Study Title
Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes (NCT00028899)
Trial Description
Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as the antibody-drug conjugates or ADCs gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories), can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more cancer cells.
Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
This trial is sponsored by Children’s Oncology Group/ National Cancer Institute (NCI). [1]
Study Data
- Condition:
- Leukemia
- Myelodysplastic Syndromes
- Interventions:
- Drugs used in this trial
- asparaginase (Elspar®; Merck & Co.)
- cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals)
- gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories)
- mitoxantrone hydrochloride (Novantrone®; EMD Serono/Merck & Co.)
- Drugs used in this trial
- Phase: I
- Enrollment: 47
- Start: July 2002
- Completion: March 2012
- Last verified: February 2014
Study Schematic
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Last Editorial review: July 23, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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