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

Launched by PFIZER · Feb 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Inotuzumab Ozogamicin (InO) to see how well it works for children and teenagers aged 1 to under 18 who have a type of leukemia called acute lymphoblastic leukemia (ALL) that has come back after treatment. The goal is to find out if InO is better than the standard treatment after the first round of therapy. The study will also look at how safe the medication is, how it works in the body, and how well it helps in the long term. Participants will receive treatment and then be followed for up to 5 years to monitor their progress.

To be eligible for this trial, children must have been diagnosed with a specific type of relapsed ALL and meet certain health criteria, such as having enough healthy kidney function. They should not have had certain other treatments or serious liver problems in the past. If a child joins the study, they can expect to receive either the new medication or the standard treatment and will be closely monitored throughout the process. This study is currently recruiting participants, so families can reach out to find out if they qualify.

Gender

ALL

Eligibility 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 (Groeneveld-Krentz et al, 2019) (ie, KMT2A::AFF1 fusion \[t(4;11)(q21;q23)\], TCF3-HLF fusion \[t(17;19)(q22;p13)\], TCF3-PBX1 fusion \[t(1;19)(q23;p13.3)\], hypodiploidy \[\<40 chromosomes\] or masked low hypodiploidy (Molina et al, 2021), 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.
• • 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.
• • 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.
• • 7. Hypersensitivity/allergy to both PEG-ASP and Erwinia-ASP