Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial will study the effects of adding the anti-cancer drug InO to standard induction treatment for newly diagnosed Ph+ ALL patients in order to achieve quicker, complete molecular remission.
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.Check my eligibility
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.See study design
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.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I will use effective birth control during and for 5 months after my Inotuzumab Ozogamicin treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Enter Complete Clinical Remission at 60 Days as Defined by Criteria Set By The International Scale
Secondary outcome measures
Disease Control Rate Based on Number of Participants Who Respond to Treatment After 3 Months
Duration of Complete Response
Duration of Response
+4 moreTrial 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
~2590
Methotrexate
2013
Completed Phase 4
~3800
Dasatinib
2012
Completed Phase 3
~2320
Vincristine
2003
Completed Phase 4
~2910
Ponatinib
2015
Completed Phase 2
~820
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,752 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment now open for this clinical experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this study, which was initially advertised on March 2nd 2021, is currently seeking volunteers. 25 applicants are necessary from a single medical site."
Answered by AI
How many volunteers have taken part in this clinical experiment?
"Indeed, clinicaltrials.gov confirms that this research initiative is currently seeking volunteers; it was initially published on March 2nd 2021 and most recently modified on May 16th 2022. For now, 25 potential participants are being recruited from a single site."
Answered by AI
Are there adverse effects that accompany the utilization of Inotuzumab ozogamicin?
"The safety of Inotuzumab ozogamicin was determined to be a 2, as the clinical trial is in its second stage and has produced some evidence regarding safety but not efficacy."
Answered by AI
To what maladies is Inotuzumab ozogamicin commonly employed?
"Inotuzumab ozogamicin is regularly prescribed to treat synovitis. It can be a useful therapeutic tool for certain eye conditions, such as ophthalmia and branch retinal vein occlusion, as well as small cell lung cancer (sclc)."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger