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

Contact:

B1761026@iconplc.com

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.