Status:
COMPLETED
Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS
Lead Sponsor:
New York Medical College
Conditions:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE2
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 myelogeno...
Detailed Description
Gemtuzumab ozogamicin in combination with busulfan and cyclophosphamide (immunochemotherapy) conditioning followed by allogeneic stem cell transplantation + anti-thymocyte globulin (unrelated donors o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 4 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02221310
Start Date
December 7 2011
End Date
April 4 2023
Last Update
October 26 2023
Active Locations (1)
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1
New York Medical College
Valhalla, New York, United States, 10595