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Monoclonal Antibodies

Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Phase 2

Recruiting

Led By Sima Jeha, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Leukemia blasts demonstrating surface expression of CD22

At least 42 days must have elapsed since CAR-T cell therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days from last dose of inotuzumab ozogamicin or up to 30 days post-transplant among the patients who proceed to transplant

Awards & highlights

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).

Who is the study for?

This trial is for children under 22 with B-lymphoblastic leukemia showing CD22 expression and persistent or rising MRD between 0.1% and 4.99%. They must have tried at least two prior treatments, may have had one bone marrow transplant, need proper liver and kidney function, no severe concurrent conditions, not pregnant or breastfeeding, and agree to use contraception.Check my eligibility

What is being tested?

The study tests inotuzumab ozogamicin (Besponsa) effectiveness in pediatric patients with MRD positive CD22-positive B-ALL who still have a small number of leukemia cells after treatment. It aims to see if this drug can help achieve undetectable levels of these cells.See study design

What are the potential side effects?

Potential side effects include liver toxicity and sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD), especially following stem cell transplants. Other common reactions might be infusion-related like fever or chills, as well as possible blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia cells show CD22 on their surface.

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It has been more than 42 days since my CAR-T cell therapy.

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I am younger than 22 years old.

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My kidneys work well enough for my age.

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It's been over a week since my last biological treatment.

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I have B-ALL with specific MRD levels and no disease outside the bone marrow after multiple treatments.

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My liver tests are within normal limits.

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I have had one or no bone marrow transplants.

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It's been over 90 days since my bone marrow transplant, and I've been off immune suppression for at least 2 weeks without signs of GVHD.

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My heart is strong enough, with good pumping ability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days from last dose of inotuzumab ozogamicin or up to 30 days post-transplant among the patients who proceed to transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days from last dose of inotuzumab ozogamicin or up to 30 days post-transplant among the patients who proceed to transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days from last dose of inotuzumab ozogamicin or up to 30 days post-transplant among the patients who proceed to transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment Response Cycle 1 - percentage

Treatment Response Cycle 2 - count

Treatment Response Cycle 2 - percentage

+1 more

Secondary outcome measures

Occurrence of Veno-occlusive disease (VOD) - count

Occurrence of Veno-occlusive disease (VOD) - percentage

Occurrence of death - count

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Inotuzumab ozogamicinExperimental Treatment7 Interventions

Experimental: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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methotrexate

2013

Completed Phase 4

~3800

Hydrocortisone

2005

Completed Phase 4

~1260

Cytarabine

2016

Completed Phase 3

~3310

Diphenhydramine

2002

Completed Phase 4

~1170

Acetaminophen

2017

Completed Phase 4

~2030

Methylprednisolone

2015

Completed Phase 4

~2280

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,581 Total Patients Enrolled

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,915,994 Total Patients Enrolled

Sima Jeha, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

8 Previous Clinical Trials

923 Total Patients Enrolled

Media Library

Inotuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03913559 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Inotuzumab ozogamicin

Acute Lymphoblastic Leukemia Clinical Trial 2023: Inotuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT03913559 — Phase 2

Inotuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03913559 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being admitted to this trial at this time?

"Yes, this trial is still recruiting patients. The original posting was on May 14th, 2019, with the most recent update being on October 24th, 2022."

Answered by AI

For what reasons is Diphenhydramine commonly prescribed?

"Diphenhydramine is often used as a pain medication. This drug can also help treat other conditions such as ulcerative colitis, varicella-zoster virus acute retinal necrosis, and hematopoietic stem cells."

Answered by AI

Does the FDA sanction Diphenhydramine for public use?

"While there is some evidence for Diphenhydramine's safety, it did not receive a score of 3 because there is no data currently supporting its efficacy in Phase 2 trials."

Answered by AI

What are the goals that researchers hope to achieve with this study?

"Pfizer, the trial sponsor, reports that the primary outcome of this study will be treatment response cycle 1 - count. Secondary outcomes being assessed include occurrence of death - percentage, occurrence of Veno-occlusive disease (VOD) - count, and occurrence of Veno-occlusive disease (VOD) - percentage."

Answered by AI

How many people will be given the opportunity to participate in this clinical trial?

"That is accurate. The information available on clinicaltrials.gov affirms that the trial is still looking for volunteers. This experiment was first advertised on May 14th, 2019 and was last updated on October 24th, 2022. At the moment, they are only 32 slots open at a single location."

Answered by AI

Recent research and studies

HematologyJournal

Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia

Shi, Zheng, Yiqian Zhu, Jing Zhang, and Baoan Chen. 2022. “Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia”. Hematology. Informa UK Limited. doi:10.1080/16078454.2022.2074704.

HematologyJournal

Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia

clinicaltrials.govStudy

Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia

2019. "Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03913559.