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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03913559
The ClinicalTrials.gov registry entry for NCT03913559 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cytarabine is the first listed.
NCT03913559 reports 0 study locations.
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.
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