Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia

Completed · Phase 1

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

In brief

Allogeneic stem cell transplantation (AlloSCT) followed by targeted immune therapy Gemtuzumab Ozogamicin patients with acute myeloid leukemia (AML)/juvenile myelomonocytic leukemia (JMML)/myelodysplastic syndromes (MDS) will be safe and well tolerated.

Key facts

Study ID

NCT01020539

Run by

Columbia University

People needed

18

Starts

2002-09-11

Expected to finish

2020-12-01

Last updated by the study team

2021-08-06

Who can join

Age: 0 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disease Status
• AML 1st complete remission (CR) with a matched family donor (excluding Downs Syndrome, acute promyelocytic leukaemia (APL), poor cytogenetics (12p, 5q, -7 and FMS-like tyrosine kinase 3 (FLT3) mutations or duplication t(9;11) and others)) and patients consented to and registered on an upfront AML COG study with a matched family donor)
• AML 1st CR (excluding Downs Syndrome, APL, and chromosome translocation (8;21) or inversion (16) or poor cytogenetics (12p, 5q, -7, FLT3 mutation or duplication t(9;11) and others)) with unrelated donor
• AML 2nd CR
• Myelodysplastic Syndrome (MDS) and ≤ 5% bone marrow myeloblasts at diagnosis (de novo patients only)
• Juvenile Myelomonocytic Leukemia (JMML) and ≤ 5% bone marrow myeloblasts at diagnosis
• In regards to disease immunophenotype, disease must express a minimum of ≥10% Cell Differential 33 (CD33) positivity for patients with AML
• 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 glomerular filtration rate (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 2.0 x upper limit of normal (ULN), or serum glutamic-oxaloacetic transaminase (SGOT)(aspartate aminotransferase (AST)) or serum glutamic-pyruvic transaminase (SGPT)(alanine aminotransferase (ALT)) < 5.0 x ULN
• Adequate cardiac function defined as:
• Shortening fraction of ≥ 25% by echocardiogram, or
• Ejection fraction of ≥ 45% by radionuclide angiogram or echocardiogram
• Adequate pulmonary function defined as:
• Diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 40% by pulmonary function tests (PFT) (Uncorrected)
• 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 central nervous system (CNS) AML/JMML disease at time of preparative regimen
• Secondary MDS
• Poor cytogenetics (12p, 5q, -7, FLT3 mutation or duplication)
• Female patients who are pregnant (positive human chorionic gonadotropin(hCG))
• Karnofsky <70% or Lansky <50% if 10 years or less
• Age >30 years
• Seropositive for Human Immunodeficiency Virus (HIV)
• Patients consented to and registered on an upfront Children's Oncology Group (COG) AML study with a matched family donor

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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