The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active enrolling
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland
for more information at clinicaltrials.gov
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
DRUG: Inotuzumab ozogamicin
Inotuzumab ozogamicin 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.
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. In case of hypersensitivity/allergic reaction to PEG-asparaginase, each dose of PEG-asparaginase will be replaced by Erwinia-asparaginase at a dose of 20,000 units/m² IV or IM every other day for a total of 6 doses
DRUG: ALLR3
The ALLR3 chemotherapy regimen (vincristine, mitoxantrone, dexamethasone, and PEG-asparaginase [or erwinia-asparaginase in the event of an allergic reaction to PEG-asparaginase]) has been adopted by pediatric oncology groups as treatment for pediatric relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL)
6 Participants with combined bone marrow and testicular relapse are eligible assuming orchiectomy is performed prior to randomization or is planned at the end of induction therapy.
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)
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
After 1 treatment cycle: Day 28 +/- 2 days
Event Free Survival (EFS)
EFS will be summarized using Kaplan-Meier methods and displayed graphically by treatment arm.
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
Duration of Response (DoR) for Participants Who Achieved CR/CRp/CRi
DoR will be summarized using Kaplan-Meier methods.
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
Rate of hematopoietic stem cell transplantation (HSCT)
HSCT rate will be summarized by descriptive analyses (ie, percentage of participants who underwent HSCT after treatment).
Up to 5 years from randomization
Overall Survival (OS)
OS will be summarized by treatment arm using Kaplan-Meier methods.
From start of treatment to date of death due to any cause: up to 5 years from randomization
Number of participants reporting an Adverse Event (AE)
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.
From time of informed consent up to a minimum of 60 calendar days after the last dose of study drug.
Pharmacokinetics (PK) parameter: InO Cmax
Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits.
1 treatment cycle: 28 days
Number of Adverse Events (AE) reported by severity
AEs will be graded by the investigator according to the CTCAE (Common Terminology Criteria for Adverse Events) version 4.03.
From time of informed consent up to a minimum of 60 calendar days after the last dose of study drug.
Pharmacokinetics (PK) parameter: InO trough levels
Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits.
1 treatment cycle: 28 days
Rate of Chimeric antigen receptor (CAR) T-cell therapy
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).
Up to 5 years from randomisation
100
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT05748171
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