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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 belowSelect...
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:Select...
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
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 moreAwards & 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
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.
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.
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,057 Previous Clinical Trials
763,606 Total Patients Enrolled
Wendy Stock, MDPrincipal InvestigatorUniversity of Chicago
8 Previous Clinical Trials
1,325 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia involves more than 20% lymphoblasts in my bone marrow or blood, confirmed by specific genetic tests.My leukemia has spread to my brain or spinal cord.My organs are functioning well according to my medical records.I am not taking any medications that can cause heart rhythm problems.I am newly diagnosed with a specific leukemia type and have not started treatment.I do not have any serious infections or recent deep tissue infections.I do not have any severe or uncontrolled health issues.My cancer is located outside the bone marrow.I have a heart condition that is not well-managed.I am 18 years old or older.I am a woman who cannot become pregnant due to surgery or menopause.I am not pregnant or breastfeeding, and if I can have children, I agree to use effective birth control during and after the trial.I have no active cancer except for certain skin, cervical, or treated prostate cancers.I have hepatitis B, hepatitis C, or HIV but my viral load is undetectable.My condition is either Burkitt's or mixed-lineage leukemia.I have only had minimal treatment for ALL, except possibly steroids for other conditions.I have not had major surgery in the last 2 weeks.I have recovered from any major side effects of recent surgery, radiation, or clinical trials.I can take care of myself and am up and about more than half of my waking hours.I have had liver-related blockage issues in the past.I will use effective birth control during and for 5 months after my Inotuzumab Ozogamicin treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm - Induction/Consolidation Phase - All Participants
- Group 2: Treatment Arm - Interim/Maintenance Phase - Participants Not in CMR
- Group 3: Treatment Arm - Interim/Maintenance Phase - Participants in CMR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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