drugset / Trial / NCT00077116

Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome

NCT00077116

RandomizedOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome.

Timeline

Start
2003-11
Primary completion
2006-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule
Subject Cyclophosphamide Other / unclassified
Subject Cytarabine Small molecule Intravenous
Subject Gemtuzumab Ozogamicin Monoclonal antibody Intravenous
Subject Idarubicin Small molecule Intravenous