Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy

NO_LONGER_AVAILABLE

Conditions studied: CD33 Positive Acute Myelogenous Leukemia

In brief

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

Key facts

Study ID

NCT02312037

Run by

Pfizer

Last updated by the study team

2019-08-20

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Children's Hospital of Orange County — Orange, California, United States
• Kaiser Permanente - Roseville — Roseville, California, United States
• UCSD/ Rady Children's Hospital — San Diego, California, United States
• Kaiser Permanente - Santa Clara — Santa Clara, California, United States
• c/o Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Yale New-Haven Hospital & Smilow Cancer Center — New Haven, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Yale Medical Group — Trumbull, Connecticut, United States
• Nemours - A.I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• JDCH pediatric Oncology and Hematology — Hollywood, Florida, United States
• Joe Dimaggio Children's Hospital — Hollywood, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• University of Alabama at Birmingham/Children's of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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