← Back to Search

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

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

Response rate

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

Fatigue

Alanine Aminotransferase Increased

Asthenia

Abdominal Pain Upper

Gamma-Glutamyltransferase Increased

Infusion Related Reaction

Gingival Bleeding

Chills

Pneumonia

Acute Kidney Injury

Atypical Pneumonia

Dehydration

Traumatic Intracranial Haemorrhage

Atrial Fibrillation

Covid-19 Pneumonia

Escherichia Urinary Tract Infection

Fall

Capillary Leak Syndrome

Supraventricular Tachycardia

Eye Infection Fungal

Neutropenic Sepsis

Pneumonia Respiratory Syncytial Viral

Sinusitis

Acute Myeloid Leukaemia

Respiratory Failure

Vitreous Floaters

Gastric Haemorrhage

Multiple Organ Dysfunction Syndrome

Pneumonia Klebsiella

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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

Gemtuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02221310 — Phase 2

Myelodysplastic Syndrome Research Study Groups: Gemtuzumab Ozogamicin

Myelodysplastic Syndrome Clinical Trial 2023: Gemtuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT02221310 — Phase 2

Gemtuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02221310 — Phase 2

Frequently Asked Questions

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

Could you tell me about other research projects that have used Gemtuzumab Ozogamicin?

"At this moment in time, there are 27 clinical trials researching Gemtuzumab Ozogamicin with 3 trials being in Phase 3. Some of the studies for Gemtuzumab Ozogamicin are running out of locations in Baltimore, Maryland; however, 572 research centres are still conducting these tests."

Answered by AI

Are there any unfilled vacancies in this research project?

"According to the clinicaltrials.gov website, this study is not currently looking for new candidates. Although it was last edited on 9/26/2022, the trial was first posted on 11/1/2011. There are 1,740 other trials actively recruiting patients right now."

Answered by AI

What is the Gemtuzumab Ozogamicin FDA approval status?

"Gemtuzumab Ozogamicin has only undergone Phase 2 trials, so there is some safety data but no efficacy data. We rated it a 2."

Answered by AI

How many participants are included in this research project?

"At this time, this clinical trial is not seeking new patients. This study was originally posted on November 1st, 2011 and was most recently edited on September 26th, 2022. However, there are 27 other studies actively recruiting participants with leukemia that may be of interest."

Answered by AI

Recent research and studies

Biology of Blood and Marrow TransplantationJournal

A Phase I Study of Gemtuzumab Ozogamicin (GO) in Combination with Busulfan and Cyclophosphamide (bu/cy) and Allogeneic Stem Cell Transplantation in Children with Poor-risk CD33+ AML: A New Targeted Immunochemotherapy Myeloablative Conditioning (MAC) Regimen

Satwani, Prakash, Monica Bhatia, James H. Garvin Jr., Diane George, Filemon Dela Cruz, John Le Gall, Zhezhen Jin, et al.. 2012. “A Phase I Study of Gemtuzumab Ozogamicin (GO) in Combination with Busulfan and Cyclophosphamide (bu/cy) and Allogeneic Stem Cell Transplantation in Children with Poor-risk CD33+ AML: A New Targeted Immunochemotherapy Myeloablative Conditioning (MAC) Regimen”. Biology of Blood and Marrow Transplantation. Elsevier BV. doi:10.1016/j.bbmt.2011.11.007.

clinicaltrials.govStudy

Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS

Mitchell Cairo 2011. "Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02221310.