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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
March 2009
NCT00049517Uploaded 04-09-2017
Access via NCI by Request
PDS UID: nci-data-349
A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation
Provider Information
Provider Data DescriptionAs of November 6, 2017, there are two different datasets available for NCT00049517. This is NCT00049517-D2. NCT00049517-D1 and NCT00049517-D2 each contain the same clinical and mutation data. NCT00049517-D1 was the original submission. NCT00049517-D2 updated the original data submission to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00049517-D2 be used.
SponsorEastern Cooperative Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.
ConditionsLeukemia
Intervention TypeBiological: sargramostim
Drug: busulfan
Drug: cyclophosphamide
Drug: cytarabine
Drug: gemtuzumab ozogamicin (GO)
Drug: Daunorubicin
Procedure: Autologous HCT
Procedure: Allogeneic HCT
Drug(s)Drug: busulfan
Drug: cyclophosphamide
Drug: cytarabine
Drug: Daunorubicin
Drug: gemtuzumab ozogamicin (GO)
Total Enrolled657
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionStandard Daunorubicin Then Autologous HCT - Experimental
High-dose Daunorubicin Then Autologous HCT - Experimental
Standard Daunorubicin Then GO/Autologous HCT - Experimental
High-dose Daunorubicin Then GO/Autologous HCT - Experimental
Standard Daunorubicin Then Allogeneic HCT or no Consolidation - Active Comparator
High-dose Daunorubicin Then Allogeneic HCT or no Consolidation - Experimental
Secondary IDU10CA021115
PubMed (PMID)19776406
16996130
22855599
21415269
27446991
26755712
25772026
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Israel
Age Range16 Years to 60 Years (Child, Adult)
Files: NCT00049517-D2
Data DictionaryNCT00049517-D2-Data-Dictionary.pdf
DATANCT00049517-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00049517-D1
Data DictionaryNCT00049517-D1-Data-Dictionary.pdf
DATANCT00049517-D1-Dataset.csv
OTHERREADME.pdf
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