Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Recruiting at 1 trial location

Overseen By Sima C. Jeha

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: St. Jude Children's Research Hospital

Must not be taking: Chemotherapy, Targeted agents

Disqualifiers: SOS/VOD, HIV, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: up to 24 weeks

32 Participants Needed

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).

Research Team

Sima Jeha, MD

Principal Investigator

St. Jude Children's Research Hospital

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 kidneys work well enough for my age.

My leukemia cells show CD22 on their surface.

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

Exclusion Criteria

I agree to use birth control during and for 30 days after the study.

Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inotuzumab ozogamicin intravenously on days 1, 8, and 15 of each 28-day cycle, with up to six cycles possible

up to 24 weeks

3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

1 year

Treatment Details

Interventions

• Inotuzumab Ozogamicin

Trial Overview 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.

Participant Groups

Group I: Inotuzumab ozogamicin Experimental Treatment 7 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:

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Approved in United States as Besponsa for:

• Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University