A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL

• Status: Not yet recruiting
• Trial end date: 2027-10-13
• Target enrollment: 0
• Participant gender: All

Summary

This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Inotuzumab Ozogamicin

Criteria

Inclusion Criteria:

1. Male or female participants between 1 and <18 years of age.

2. 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).

3. 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;

4. Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines.

5. Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction >50% by MUGA.

5.2. Exclusion Criteria

1. 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)].

2. Prior allo-HSCT or CAR T-cell therapy.

3. Isolated extramedullary leukemia.

4. Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present.

5. Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin).

6. Participants with active, uncontrolled bacterial, fungal, or viral infection.