What side effects are associated with this type of intervention?

Common treatments for Acute Lymphoblastic Leukemia (ALL), such as Inotuzumab Ozogamicin, which targets CD22-positive B-cells, often have side effects including hepatotoxicity, infusion-related reactions, and myelosuppression. Patients may experience liver enzyme abnormalities, veno-occlusive disease, fever, chills, and low blood cell counts leading to increased risk of infections, anemia, and bleeding. Other general side effects of ALL treatments can include nausea, fatigue, and mucositis.

What prior FDA approvals exist?

Inotuzumab Ozogamicin is an FDA-approved treatment for relapsed or refractory CD22-positive B-cell Acute Lymphoblastic Leukemia (ALL). It is an antibody-drug conjugate that targets CD22 on B-cells and delivers a cytotoxic agent to kill the cancer cells. Similar treatments include Blinatumomab, a bispecific T-cell engager that targets CD19 on B-cells, and Tisagenlecleucel, a CAR-T cell therapy also targeting CD19. These therapies have been approved for their ability to target specific antigens on B-cells and deliver cytotoxic effects, providing new options for patients with relapsed or refractory ALL.

What other types of research exist?

Promising novel alternatives to Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia (ALL) patients include: 1. Blinatumomab: A bispecific T-cell engager (BiTE) that targets CD19 on B-cells and CD3 on T-cells, facilitating T-cell-mediated cytotoxicity against leukemia cells. 2. CAR-T cell therapy (e.g., Tisagenlecleucel): Chimeric Antigen Receptor T-cell therapy targeting CD19, which has shown significant efficacy in relapsed/refractory ALL. 3. Venetoclax: A BCL-2 inhibitor that promotes apoptosis in leukemia cells, often used in combination with other agents. 4. Ponatinib: A tyrosine kinase inhibitor effective against Philadelphia chromosome-positive ALL, particularly in cases resistant to other TKIs.

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Monoclonal Antibodies

Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Phase 2

Recruiting

Led By Wendy Stock, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Must be a newly diagnosed and untreated patient with Ph+ B-cell Acute Lymphoblastic Leukemia and CD22 expression on ≥20% of blasts

18 years old or older

Must not have

Active central nervous system (CNS) leukemia

Medications known to predispose to Torsades de Pointes are prohibited throughout the treatment period of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding the drug inotuzumab ozogamicin to the usual treatment can help patients with a specific type of leukemia (Ph+ ALL) achieve remission faster. The study focuses on patients who are beginning their treatment. Inotuzumab ozogamicin is a medication approved for certain types of leukemia.

Who is the study for?

This trial is for adults with newly diagnosed Philadelphia chromosome-positive (Ph+) B-cell Acute Lymphoblastic Leukemia. Participants must have CD22 expression on their cancer cells, be in good physical condition as measured by ECOG status, and have proper organ function. Pregnant or breastfeeding individuals are excluded, as well as those with severe medical conditions, certain heart issues, liver disease, active infections or other cancers.

What is being tested?

The study tests whether adding Inotuzumab Ozogamicin (InO) to standard induction therapy leads to quicker complete molecular remission in Ph+ ALL patients who haven't been treated before. It aims to improve the effectiveness of initial treatment by using this additional anti-cancer drug.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to InO such as fever and chills during infusion; blood-related issues like low platelet count; liver problems; and an increased risk of infection due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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I am newly diagnosed with a specific leukemia type and have not started treatment.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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I will use effective birth control during and for 5 months after my Inotuzumab Ozogamicin treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My leukemia has spread to my brain or spinal cord.

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I am not taking any medications that can cause heart rhythm problems.

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I do not have any severe or uncontrolled health issues.

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My cancer is located outside the bone marrow.

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I have a heart condition that is not well-managed.

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My condition is either Burkitt's or mixed-lineage leukemia.

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I have not had major surgery in the last 2 weeks.

