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Monoclonal Antibodies

Venetoclax + Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Sean Quigley, MD

Research Sponsored by John Quigley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 to 75 years at the time of consent.

CD33 expression (by flow or IHC) in at least 20% of the leukemia blasts per local pathologist.

Must not have

Malabsorption syndrome or other condition that precludes enteral route of administration.

Unresolved ≥grade 2 clinically significant nonhematologic toxicities from prior anticancer therapy or unresolved disseminated intravascular coagulation ≥ grade 2 per CTCAE v5 criteria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy to treat people with a certain type of leukemia that has relapsed or is resistant to treatment. The goal is to find the best dose of the new combination therapy that doesn't cause severe side effects. The trial will also measure how well the new combination therapy works.

Who is the study for?

Adults aged 18-75 with relapsed or refractory acute myeloid leukemia (AML) that expresses CD33 on at least 20% of blasts. They must have an ECOG Performance Status of 0-2, not be pregnant, and agree to use contraception. Exclusions include a history of certain blood disorders, uncontrolled infections, recent other cancer treatments, HIV positivity, CNS AML involvement, prior stem cell transplant within two months or previous treatment with the study drugs unless specific conditions are met.

What is being tested?

The trial is testing the combination of Venetoclax and Gemtuzumab Ozogamicin (GO) to find the highest dose patients can take without severe side effects in those with AML. Participants will receive one cycle of therapy followed by consolidation if they respond well. Responders continue maintenance therapy until disease progression or unacceptable toxicity occurs.

What are the potential side effects?

Potential side effects include severe neutropenia (low white blood cell count), thrombocytopenia (low platelet count), organ inflammation, infusion reactions from GO/Venetoclax administration and non-hematologic toxicities like infections during the first treatment cycle.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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My leukemia cells show CD33 expression in at least 20% of blasts.

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I finished my last cancer treatment over 21 days ago and have recovered from its side effects.

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I can care for myself and am up and about more than 50% of my waking hours.

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My recent tests show my organs are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take medications by mouth due to a digestive condition.

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I don't have ongoing major side effects from cancer treatment.

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I have been diagnosed with acute promyelocytic leukemia.

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My white blood cell count is high and I need treatment to lower it.

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I cannot or do not want to have a bone marrow test.

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I have undergone more than three different treatment plans for my condition.

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I have a history of serious heart issues, including CHF or angina.

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I have had a condition where small veins in my liver were blocked.

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My leukemia has spread to my brain or spinal cord.

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I had a stem cell transplant less than 2 months ago.

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I have a history of blood disorders like myelofibrosis or leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 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 (MTD) of Venetoclax when administered with GO

Secondary study objectives

Event-free Survival

Overall response rate

Rate of Anti-leukemic activity

+2 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

SARS-CoV-2 test positive

11%

Sepsis

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Awards & Highlights

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: Gemtuzumab Ozogamicin(GO) + VenetoclaxExperimental Treatment2 Interventions

Gemtuzumab Ozogamicin(GO) + Venetoclax

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2240

Gemtuzumab Ozogamicin

2006

Completed Phase 4

~460

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

John QuigleyLead Sponsor

PfizerIndustry Sponsor

4,670 Previous Clinical Trials

17,826,912 Total Patients Enrolled

AbbVieIndustry Sponsor

1,037 Previous Clinical Trials

523,075 Total Patients Enrolled

Sean Quigley, MDPrincipal InvestigatorUniversity of Illinois at Chicago

John Quigley, MD2.84 ReviewsPrincipal Investigator - University of Illinois at Chicago

Big Ten Cancer Research Consortium

2 Previous Clinical Trials

52 Total Patients Enrolled

1Patient Review

His apathetic attitude and lack of concern for my well-being led me to believe that he is only interested in prescribing medication without any regard for my long-term health.