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

Phase 2

• Conditions: Relapsed Acute Lymphoblastic Leukemia and Relapsed Childhood leukemia; 10024324

• Registration Number: NL-OMON53624
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

Participants must meet the following key inclusion criteria to be eligible for
enrollment into the study:
1. Male or female participants between 1 and <18 years of age.
2. Morphologically confirmed diagnosis of first relapse HR BCP ALL:
• CD22-positive ALL as defined by local institution.
• Bone marrow involvement of >= 5% leukemic blasts (>= M2 status).
3. Cardiac shortening fraction >= 30% by echocardiogram or ejection fraction >
50% by MUGA.

Exclusion Criteria

Participants with any of the following key characteristics/conditions will be
excluded:
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary:<br /><br>Efficacy: To demonstrate the superiority of InO monotherapy vs ALLR3 induction<br /><br>in paediatric participants between 1 and <18 years with HR first bone marrow<br /><br>relapse CD22-positive BCP ALL<br /><br>Endpoints: MRD-negative, CR/CRp/CRi (per investigator assessment) at the end of<br /><br>induction therapy (MRD negativity is assessed by central lab and defined as<br /><br>leukemic blasts <1x10-4 by RQ-PCR [with reflex to FC result if MRD is<br /><br>non-evaluable by RQ-PCR]).<br /><br>Estimands: The treatment effect in the targeted population of InO monotherapy<br /><br>assessed by the MRD negative CR/CRp/CRi rate, based on investigator assessment<br /><br>per modified NCCN criteria (Section 10.12 of the full protocol) vs ALLR3<br /><br>induction from the date of randomization to EOT. </p><br>