Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen by Wendy Stock, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Chicago

Must not be taking: Torsades de Pointes

Disqualifiers: CNS leukemia, Hepatitis B/C, HIV, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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). ^{1 2 6 7 8}

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. ^{2 4 9 10 11}

Research Team

Wendy Stock, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• Inotuzumab ozogamicin (Monoclonal Antibodies)

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.

Participant Groups

Group I: Treatment Arm - Interim/Maintenance Phase - Participants in CMR Experimental Treatment 7 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 CMR Experimental Treatment 7 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 Participants Experimental Treatment 4 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Chicago Medical Center Chicago, IL

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1086

Patients Recruited

844,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inotuzumab Ozogamicin in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. Williams, S., Kim, M.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of inotuzumab ozogamicin in the treatment of relapsed/refractory acute lymphoblastic leukemia. George, B., Kantarjian, H., Jabbour, E., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin: a CD22 mAb-drug conjugate for adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Yurkiewicz, IR., Muffly, L., Liedtke, M.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia. Tvito, A., Rowe, JM.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. Jabbour, EJ., DeAngelo, DJ., Stelljes, M., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. Fujishima, N., Uchida, T., Onishi, Y., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kantarjian, HM., DeAngelo, DJ., Advani, AS., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin for the treatment of patients with acute lymphocytic leukemia. Choudhry, A., O'Brien, SM.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin in the treatment of B-cell acute lymphoblastic leukemia. Thomas, X.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia. Savoy, JM., Welch, MA., Nasnas, PE., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Inotuzumab Ozogamicin in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Role of inotuzumab ozogamicin in the treatment of relapsed/refractory acute lymphoblastic leukemia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes from a phase 3 randomized controlled trial of inotuzumab ozogamicin versus standard therapy for relapsed/refractory acute lymphoblastic leukemia. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin: a CD22 mAb-drug conjugate for adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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]

9. Spain pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin for the treatment of patients with acute lymphocytic leukemia. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin in the treatment of B-cell acute lymphoblastic leukemia. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia. [2021]