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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NCT05748171 · readout in 2,467 d

Sponsored by Pfizer (industry) · PFE — their whole pipeline →.

Phase

Phase 2

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

100estimated

Sites

Countries

Austria, Belgium, Czechia +13

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-05-17

actual

When the study began enrolling

Primary completion

2033-05-21

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2036-05-25

estimated

The whole study's end, after follow-up

First posted

2023-02-28

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

ACUTE LYMPHOBLASTIC LEUKEMIA

Interventions

Drug: Inotuzumab ozogamicin — also filed as Besponsa
Drug: ALLR3 — also filed as R3

Primary outcome

what the primary-completion date above is the date OF

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)

measured After 1 treatment cycle: Day 28 +/- 2 days

Publications

PMID 41671463 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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