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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
Females of childbearing potential and males must be willing to use effective contraception during treatment and for at least 30 days after the last dose of Venetoclax. Females will be advised to use effective contraception for at least 6 months after the last dose of Gemtuzumab and males for at least 3 months after the last dose of Gemtuzumab.
Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 willing to use effective birth control during and after my treatment.
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I am not pregnant and can prove it with a test taken in the last week.
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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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My AML has returned or is not responding to treatment, and I've had prior therapy.
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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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I can understand and follow the study's procedures.
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My recent tests show my organs are functioning well.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of Venetoclax when administered with GO
Secondary outcome measures
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%
Anaemia
11%
SARS-CoV-2 test positive
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
Dermatitis
11%
Pneumonia
11%
Blood creatinine increased
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
COVID-19
11%
Supraventricular tachycardia
11%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

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
~1990
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440

Find a Location

Who is running the clinical trial?

John QuigleyLead Sponsor
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,665 Total Patients Enrolled
AbbVieIndustry Sponsor
946 Previous Clinical Trials
496,454 Total Patients Enrolled

Media Library

Gemtuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04070768 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Gemtuzumab Ozogamicin(GO) + Venetoclax
Acute Myeloid Leukemia Clinical Trial 2023: Gemtuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT04070768 — Phase 1
Gemtuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04070768 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other investigations involving the drug Venetoclax?

"Presently, 243 studies involving Venetoclax are active with 31 of them in the third phase. While most research on this medication is based out of Antwerpen and New york, there are a total 7775 locations running these trials across the globe."

Answered by AI

Has the Federal Drug Administration sanctioned Venetoclax for public use?

"Our team at Power has assigned Venetoclax a score of 1 based on its Phase 1 classification, indicating that there is only limited data available to assess both safety and efficacy."

Answered by AI

Are participants still being accepted into this experiment?

"According to clinicaltrials.gov, this experiment is still gathering participants since its original posting on September 6th 2019 and latest update on November 18th 2022."

Answered by AI

How many participants are being recruited for this research?

"This trial requires 24 eligible patients and has two confirmed locations: the Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis, IN and the University of Nebraska Medical Center in Omaha, NE."

Answered by AI

In which locations is the clinical experiment being conducted?

"The 4 sites recruiting participants for this research trial are Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis, University of Nebraska Medical Center in Omaha, Univeristy of Illinois in Chicago, as well as another four different locations."

Answered by AI

What maladies is Venetoclax regularly employed to treat?

"Venetoclax has been demonstrated to effectively treat individuals with a fresh diagnosis of small lymphocytic lymphoma or chronic lymphocytic leukemia (CLL)."

Answered by AI
~3 spots leftby Mar 2025