Status:
TERMINATED
Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML
Lead Sponsor:
New York Medical College
Conditions:
Acute Myeloid Leukemia
Juvenile Myelomonocytic Leukemia
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE1
Brief Summary
The addition of gemtuzumab ozogamicin (GO) in combination with Busulfan/Cyclophosphamide followed by AlloSCT in patients with high risk CD33+ AML/JMML/MDS will be safe and well tolerated. This study ...
Detailed Description
Gemtuzumab Ozogamicin (CMA-676) is a chemotherapeutic agent consisting of recombinant humanized anti-CD33 antibody conjugated with calicheamicin, a highly potent cytotoxic antitumor antibiotic. The an...
Eligibility Criteria
Inclusion
- Eligibility
- Disease Status
- AML Induction Failure
- AML in 1st, 2nd, or 3rd Relapse (\>10% bone marrow blasts)
- AML greater than or equal to 3rd CR
- MDS with \>6% bone marrow blasts at diagnosis
- Secondary MDS with less than or equal to 5% bone marrow myeloblasts at diagnosis
- JMML with \>6% bone marrow myeloblasts at diagnosis
- Disease Immunophenotype Patients (AML only) receiving gemtuzumab ozogamicin must express minimum of \>10% or =10% CD33 positivity. Patients with \<10% CD33 positivity will not receive gemtuzumab ozogamicin.
- Organ Function
- Patients must have adequate organ function as defined below:
- Adequate renal function defined as:
- Serum creatinine \<1.5 x normal, or
- Creatinine clearance or radioisotope GFR 40 ml/min/m2 or \>60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range
- Adequate liver function defined as:
- Total bilirubin 1.5 x normal, or SGOT (AST) or SGPT (ALT) \<2.0 x normal or =2.0 x normal
- Adequate cardiac function defined as:
- Shortening fraction of \>27% by echocardiogram, or
- Ejection fraction of \>47% by radionuclide angiogram or echocardiogram
- Adequate pulmonary function defined as:
- DLCO \>55% or =55% by PFT
- For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air
Exclusion
- Patients with active CNS AML/JMML/MDS disease at time of conditioning therapy
- Female patients who are pregnant (positive HCG)
- Karnofsky \<50% or Lansky \<50% if 10 years or less
- Age \>65 years
- Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00669890
Start Date
May 1 2004
End Date
December 1 2013
Last Update
April 22 2015
Active Locations (1)
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1
Morgan Stanley Children's Hospital of NYP
New York, New York, United States, 10032