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: -

Clinical Trials

Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

Phase 3

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Gemtuzumab Ozogamicin

First Posted Date: 2019-11-19

Last Posted Date: 2024-11-08

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 414

Registration Number: NCT04168502

Locations: 🇮🇹
ASL Le/1 P.O. Vito Fazzi - UO Ematologia, Lecce, Italy
🇮🇹
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia, Rimini, Italy
🇮🇹
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica, Udine, Italy

and more 45 locations

Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Gemtuzumab Ozogamicin
Drug: Venetoclax

First Posted Date: 2019-08-28

Last Posted Date: 2023-12-13

Lead Sponsor: John Quigley

Target Recruit Count: 18

Registration Number: NCT04070768

Locations: 🇺🇸
University of Michigan Health System, Ann Arbor, Michigan, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

and more 1 locations

CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Gemtuzumab Ozogamicin
Drug: Liposome-encapsulated Daunorubicin-Cytarabine

First Posted Date: 2019-04-05

Last Posted Date: 2023-11-18

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 13

Registration Number: NCT03904251

Locations: 🇺🇸
University of California San Diego, San Diego, California, United States
🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 2 locations

Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Gemtuzumab Ozogamicin
Drug: Midostaurin

First Posted Date: 2019-04-03

Last Posted Date: 2024-12-20

Lead Sponsor: Uma Borate

Target Recruit Count: 18

Registration Number: NCT03900949

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

CPX-351+GO in Subjects 55 Years Old, or Older, With AML

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: CPX-351
Drug: Gemtuzumab Ozogamicin

First Posted Date: 2019-03-18

Last Posted Date: 2023-03-10

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 11

Registration Number: NCT03878927

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia

Phase 2

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Gemtuzumab Ozogamicin
Other: Quality-of-Life Assessment

First Posted Date: 2018-11-13

Last Posted Date: 2024-07-01

Lead Sponsor: University of Washington

Target Recruit Count: 36

Registration Number: NCT03737955

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML

Phase 4

Completed

Conditions: Pharmacokinetics
Safety
ECG

Interventions: Drug: Gemtuzumab Ozogamicin

First Posted Date: 2018-11-01

Last Posted Date: 2022-03-25

Lead Sponsor: Pfizer

Target Recruit Count: 51

Registration Number: NCT03727750

Locations: 🇭🇺
Semmelweis Egyetem I.sz Belgyogyaszati Klinika, Hematologiai Osztaly, Budapest, Hungary
🇬🇧
The Royal Bournemouth and Christchurch NHS Foundation Trust, Bournemouth, Dorset, United Kingdom
🇺🇸
Brody School of Medicine at East Carolina University, Greenville, North Carolina, United States

and more 21 locations

Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome

Phase 2

Recruiting

Conditions: Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
High Risk Myelodysplastic Syndrome
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Recurrent Acute Myeloid Leukemia

Interventions: Drug: Gemtuzumab Ozogamicin
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Other: Quality-of-Life Assessment

First Posted Date: 2018-09-14

Last Posted Date: 2024-11-20

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 50

Registration Number: NCT03672539

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers

Phase 2

Recruiting

Conditions: Acute Myeloid Leukemia
Blasts 10 Percent or More of Bone Marrow Nucleated Cells
Myeloproliferative Neoplasm
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
High Risk Myelodysplastic Syndrome
Myeloid Sarcoma
Philadelphia Chromosome Positive

Interventions: Drug: Cladribine
Drug: Cytarabine
Drug: Dexrazoxane Hydrochloride
Drug: Gemtuzumab Ozogamicin
Drug: Idarubicin

First Posted Date: 2018-07-18

Last Posted Date: 2024-12-17

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 100

Registration Number: NCT03589729

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Atovaquone (Mepron®) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML)

Early Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Atovaquone
Drug: Cytarabine
Drug: Daunorubicin
Drug: Etoposide
Drug: Gemtuzumab Ozogamicin

First Posted Date: 2018-06-26

Last Posted Date: 2024-11-21

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 26

Registration Number: NCT03568994

Locations: 🇺🇸
Baylor College of Medicine - Texas Childrens Hospital, Houston, Texas, United States
🇺🇸
Johns Hopkins Medicine, Baltimore, Maryland, United States

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