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A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

Unique Dataset IDNCT00049517
SponsorECOG-ACRIN Cancer Research GroupData ProviderECOG-ACRINTotal Study Enrolled Patients657Comparator (Control) Arm Enrolled Patients330Experimental (Active) Arm Enrolled Patients327RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeBiologics, Surgery, ChemotherapyDataset TypeOther

Clinical Trial Title

A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

Trial Summary and Conditions

RATIONALE: 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 can also be 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, multi-step 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.

Data Summary

Data from individual patients in both control and experimental arms are provided. Data files include information on baseline demographics, disease characteristics, efficacy, and mutation status.

Study Objectives

- To compare the overall survival (OS) between two induction regimens (standard versus dose intense daunorubicin and cytarabine) in patients with de novo AML - To compare disease-free survival (DFS) between two consolidation regimens - To compare overall survival between two consolidation regimens - To compare response rates between two induction arms - To evaluate the impact of allogeneic transplant on AML patients who have unfavorable prognostic factors - To evaluate the effect of autologous transplant on favorable and intermediate risk AML patients

Outcome Measures

overall survival, disease-free survival, response

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: EA E1900 Protocol.pdf

CRF: EA E1900 CRF.pdf

DATA DICTIONARY: EA E1900 Data Dictionary.pdf

DATA (ACTIVE ARM): EA_E1900_NCTNdata.csv