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
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
Contact:
Inclusion Criteria:
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:
Los Angeles, California 90027, United States
New Haven, Connecticut 06510, United States
St. Petersburg, Florida 33701, United States
Chicago, Illinois 60637, United States
Maywood, Illinois 60153, United States
Maywood, Illinois 60153, United States
Indianapolis, Indiana 46237, United States
St Louis, Missouri 63110, United States
New York, New York 10021, United States
New York, New York 10065, United States
Cleveland, Ohio 44106, United States
Philadelphia, Pennsylvania 19107-4215, United States
Philadelphia, Pennsylvania 19107, United States
Philadelphia, Pennsylvania 19107, United States
Philadelphia, Pennsylvania 19107, United States
Pittsburgh, Pennsylvania 15224, United States
Nashville, Tennessee 37203, United States
Nashville, Tennessee 37232, United States
Houston, Texas 77030, United States
Charlottesville, Virginia 22903, United States