Summary

for people ages 3 months and up (full criteria)
at San Diego, California and other locations
study started

Description

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

Official Title

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

Details

Contact:

B1761026@iconplc.com

Keywords

CD33 Positive Acute Myelogenous Leukemia Relapsed CD33 AML Refractory CD33 AML Relapsed CD33 APL Refractory CD33 APL Relapsed CD33 MDS Refractory CD33 MDS Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Antibodies Gemtuzumab Antibody Drug Conjugate Chemotherapeutic

Eligibility

You can join if…

Open to people ages 3 months and up

  • 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

You CAN'T join 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.

Locations

  • UCSD/ Rady Children's Hospital
    San Diego California 92123 United States
  • Children's Hospital of Orange County
    Orange California 92868 United States
  • Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
    Los Angeles California 90027 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02312037
Study Type
Expanded Access
Last Updated
January 29, 2018