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Monoclonal Antibodies
Venetoclax + Inotuzumab for Acute Lymphoblastic Leukemia
Phase 1
Recruiting
Led By Marlise R Luskin, MD, MSCE
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have ECOG performance status of 0-3
Participants with a known history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to end of treatment up to 9 months
Awards & highlights
Study Summary
This trial is studying how well venetoclax and inotuzumab ozogamicin work in combination in treating patients with acute lymphoblastic leukemia.
Who is the study for?
Adults with confirmed CD22+ B-ALL or B-LBL, including those with chronic myeloid leukemia in lymphoid blast crisis refractory to treatments. Must have adequate organ function, no severe liver disease, and agree to contraception. Excludes pregnant women, those on certain drugs affecting venetoclax metabolism, and individuals with uncontrolled illnesses.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of combining venetoclax with inotuzumab ozogamicin for treating acute lymphoblastic leukemia (ALL). Dexamethasone is also part of the treatment regimen. The goal is to see how well these drugs work together against ALL.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems. Liver issues could occur due to drug interactions or underlying conditions; close monitoring will be necessary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do active work.
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I have had hepatitis C but my current viral load is undetectable.
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I am 18 years old or older.
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I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.
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I can understand and sign the consent form.
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My cancer has returned or didn't respond after at least one chemotherapy treatment.
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My leukemia is confirmed to be CD22 positive.
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I have chronic hepatitis B but my viral load is undetectable.
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My liver and kidney functions are within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment to end of treatment up to 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to end of treatment up to 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of venetoclax in combination with inotuzumab ozogamicin
Secondary outcome measures
Disease-free survival (DFS)
Event-free survival (EFS)
Measurable residual disease (MRD)-response
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Venetoclax + Inotuzumab Ozogamicin with DexamethasoneExperimental Treatment3 Interventions
Phased 28 day treatment cycles with lead in:
Lead In Cycle: Dose escalated venetoclax 1x daily for days 1-3 with and Dexamethasone daily for days 1-3 lead in, 7 days total.
Induction Cycle 1: Dose escalated venetoclax 1x daily for days 1-21, Dexamethasone daily for days 1-4, Inotuzumab ozogamicin on days 1, 8, and 15
Induction Cycle 2: Dose escalated venetoclax 1x daily for days and Inotuzumab ozogamicin on days 1, 8, and 15
Consolidation Cycles: Up to 5 cycles of dose escalated Venetoclax 1x daily for days and Inotuzumab ozogamicin on days 1, 8, and 15
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Inotuzumab ozogamicin
FDA approved
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,904 Total Patients Enrolled
AbbVieIndustry Sponsor
972 Previous Clinical Trials
506,099 Total Patients Enrolled
Marlise R Luskin, MD, MSCEPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may not be able to do active work.I haven't taken strong CYP3A4 inhibitors or inducers in the last week.I have had hepatitis C but my current viral load is undetectable.I am 18 years old or older.I have had HSCT or CAR-T therapy and meet specific criteria.My liver and kidney functions are within the required range.I cannot take venetoclax by mouth due to absorption issues.I have a history of severe liver disease.I have been treated with inotuzumab ozogamicin before.I have symptoms from brain or spinal cord involvement.I haven't had chemotherapy for ALL within 2 weeks before starting the study drugs, except for certain allowed medications.I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.I do not have any severe ongoing health or mental health conditions.I can understand and sign the consent form.My cancer has returned or didn't respond after at least one chemotherapy treatment.I have recovered from side effects of previous cancer treatments, except for hair loss.My leukemia is confirmed to be CD22 positive.I have chronic hepatitis B but my viral load is undetectable.I have been treated with venetoclax for a relapse before.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax + Inotuzumab Ozogamicin with Dexamethasone
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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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