12 and older, any sex, with CD22 Positive or Recurrent Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants to Achieve Complete Remission (CR)Primary· Up to 2 years
Complete Remission (CR) is the normalization of the peripheral blood and bone marrow with \</= 5% blasts with a granulocyte count of 1X10\^9/L or above and a platelet count of \>/= 100X10\^9/L and absence of extramedullary disease.
Group
Value
95% CI
Treatment (Inotuzumab Ozogamicin)
3
Participants With a Grade 3 or 4 Non-hematologic Adverse Event (AE)Secondary· Up to 2 years
For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting.
Group
Value
95% CI
Treatment (Inotuzumab Ozogamicin)
1
Duration of ResponseSecondary· Up to 3 years
The date of Complete Response to the date of loss of response or last follow-up.
Group
Value
95% CI
Treatment (Inotuzumab Ozogamicin)
17.0
11.1 – 31.8
Progression Free SurvivalSecondary· Up to 3 years
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Group
Value
95% CI
Treatment (Inotuzumab Ozogamicin)
11.7
0.4 – 32.7
Overall SurvivalSecondary· Up to 3 years
Time from date of treatment start until date of death due to any cause or last Follow-up.
Group
Value
95% CI
Treatment (Inotuzumab Ozogamicin)
19.6
1.5 – 32.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 2 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well inotuzumab ozogamicin works in treating patients with CD22 positive acute lymphoblastic leukemia that has come back or does not respond to treatment. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06287229 — Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients
· Phase 1, PHASE2
· recruiting
NCT06087419 — A Prospective Clinical Study of Bridging alloHSCT After Treatment With Obinutuzumab in Combination With Chidamide and Ve
· Phase 1, PHASE2
· unknown
NCT05597085 — A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again
· completed
NCT05940961 — Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL
· Phase 2
· recruiting
NCT07238907 — A Multi-center Retrospective Study of INO Treating B-ALL
· active not recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 12 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03094611.