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I have had liver-related blockage issues in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Enter Complete Clinical Remission at 60 Days as Defined by Criteria Set By The International Scale

Secondary study objectives

Disease Control Rate Based on Number of Participants Who Respond to Treatment After 3 Months

Duration of Complete Response

Duration of Response

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Treatment Arm - Interim/Maintenance Phase - Participants in CMRExperimental Treatment7 Interventions

This study arm is for participants who no longer show any detectable signs of BCR-ABL1 (a cancer-causing gene) in response to the previous phase of induction/consolidation treatment (also known as being in "complete molecular remission" or CMR). Participants in this arm will receive 3 courses of interim/maintenance treatment using dasatinib combined with other anti-cancer drugs. Inotuzumab ozogamicin will be added during the fourth course of treatment. These treatments will be given in 28-day and 84-day cycles. If the participant achieves complete molecular remission (no signs of BCR-ABL gene) after 60 days (or more) of treatment, then the treating physician may take the participant off the study for allogenic stem cell transplantation surgery. If the participant does not undergo allogeneic stem cell transplantation after achieving complete molecular remission, they will complete 3 additional courses of maintenance treatment.

Group II: Treatment Arm - Interim/Maintenance Phase - Participants Not in CMRExperimental Treatment7 Interventions

This study arm is for participants whose cancer responded to induction/consolidation treatment, but still shows detectable signs of BCR-ABL1 (a cancer-causing gene), so they are not in complete molecular remission. Participants in this arm will receive 3 courses of treatment using ponatinib combined with other anti-cancer drugs. Inotuzumab ozogamicin will be added during the 4th treatment course. These treatments will be given in 28-day and 84-day cycles. If the participant achieves complete molecular remission (no signs of BCR-ABL gene) after 60 days (or more) of treatment, the treating physician may take the participant off the study for allogenic stem cell transplantation surgery. If the participant does not undergo allogeneic stem cell transplantation after achieving complete molecular remission (CMR), they will complete 3 additional courses of maintenance treatment. If the participant doesn't achieve CMR after 4th treatment course, they will be removed from the study.

Group III: Treatment Arm - Induction/Consolidation Phase - All ParticipantsExperimental Treatment4 Interventions

All participants in this arm will receive the same first round of treatment as part of induction/consolidation therapy. This treatment will use inotuzumab ozogamicin combined with anti-cancer drugs. The additional treatment that participants receive after this first round of treatment will vary based on the participant's response to induction therapy. This phase of treatment will last for 60 days. All participants in this arm will receive the following treatment: Treatment Course I (Induction Phase, 28 days): * Dasatinib 140mg daily continuous * Dexamethasone 10mg/m\^2 PO or IV Days 1-7 and Day 15-Day 22 * InO 0.8mg/m2 Day 8; 0.5mg/m2 D15, 0.5mg/m2 Day 22 * Intrathecal methotrexate 15mg Day 1, Day 28 Treatment Course II (Consolidation Phase, 28 days): * Dasatinib 140mg daily continuous * InO: If in CR/CRi 0.5mg/m2 Day 1, Day 8, Day 15; If not in CR/CRi 0.8mg/m2 on Day 1, 0.5mg/m2 Day 8 and Day 15 * Intrathecal methotrexate 15mg Day 1, Day 28

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Methotrexate

2019

Completed Phase 4

~4400

Dasatinib

2012

Completed Phase 3

~2320

Vincristine

2003

Completed Phase 4

~2970

Ponatinib

2015

Completed Phase 2

~830

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Acute Lymphoblastic Leukemia (ALL) include antibody-drug conjugates like inotuzumab ozogamicin, which targets CD22-positive B-cells and delivers a cytotoxic agent to kill cancer cells. Tyrosine kinase inhibitors (TKIs) such as imatinib and dasatinib target the BCR-ABL fusion protein in Philadelphia chromosome-positive ALL, blocking signals that promote cancer cell growth. Traditional chemotherapeutic agents like vincristine, methotrexate, and cytarabine disrupt cell division and DNA replication. These treatments are essential for ALL patients as they aim to eradicate leukemic cells, achieve remission, and reduce the risk of relapse.

Successful Salvage of Very Early Relapse in Pediatric Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin and HLA-haploidentical Peripheral Blood Stem Cell Transplantation With Posttransplant Cyclophosphamide.