Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
Status: | No longer available |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 9/19/2018 |
Gemtuzumab Ozogamicin (Mylotarg (Registered)) Expanded Access Protocol For Treatment Of Patients In The United States With Relapsed/Refractory Acute Myelogenous Leukemia Who May Benefit From Treatment And Have No Access To Other Comparable/Alternative Therapy
An expanded access/compassionate use protocol that allows access to Mylotarg for
relapsed/refractory AML CD33 positive patients in the USA.
Contact: B1761026@iconplc.com
relapsed/refractory AML CD33 positive patients in the USA.
Contact: B1761026@iconplc.com
Contact:
B1761026@iconplc.com
B1761026@iconplc.com
Inclusion Criteria:
- Confirmed diagnosis of relapsed/refractory AML (defined as >=5% marrow blasts by
morphology), including MDS, with persisting rising blasts and no other comparable or
satisfactory alternative therapy available. If bone marrow has <5% blasts by
morphology but the patient has evidence of relapse with extra-medullary disease
progression. In select cases presenting with conversion of MRD from negative to
positive, treatment with GO may be allowed where no alternative treatments are
feasible.
OR
- Confirmed diagnosis of relapsed or refractory APL with persisting or rising leukemic
burden (either by morphology, cytogenetic analysis or by molecular techniques), and no
other comparable or satisfactory alternative therapy available.
- Documentation that malignant cells express CD33
4) Age >=3 months
5) Adequate non-hematologic organ function
Exclusion Criteria:
- Untreated AML and MDS or AML and MDS in complete remission.
- Patients with a known history of VOD/SOS.
- Patients with a known hypersensitivity to Mylotarg or its parts: hP67.6 antibody,
calicheamicin derivatives or other ingredients.
- Participation in other studies involving investigational drug(s) (Phases 1-4) during
study participation.
We found this trial at
139
sites
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4900 Mueller Boulevard
Austin, Texas 78723
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, Illinois 60637
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Los Angeles, California 90027
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1032 West Sheridan Road
Maywood, Illinois 60153
Maywood, Illinois 60153
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2160 S. First Ave.
Maywood, Illinois 60153
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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2300 Patterson Street
Nashville, Tennessee 37203
Nashville, Tennessee 37203
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, Connecticut 06510
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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