Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML

Stopped early · Phase 1

Conditions studied: Acute Myeloid Leukemia, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndrome

In brief

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 will attempt to determine the maximum tolerated dose of the immune therapy (gemtuzumab) when given in combination with the myeloablative (high dose) drugs used in this study for allogeneic stem cell transplant. (Part A)

Key facts

Study ID

NCT00669890

Run by

New York Medical College

People needed

12

Starts

2004-05-01

Expected to finish

2013-12-01

Last updated by the study team

2015-04-22

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Morgan Stanley Children's Hospital of NYP — New York, New York, United States

Full record on ClinicalTrials.gov

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