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

Study Overview
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Brief Summary
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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
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Contact: B1761026@iconplc.com

Official Title
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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

Conditions
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CD33 Positive Acute Myelogenous Leukemia

Intervention / Treatment
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* Biological: Antibody Drug Conjugate Chemotherapeutic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Antibody Drug Conjugate Chemotherapeutic|Three Treatment Regimens: Mylotarg <=9 mg/m2 as a single agent on Day 1 & 14 of a 28-day cycle for a total of two cycles Mylotarg in combination with a recognized anthracycline and/or nucleoside-antagonist containing regimen Mylotarg as monotherapy or in tested combinations with ATRA and/or arsenic trioxide for APL|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsed CD33 AML, Refractory CD33 AML, Relapsed CD33 APL, Refractory CD33 APL, Relapsed CD33 MDS, Refractory CD33 MDS