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
-

Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Phase 2
Completed
Conditions
First Posted Date
2003-11-05
Last Posted Date
2023-06-22
Lead Sponsor
Eastern Cooperative Oncology Group
Registration Number
NCT00005962
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

๐Ÿ‡บ๐Ÿ‡ธ

Hahnemann University Hospital, Philadelphia, Pennsylvania, United States

๐Ÿ‡บ๐Ÿ‡ธ

CCOP - Columbus, Columbus, Ohio, United States

and more 62 locations

Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

Phase 2
Completed
Conditions
First Posted Date
2003-10-07
Last Posted Date
2014-02-20
Lead Sponsor
Children's Oncology Group
Target Recruit Count
350
Registration Number
NCT00070174
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

St. Barnabas Medical Center, Livingston, New Jersey, United States

๐Ÿ‡บ๐Ÿ‡ธ

All Children's Hospital, St. Petersburg, Florida, United States

and more 145 locations

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

First Posted Date
2003-01-27
Last Posted Date
2012-08-27
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
472
Registration Number
NCT00052299
Locations
๐Ÿ‡ฎ๐Ÿ‡น

Ospedale San Bortolo, Vicenza, Italy

๐Ÿ‡ณ๐Ÿ‡ฑ

Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands

๐Ÿ‡ฆ๐Ÿ‡น

A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung, Linz, Austria

and more 52 locations

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

Phase 2
Completed
Conditions
First Posted Date
2003-01-27
Last Posted Date
2014-01-06
Lead Sponsor
Genta Incorporated
Registration Number
NCT00017589
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Genta Incorporated, Berkeley Heights, New Jersey, United States

S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

Phase 2
Completed
Conditions
First Posted Date
2003-01-27
Last Posted Date
2015-03-06
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
33
Registration Number
NCT00049179
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Charles B. Eberhart Cancer Center at DeKalb Medical Center, Decatur, Georgia, United States

๐Ÿ‡บ๐Ÿ‡ธ

Kennestone Cancer Center at Wellstar Kennestone Hospital, Marietta, Georgia, United States

๐Ÿ‡บ๐Ÿ‡ธ

David C. Pratt Cancer Center at St. John's Mercy, St. Louis, Missouri, United States

and more 148 locations

Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

Phase 1
Completed
Conditions
First Posted Date
2003-01-27
Last Posted Date
2014-02-20
Lead Sponsor
Children's Oncology Group
Target Recruit Count
47
Registration Number
NCT00028899
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Emory University Hospital - Atlanta, Atlanta, Georgia, United States

๐Ÿ‡บ๐Ÿ‡ธ

CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States

๐Ÿ‡บ๐Ÿ‡ธ

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States

and more 73 locations

Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

Phase 2
Completed
Conditions
First Posted Date
2002-05-20
Last Posted Date
2013-02-13
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Registration Number
NCT00037596

Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia

Phase 2
Completed
Conditions
First Posted Date
2002-05-20
Last Posted Date
2009-08-21
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
69
Registration Number
NCT00037583
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