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

NCT02312037•Pfizer

View on ClinicalTrials.gov

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

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (142)

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

Key Dates

Last Updated

August 20, 2019

Conditions

CD33 Positive Acute Myelogenous Leukemia

Interventions

Antibody Drug Conjugate Chemotherapeutic

BIOLOGICAL