Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Conditions
Keywords
targeted therapy, leukemia, MDS, immune therapy
Brief summary
Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy followed by allogeneic stem cell transplantation will be given to patients with high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).
Detailed description
Gemtuzumab ozogamicin in combination with busulfan and cyclophosphamide (immunochemotherapy) conditioning followed by allogeneic stem cell transplantation + anti-thymocyte globulin (unrelated donors only) in patients with high risk CD33+AML or MDS meeting eligibility criteria.
Interventions
DRUGGemtuzumab Ozogamicin
Gemtuzumab Ozogamicin 7.5 mg/m\^2/dose given IV over 2 hours once during conditioning
Sponsors
New York Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 25 Years
Healthy volunteers
No
Inclusion criteria
* Disease Status: * History of AML Induction/Reinduction Failure * AML 1st Complete Remission (CR) with poor cytogenetics * AML 2nd CR with minimal residual disease (MRD) * AML 3rd CR * AML in refractory relapse but ≤25% bone marrow leukemia blasts * MDS with \>6% bone marrow blasts at diagnosis * Secondary MDS with ≤5% bone marrow myeloblasts at diagnosis Disease Immunophenotype: • Disease must express a minimum of \>/= 10% CD33+ for patients with AML Organ Function: • Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function Age: ≤25 years of age Donor: matched family donor, unrelated cord blood donor, unrelated adult donor
Exclusion criteria
* Patients with active central nervous system (CNS) AML/MDS disease at time of conditioning therapy * Female patients who are pregnant * Karnofsky \<50% or Lansky \<50% if 10 years or less * Age \>25 years * Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 1 year | overall response rate (CR + PR) in patients receiving GO, busulfan and cyclophosphamide and AlloSCT in patients with measurable disease (relapse/refractory) with high risk CD33+ AML/MDS |
Countries
United States
Outcome results
None listed