Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen BySima Jeha, MD

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: St. Jude Children's Research Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

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.

Inclusion Criteria

My leukemia cells show CD22 on their surface.

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

I am younger than 22 years old.

My kidneys work well enough for my age.

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

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

My liver tests are within normal limits.

I have had one or no bone marrow transplants.

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.

My heart is strong enough, with good pumping ability.

Exclusion Criteria

I have had a condition where small veins in my liver were blocked.

I have HIV or active hepatitis B or C.

I am not on any cancer treatments except for intrathecal therapy.

Participant Groups

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.

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

Inotuzumab Ozogamicin is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Besponsa for: