ozogamicin (Besponsa): Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved in several countries for the treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). The approved starting dose is 1.8mg/m2/cycle.
ALLR3 (R3): The ALLR3 chemotherapy regimen (vincristine, mitoxantrone, dexamethasone, and asparaginase) has been adopted by pediatric oncology groups as treatment for pediatric relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL)
Quelle: ClinicalTrials.gov
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"A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL"
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