Gemtuzumab ozogamicin

Generic Name
Gemtuzumab ozogamicin
Brand Names
Mylotarg
Drug Type
Biotech
Chemical Formula
-
CAS Number
220578-59-6
Unique Ingredient Identifier
8GZG754X6M
Background

Gemtuzumab ozogamicin is a recombinant humanized IgG4 kappa antibody which is conjugated with calicheamicin derivative, a cytotoxic antitumor antibiotic isolated from fermentation of Micromonospora echinospora ssp. calichensis. Gemtuzumab ozogamicin has approximately 50% of the antibody loaded with 4-6 moles calicheamicin per mole of antibody . The antibody ...

Indication

Indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. Indicated for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial tr...

Associated Conditions
Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia (AML), Relapsed Acute Myelogenous Leukemia (AML)
Associated Therapies
-

Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

First Posted Date
2005-07-21
Last Posted Date
2016-09-20
Lead Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Target Recruit Count
600
Registration Number
NCT00121303
Locations
🇬🇧

University Hospital of Wales, Cardiff, Wales, United Kingdom

🇬🇧

Medway Maritime Hospital, Gillingham Kent, England, United Kingdom

🇬🇧

North Hampshire Hospital, Basingstoke, England, United Kingdom

and more 3 locations

CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse

Phase 2
Completed
Conditions
First Posted Date
2004-09-13
Last Posted Date
2012-08-22
Lead Sponsor
Pfizer
Target Recruit Count
55
Registration Number
NCT00003673
Locations
🇺🇸

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

🇺🇸

University of Chicago Cancer Research Center, Chicago, Illinois, United States

🇺🇸

New England Medical Center Hospital, Boston, Massachusetts, United States

and more 7 locations

Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Phase 2
Conditions
First Posted Date
2004-09-09
Last Posted Date
2012-07-24
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
279
Registration Number
NCT00091234
Locations
🇮🇹

Ospedale Binaghi, Cagliari, Italy

🇮🇹

Ospedale Oncologico A. Businco, Cagliari, Italy

🇮🇹

Ospedale Di Montefiascone, Montefiascone, Italy

and more 42 locations

CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse

Phase 2
Completed
Conditions
First Posted Date
2004-08-24
Last Posted Date
2012-08-22
Lead Sponsor
Pfizer
Target Recruit Count
55
Registration Number
NCT00003131
Locations
🇺🇸

Sylvester Cancer Center, University of Miami, Miami, Florida, United States

🇺🇸

Beckman Research Institute, City of Hope, Duarte, California, United States

🇺🇸

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States

and more 10 locations

Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia

Phase 2
Completed
Conditions
First Posted Date
2004-08-05
Last Posted Date
2011-11-30
Lead Sponsor
Fred Hutchinson Cancer Center
Registration Number
NCT00089050
Locations
🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

First Posted Date
2004-06-16
Last Posted Date
2015-09-30
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
637
Registration Number
NCT00085709
Locations
🇺🇸

Perry Memorial Hospital, Princeton, Illinois, United States

🇺🇸

Cancer Center of Kansas-Independence, Independence, Kansas, United States

🇺🇸

Munson Medical Center, Traverse City, Michigan, United States

and more 274 locations

Gemtuzumab Ozogamicin, Fludarabine, and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 2
Completed
Conditions
First Posted Date
2004-03-25
Last Posted Date
2010-04-02
Lead Sponsor
Fred Hutchinson Cancer Center
Registration Number
NCT00008151
Locations
🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

Phase 2
Completed
Conditions
First Posted Date
2004-02-16
Last Posted Date
2012-07-16
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
106
Registration Number
NCT00006122
Locations
🇫🇷

Hotel Dieu de Paris, Paris, France

🇧🇪

A.Z. St. Jan, Brugge, Belgium

🇦🇹

Innsbruck Universitaetsklinik, Innsbruck, Austria

and more 15 locations

Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome

Phase 2
Completed
Conditions
First Posted Date
2004-02-11
Last Posted Date
2012-07-16
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
31
Registration Number
NCT00077116
Locations
🇨🇭

Universitaetsspital-Basel, Basel, Switzerland

🇧🇪

AZ Sint-Jan, Brugge, Belgium

🇧🇪

H. Hartziekenhuis - Roeselaere., Roeselare, Belgium

and more 6 locations

Gemtuzumab in Treating Patients With Myelodysplastic Syndrome

Phase 2
Conditions
First Posted Date
2004-01-14
Last Posted Date
2013-12-19
Lead Sponsor
Jonsson Comprehensive Cancer Center
Registration Number
NCT00022321
Locations
🇺🇸

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

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