Status:
NO_LONGER_AVAILABLE
Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
Lead Sponsor:
Pfizer
Conditions:
CD33 Positive Acute Myelogenous Leukemia
Eligibility:
All Genders
3+ years
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02312037
Last Update
August 20 2019
Active Locations (142)
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1
University of Alabama at Birmingham/Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States, 99508-2980
3
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
4
Providence Cancer Center
Anchorage, Alaska, United States, 99508