25 Participants Needed

Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

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Overseen ByCancer Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow limited prior treatment with corticosteroids or hydroxyurea. Medications known to cause heart rhythm issues (Torsades de Pointes) are not allowed during the study.

Is Inotuzumab Ozogamicin safe for humans?

Inotuzumab Ozogamicin has been shown to be generally well-tolerated in patients with acute lymphoblastic leukemia, but it can cause some side effects, including liver-related issues like veno-occlusive disease (a condition where small veins in the liver are blocked) and sinusoidal obstruction syndrome (a blockage of small veins in the liver).12345

How is the drug Inotuzumab Ozogamicin different from other treatments for acute lymphoblastic leukemia?

Inotuzumab Ozogamicin is unique because it is a targeted therapy that uses a monoclonal antibody to deliver a toxic agent directly to cancer cells expressing CD22, which is present in over 90% of acute lymphoblastic leukemia cases. This approach allows for more precise targeting of cancer cells compared to traditional chemotherapy, potentially improving outcomes for patients with relapsed or refractory disease.26789

What data supports the effectiveness of the drug Inotuzumab Ozogamicin for treating acute lymphoblastic leukemia?

Inotuzumab Ozogamicin has shown to improve response rates, survival, and the ability to proceed to stem cell transplants in patients with relapsed or refractory acute lymphoblastic leukemia compared to standard chemotherapy. It is a promising therapy that targets specific cancer cells, leading to better outcomes for patients who have not responded to other treatments.2361011

Who Is on the Research Team?

Wendy Stock, MD - UChicago Medicine

Wendy Stock, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

A patient is of childbearing potential if, in the opinion of the treating investigator, he/she is biologically capable of having children and is sexually active
My leukemia involves more than 20% lymphoblasts in my bone marrow or blood, confirmed by specific genetic tests.
My organs are functioning well according to my medical records.
See 8 more

Exclusion Criteria

My leukemia has spread to my brain or spinal cord.
History of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse
I am not taking any medications that can cause heart rhythm problems.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Phase

Participants receive inotuzumab ozogamicin combined with anti-cancer drugs for induction therapy

4 weeks
Weekly visits for drug administration

Consolidation Phase

Continuation of treatment with inotuzumab ozogamicin and anti-cancer drugs based on response to induction

4 weeks
Weekly visits for drug administration

Interim/Maintenance Phase

Participants receive maintenance treatment with dasatinib and other drugs, with inotuzumab ozogamicin added in the fourth course

12-24 weeks
Monthly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Inotuzumab ozogamicin
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Treatment Arm - Interim/Maintenance Phase - Participants in CMRExperimental Treatment7 Interventions
Group II: Treatment Arm - Interim/Maintenance Phase - Participants Not in CMRExperimental Treatment7 Interventions
Group III: Treatment Arm - Induction/Consolidation Phase - All ParticipantsExperimental Treatment4 Interventions

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

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Approved in United States as Besponsa for:
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Approved in European Union as Besponsa for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Published Research Related to This Trial

Inotuzumab ozogamicin, a CD22-targeting antibody-drug conjugate, has been approved for treating adults with relapsed or refractory acute lymphoblastic leukemia (ALL) and shows improved response rates and survival compared to standard chemotherapy.
This treatment not only enhances the chances of achieving minimal residual disease negativity but also increases the likelihood of patients being eligible for allogeneic stem cell transplants, which can be crucial for their long-term outcomes.
Inotuzumab Ozogamicin in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.Williams, S., Kim, M.[2020]
Inotuzumab ozogamicin, a targeted therapy for relapsed/refractory acute lymphoblastic leukemia, effectively binds to CD22, which is present in 90-100% of malignant B-lymphocytes, showing promise for patients who have undergone extensive prior treatments.
The therapy is generally well-tolerated, although there is a risk of veno-occlusive disease, making it a potentially beneficial option for patients seeking allogeneic stem cell transplants.
Role of inotuzumab ozogamicin in the treatment of relapsed/refractory acute lymphoblastic leukemia.George, B., Kantarjian, H., Jabbour, E., et al.[2019]
Inotuzumab ozogamicin (InO) demonstrated superior clinical activity compared to standard-of-care treatments in patients with relapsed/refractory B-cell acute lymphoblastic leukemia, as shown in the phase 3 INO-VATE trial.
Patients receiving InO reported significantly better quality of life and functioning scores compared to those on standard-of-care, indicating a favorable benefit/risk ratio for InO in this patient population.
Patient-reported outcomes from a phase 3 randomized controlled trial of inotuzumab ozogamicin versus standard therapy for relapsed/refractory acute lymphoblastic leukemia.Kantarjian, HM., Su, Y., Jabbour, EJ., et al.[2019]

Citations

Inotuzumab Ozogamicin in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. [2020]
Role of inotuzumab ozogamicin in the treatment of relapsed/refractory acute lymphoblastic leukemia. [2019]
Patient-reported outcomes from a phase 3 randomized controlled trial of inotuzumab ozogamicin versus standard therapy for relapsed/refractory acute lymphoblastic leukemia. [2019]
Inotuzumab ozogamicin: a CD22 mAb-drug conjugate for adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia. [2019]
Inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia. [2019]
Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. [2019]
Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. [2022]
Hepatic adverse event profile of inotuzumab ozogamicin in adult patients with relapsed or refractory acute lymphoblastic leukaemia: results from the open-label, randomised, phase 3 INO-VATE study. [2022]
Inotuzumab ozogamicin for the treatment of patients with acute lymphocytic leukemia. [2019]
Inotuzumab ozogamicin in the treatment of B-cell acute lymphoblastic leukemia. [2022]
Inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia. [2021]
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