Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
NCT02312037 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2019-08-20
Summary
An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA.
Contact: [email protected]
Conditions
- CD33 Positive Acute Myelogenous Leukemia
Interventions
- BIOLOGICAL
-
Antibody Drug Conjugate Chemotherapeutic
Three Treatment Regimens: 1. Mylotarg \<=9 mg/m2 as a single agent on Day 1 \& 14 of a 28-day cycle for a total of two cycles 2. Mylotarg in combination with a recognized anthracycline and/or nucleoside-antagonist containing regimen 3. Mylotarg as monotherapy or in tested combinations with ATRA and/or arsenic trioxide for APL
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Eligibility
- Min Age
- 3 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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