← Back to Search

Monoclonal Antibodies

Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Mitchell S. Cairo, M.D.
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 way to treat AML and MDS using stem cells from a donor followed by targeted therapy.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
to determine toxicity
to evaluate incidence of graft failure
to evaluate survival rates
Secondary outcome measures
Chimerism
Graft-versus-host disease
Minor histocompatibility antigen

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%
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
Consolidation therapy with GO will be administered between days 60 and 180 post transplantation when the ANC is >1000/mm3 and platelet count is >40,000/mm3 untransfused x 3 days after AlloSCT and again at minimum 8 weeks later.
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
6,035 Total Patients Enrolled
Mitchell S. Cairo, M.D.Principal InvestigatorNew York Medical College

Media Library

Gemtuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02117297 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Gemtuzumab Ozogamicin
Acute Myeloid Leukemia Clinical Trial 2023: Gemtuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT02117297 — Phase 2
Gemtuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02117297 — Phase 2

Frequently Asked Questions

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

How many volunteers are involved in this research initiative?

"Unfortunately, this medical trial is not presently recruiting for participants. Initially published on November 1st 2011 and last updated September 26th 2022, it has since become inactive. Those searching for clinical trials related to preleukemia can find 1651 active studies while those looking into Gemtuzumab Ozogamicin have 26 alternatives available."

Answered by AI

Has Gemtuzumab Ozogamicin received regulatory approval from the US Food and Drug Administration?

"After careful consideration, we evaluated Gemtuzumab Ozogamicin's safety to be a 2. Phase 2 trials have supplied evidence of the drug's security but there is yet no proof that it has effective therapeutic properties."

Answered by AI

Is recruitment still underway for this clinical experiment?

"At this moment, no patients are being recruited for the trial posted on November 1st 2011. However, if you seek out alternative studies 1651 trials recruiting participants with preleukemia and 26 examinations employing Gemtuzumab Ozogamicin have opened their doors to volunteers."

Answered by AI

Have there been any previous experiments conducted with Gemtuzumab Ozogamicin?

"As of now, there are 26 trials researching Gemtuzumab Ozogamicin with 3 in their concluding phase. Of these 26 studies, the majority are located around Baltimore, Maryland; however, patients can find centres conducting clinical research on this drug at 582 different locations worldwide."

Answered by AI
~2 spots leftby Apr 2025