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NCT03913559 · ClinicalTrials.gov registry record · Phase 2
Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT03913559: Clinical Trial Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT03913559 is a Phase 2 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03913559, a Phase 2 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This trial is a limited multi-center, Phase II study to evaluate inotuzumab ozogamicin (Besponsa) in pediatric patients with MRD positive CD22-positive B-lymphoblastic leukemia (B-ALL). Some patients with newly diagnosed ALL maintain low levels of MRD, despite achieving complete remission with less than 5% blasts in the bone marrow. Others experience re-emergence of low level MRD or increasing levels of MRD on therapy or post-transplant. New approaches are needed to achieve undetectable MRD in these high-risk patients. Inotuzumab ozogamicin is an antibody-drug conjugate composed of a humanized IgG subtype 4 monoclonal CD22-targeted antibody linked to calicheamicin, a potent anti-tumor antibiotic. CD22 is expressed in more than 90% of patients with B-cell ALL, making it an attractive target in this patient population. Inotuzumab ozogamicin has demonstrated exceptional activity in adults with relapsed or refractory B-ALL. Primary Objective * Assess the efficacy of inotuzumab ozogamicin in patients with MRD positive CD22+ B-ALL with 0.1 - 4.99% blasts in bone marrow. Secondary Objectives * Study the safety of inotuzumab ozogamicin when used in patients with MRD - positive CD22+ B-ALL with \< 5 % blasts in bone marrow. * Estimate the incidence, severity, and outcome of hepatotoxicity and sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) in patients during inotuzumab ozogamicin and following subsequent treatment, including hematopoietic stem cell transplant (HSCT).
Primary Outcome
Number of patients that reach MRD negative at the end of cycle 1
Interventions
- DRUG Cytarabine
- DRUG Diphenhydramine
- DRUG Methotrexate
- DRUG Hydrocortisone
- DRUG Inotuzumab ozogamicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-05-14 |
| Est. Completion | 2025-09-15 |
| Phase | Phase 2 |
Why NCT03913559 stopped before completion
NCT03913559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which Cytarabine is the first listed.
NCT03913559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03913559 about?
NCT03913559 is a clinical study titled "Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia". This trial is a limited multi-center, Phase II study to evaluate inotuzumab ozogamicin (Besponsa) in pediatric patients with MRD positive CD22-positive B-lymphoblastic leukemia (B-ALL). Some patients with newly diagnosed ALL maintain low levels of MRD, despite achieving complete remission with less...
What is the current status of trial NCT03913559?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2019-05-14. Estimated completion is 2025-09-15.
What interventions are being tested in trial NCT03913559?
The interventions under investigation include: Cytarabine (DRUG), Diphenhydramine (DRUG), Methotrexate (DRUG), Hydrocortisone (DRUG), Inotuzumab ozogamicin (DRUG).
Who is sponsoring clinical trial NCT03913559?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03913559's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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