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Monoclonal Antibodies

Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Mary-Elizabeth Percival

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

For adults (>= 18 years of age): Serum creatinine =< 2.0 mg/dL.

For children (< 18 years of age): Glomerular filtration rate (GFR) in ml/min (age 2: 63-175; age 3-12: 89-165; females 13 and older: 75-115; males 13 and older: 85-125).

Must not have

Subjects who have had chemotherapy or radiation therapy within 14 days prior to entering the study.

Uncontrolled or concurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well gemtuzumab ozogamicin works in treating measurable residual disease in patients with acute myeloid leukemia.

Who is the study for?

This trial is for people aged 2 and older with Acute Myeloid Leukemia (AML) who have already had at least one round of standard chemo. They must show minimal remaining disease, be in good enough health to perform daily activities, and not have certain types of AML like APL. Pregnant women can't join, and those able to conceive must test negative for pregnancy.

What is being tested?

The trial tests fractionated Gemtuzumab Ozogamicin (GO), a targeted antibody-chemo combo that seeks out cancer cells by attaching to CD33 receptors on their surface. It's given to patients whose AML isn't fully gone after treatment but is low ('measurable residual disease').

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, liver problems indicated by yellowing skin or eyes, changes in blood counts leading to increased infection risk or bleeding issues, tiredness, nausea, and potential harm to unborn babies.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is good, with a creatinine level of 2.0 mg/dL or less.

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My child's kidney function falls within the required range for their age.

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I was diagnosed with AML, but not APL or biphenotypic AML.

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I can take care of myself but may not be able to do any physical work.

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My AML cancer cells test positive for CD33.

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My leukemia shows minimal signs and is in complete response or near complete response.

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I am at least 2 years old.

Exclusion Criteria

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

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I have not had chemotherapy or radiation in the last 14 days.

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I do not have any severe illnesses that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Clinical response rate

Secondary study objectives

Rate of allogeneic hematopoietic cell transplantation (HCT)

Rate of sinusoidal obstructive syndrome (SOS)

Side effects data

From 2021 Phase 4 trial • 51 Patients • NCT03727750

22%

Febrile Neutropenia

18%

Thrombocytopenia

18%

Hypokalaemia

16%

Nausea

14%

Sepsis

12%

Vomiting

12%

Pyrexia

10%

Anaemia

10%

Neutropenia

10%

Diarrhoea

10%

Aspartate Aminotransferase Increased

10%

Hypomagnesaemia

10%

Headache

10%

Epistaxis

10%

Disease Progression

10%

Constipation

Fatigue

Alanine Aminotransferase Increased

Abdominal Pain Upper

Gingival Bleeding

Asthenia

Chills

Infusion Related Reaction

Gamma-Glutamyltransferase Increased

Acute Kidney Injury

Pneumonia

Atypical Pneumonia

Traumatic Intracranial Haemorrhage

Dehydration

Acute Myeloid Leukaemia

Respiratory Failure

Capillary Leak Syndrome

Atrial Fibrillation

Supraventricular Tachycardia

Vitreous Floaters

Gastric Haemorrhage

Multiple Organ Dysfunction Syndrome

Covid-19 Pneumonia

Escherichia Urinary Tract Infection

Eye Infection Fungal

Neutropenic Sepsis

Pneumonia Klebsiella

Pneumonia Respiratory Syncytial Viral

Sinusitis

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Gemtuzumab Ozogamicin (GO)

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: Treatment (gemtuzumab ozogamicin)Experimental Treatment2 Interventions

Patients receive gemtuzumab ozogamicin IV on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Responders and non-responders, without significant adverse events during the first course, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemtuzumab Ozogamicin

2006

Completed Phase 4

~460

0 / 9Eligibility criteria met