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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
Must not have
Participants with malabsorption syndrome or conditions precluding enteral route of venetoclax administration
Participants with history of decompensated hepatic cirrhosis, VOD/SOS, or severe liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to end of treatment up to 9 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a combination of drugs including venetoclax, inotuzumab ozogamicin, and dexamethasone in patients with a specific type of leukemia that hasn't responded to standard treatments. Venetoclax helps kill cancer cells by blocking proteins they need to survive, while inotuzumab ozogamicin targets and kills cancer cells by delivering chemotherapy directly inside them.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take venetoclax by mouth due to absorption issues.
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I have a history of severe liver disease.
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I have been treated with inotuzumab ozogamicin before.
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I have symptoms from brain or spinal cord involvement.
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I haven't had chemotherapy for ALL within 2 weeks before starting the study drugs, except for certain allowed medications.
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I do not have any severe ongoing health or mental health conditions.
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I have been treated with venetoclax for a relapse before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to end of treatment up to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to end of treatment up to 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose of venetoclax in combination with inotuzumab ozogamicin
Secondary study objectives
Disease-free survival (DFS)
Event-free survival (EFS)
Measurable residual disease (MRD)-response
+2 more

Awards & Highlights

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.

Trial 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
Venetoclax
FDA approved
Dexamethasone
FDA approved
Inotuzumab ozogamicin
FDA approved

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,103 Previous Clinical Trials
359,372 Total Patients Enrolled
AbbVieIndustry Sponsor
1,015 Previous Clinical Trials
519,155 Total Patients Enrolled
Marlise R Luskin, MD, MSCEPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Inotuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05016947 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Venetoclax + Inotuzumab Ozogamicin with Dexamethasone
Acute Lymphoblastic Leukemia Clinical Trial 2023: Inotuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT05016947 — Phase 1
Inotuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05016947 — Phase 1
~1 spots leftby Dec 2024