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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

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 60 Other Conditions

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 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

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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

0 / 16Eligibility criteria met