Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
- Conditions
- CD33 Positive Acute Myelogenous Leukemia
- Registration Number
- NCT02312037
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
Contact:
B1761026@iconplc.com
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
-
Age >=3 months
-
Adequate non-hematologic organ function
-
- 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.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (135)
University of Alabama at Birmingham/Children's of Alabama
🇺🇸Birmingham, Alabama, United States
Alaska Oncology & Hematology, LLC
🇺🇸Anchorage, Alaska, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
Banner Pediatric Specialists Hematology/Oncology Clinic
🇺🇸Mesa, Arizona, United States
Cardon Children's Medical Center.
🇺🇸Mesa, Arizona, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
🇺🇸Los Angeles, California, United States
Kaiser Permanente - Oakland Medical Center
🇺🇸Oakland, California, United States
Kaiser Permanente - Oakland
🇺🇸Oakland, California, United States
Scroll for more (125 remaining)University of Alabama at Birmingham/Children's of Alabama🇺🇸Birmingham, Alabama, United States