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Monoclonal Antibodies
Gemtuzumab Ozogamicin for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Led By Mitchell S Cairo, MD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test a new cancer treatment for people with high risk AML or MDS. The treatment consists of targeted immune therapy with gemtuzumab ozogamicin, chemotherapy, and allogeneic stem cell transplantation.
Eligible Conditions
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
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: Gemtuzumab OzogamicinExperimental Treatment1 Intervention
Conditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.
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?
New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
6,036 Total Patients Enrolled
Mitchell S Cairo, MDPrincipal InvestigatorNew York Medical College
14 Previous Clinical Trials
1,143 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lungs work well enough for you to participate in the study.Your heart is in good working condition.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
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