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

Pfizer

Status

Conditions: CD33 Positive Acute Myelogenous Leukemia

Treatments: Biological: Antibody Drug Conjugate Chemotherapeutic

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02312037

B1761026

Details and patient eligibility

About

An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA.

Contact: [e-mail]

Full description

Contact:

[e-mail]

Sex: All

Ages: 3+ months old

Volunteers: No 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.