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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study 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.Check my eligibility
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').See study design
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 belowSelect...
My kidney function is good, with a creatinine level of 2.0 mg/dL or less.
Select...
My child's kidney function falls within the required range for their age.
Select...
I was diagnosed with AML, but not APL or biphenotypic AML.
Select...
I can take care of myself but may not be able to do any physical work.
Select...
My AML cancer cells test positive for CD33.
Select...
My leukemia shows minimal signs and is in complete response or near complete response.
Select...
I am at least 2 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical response rate
Secondary outcome measures
Rate of allogeneic hematopoietic cell transplantation (HCT)
Rate of sinusoidal obstructive syndrome (SOS)
Side effects data
From 2021 Phase 4 trial • 51 Patients • NCT0372775022%
Febrile Neutropenia
18%
Thrombocytopenia
18%
Hypokalaemia
16%
Nausea
14%
Sepsis
12%
Vomiting
12%
Pyrexia
10%
Constipation
10%
Diarrhoea
10%
Anaemia
10%
Neutropenia
10%
Aspartate Aminotransferase Increased
10%
Disease Progression
10%
Hypomagnesaemia
10%
Headache
10%
Epistaxis
8%
Fatigue
8%
Alanine Aminotransferase Increased
6%
Asthenia
6%
Abdominal Pain Upper
6%
Gamma-Glutamyltransferase Increased
6%
Infusion Related Reaction
6%
Gingival Bleeding
6%
Chills
6%
Pneumonia
6%
Acute Kidney Injury
4%
Atypical Pneumonia
2%
Dehydration
2%
Traumatic Intracranial Haemorrhage
2%
Atrial Fibrillation
2%
Covid-19 Pneumonia
2%
Escherichia Urinary Tract Infection
2%
Fall
2%
Capillary Leak Syndrome
2%
Supraventricular Tachycardia
2%
Eye Infection Fungal
2%
Neutropenic Sepsis
2%
Pneumonia Respiratory Syncytial Viral
2%
Sinusitis
2%
Acute Myeloid Leukaemia
2%
Respiratory Failure
2%
Vitreous Floaters
2%
Gastric Haemorrhage
2%
Multiple Organ Dysfunction Syndrome
2%
Pneumonia Klebsiella
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemtuzumab Ozogamicin (GO)
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
~440
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,950 Total Patients Enrolled
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,664 Total Patients Enrolled
Mary-Elizabeth PercivalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
94 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bilirubin levels are within twice the normal range, or I have Gilbert's disease.My child's bilirubin levels are within the normal range for their age, or they have Gilbert's disease.My kidney function is good, with a creatinine level of 2.0 mg/dL or less.I have not had chemotherapy or radiation in the last 14 days.I've had at least one round of initial chemotherapy, or I'm an adult at any treatment stage, or a child with specific cancer markers after certain treatments.My child's kidney function falls within the required range for their age.I was diagnosed with AML, but not APL or biphenotypic AML.I do not have any severe illnesses that would stop me from following the study's requirements.I can take care of myself but may not be able to do any physical work.My liver tests, AST and ALT, are within normal limits for my age.My child's liver tests are within the normal range for their age.My AML cancer cells test positive for CD33.I am of childbearing age and have a negative pregnancy test.My leukemia shows minimal signs and is in complete response or near complete response.I am at least 2 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (gemtuzumab ozogamicin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants being accepted for this trial?
"According to information found on the clinicaltrials.gov website, this trial is actively recruiting patients. It was first published on November 30th 2018 and last updated on September 7th 2022."
Answered by AI
Are there any potential hazards associated with Gemtuzumab Ozogamicin treatment?
"Assessed on a scale from 1 to 3, the safety of gemtuzumab ozogamicin was determined to be 2. This is due to its current standing as a Phase 2 trial and lack of efficacy-affirming data."
Answered by AI
How many participants has this research project enrolled thus far?
"Affirmative. According to the details posted on clinicaltrials.gov, recruitment for this medical trial is currently underway; the study was initially published on November 30th 2018 and most recently updated September 7th 2022. 36 participants from one site are required for successful completion of this research project."
Answered by AI
What other research studies have been conducted with Gemtuzumab Ozogamicin?
"At the moment, 26 trials for Gemtuzumab Ozogamicin are in progress. 3 of these studies have entered Phase 3 and 582 trial sites exist worldwide (with a majority situated in Maryland)."
Answered by AI
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