Study Stopped
Closed due to slow accrual
Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia
2 other identifiers
interventional
5
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2019
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2019
CompletedFirst Posted
Study publicly available on registry
April 12, 2019
CompletedStudy Start
First participant enrolled
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2025
CompletedFebruary 12, 2026
February 1, 2026
6.3 years
April 9, 2019
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Treatment response Cycle1 - count
Number of patients that reach MRD negative at the end of cycle 1
At the end of cycle 1 (each cycle is 28 days)
Treatment Response Cycle 1 - percentage
Percentage of patients that reach MRD negative at the end of cycle 1
At the end of cycle 1 (each cycle is 28 days)
Treatment Response Cycle 2 - count
Number of patients that reach MRD negative at the end of cycle 2
At the end of cycle 2 (each cycle is 28 days)
Treatment Response Cycle 2 - percentage
Percentage of patients that reach MRD negative at the end of cycle 2
At the end of cycle 2 (each cycle is 28 days)
Secondary Outcomes (4)
Occurrence of death - count
up to 30 days from last dose of inotuzumab ozogamicin or up to 30 days post-transplant among the patients who proceed to transplant
Occurrence of death - percentage
up to 30 days from last dose of inotuzumab ozogamicin or up to 30 days post-transplant among the patients who proceed to transplant
Occurrence of Veno-occlusive disease (VOD) - count
up to 30 days from last dose of inotuzumab ozogamicin or up to 30 days post-transplant among the patients who proceed to transplant
Occurrence of Veno-occlusive disease (VOD) - percentage
up to 30 days from last dose of inotuzumab ozogamicin or up to 30 days post-transplant among the patients who proceed to transplant
Study Arms (1)
Inotuzumab ozogamicin
EXPERIMENTALExperimental:Inotuzumab Ozogamicin (InO) Patients with B cell acute lymphoblastic leukemia (B-ALL) that is showing early signs of relapsing (coming back) or is not responding to treatment (refractory). Interventions:methotrexate, hydrocortisone and cytarabine into the central nervous system (called triple intrathecal chemotherapy or IT chemotherapy) during this study. Premedication: diphenhydramine, acetaminophen and methylprednisolone
Interventions
dose: 0.5 mg/m2 IV over 60 minutes, days: 1, 8 and 15 every 4 weeks (28 days per cycle) for up to 6 cycles.
Eligibility Criteria
You may qualify if:
- Age
- Participants must be \< 22 years of age.
- Diagnosis
- Participants must have B-ALL with persistent or rising MRD between 0.1 and 4.99% without extramedullary disease following at least two prior induction attempts, relapse or after hematopoietic stem cell transplant
- Leukemia blasts demonstrating surface expression of CD22
- Performance Level
- Karnofsky or Lansky performance score ≥ 50% (corresponding to ECOG Score of ≥ 2). The Lansky performance score should be used for participants \< 16 years and the Karnofsky performance score for participants ≥ 16 years.
- Prior Therapy
You may not qualify if:
- At least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of standard maintenance therapy and steroids.
- At least 7 days must have elapsed since completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur.
- At least 42 days must have elapsed since CAR-T cell therapy.
- Participant has received ≤ 1 prior bone marrow transplant.
- At least 90 days have elapsed since bone marrow transplant and participant is off immune suppression for ≥ 2 weeks, if applicable with no evidence of active GVHD.
- At least 2 weeks must have elapsed since local XRT (small port); ≥ 3 months must have elapsed if prior cranial or craniospinal XRT was received, if ≥ 50% of the pelvis was irradiated, or if TBI was received; ≥ 6 weeks must have elapsed if other substantial bone marrow irradiation was given.
- Organ Function Requirements
- Adequate renal function defined as glomerular filtration rate ≥ 60 cc/min/1.73m2 or serum creatinine based on age as follows:
- Age: \<6 months; maximum serum creatinine (mg/dL): 0.4 (male, female); Age: 6 months to \<1 year; maximum serum creatinine (mg/dL): 0.5 (male, female); Age: 1 to \< 2 years; maximum serum creatinine (mg/dL): 0.6 (male, female); Age: 2 to \< 6 years; maximum serum creatinine (mg/dL): 0.8 (male, female); Age: 6 to \<10 years; maximum serum creatinine (mg/ dL): 1 (male, female); Age: 10 to \<13 years; maximum serum creatinine (mg/dL): 1.2 (male, female); Age: 13 to \<16 years; maximum serum creatinine (mg/dL): 1.5 (male), 1.4 (female); Age: ≥ 16 years; maximum serum creatinine (mg/dL): 1.7 (male), 1.4 (female)
- Adequate hepatic function defined as:
- Direct bilirubin ≤ 1.4 mg/dL (if total bilirubin \> 1.4 mg/dL) and
- AST or ALT ≤ 3 x ULN for age.
- Adequate cardiac function defined as shortening fraction of ≥ 27% or ejection fraction ≥ 45%.
- History of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of any severity.
- Concurrent chemotherapy or targeted anti-cancer agents, other than intrathecal therapy.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Jude Children's Research Hospitallead
- Pfizercollaborator
Study Sites (2)
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Publications (1)
Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.
PMID: 35622074DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sima Jeha, MD
St. Jude Children's Research Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2019
First Posted
April 12, 2019
Study Start
May 14, 2019
Primary Completion
September 15, 2025
Study Completion
September 15, 2025
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.