Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
|Acute Myeloid Leukemia With Myelodysplasia-Related Changes Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A Untreated Adult Acute Myeloid Leukemia||Procedure: Autologous Bone Marrow Transplantation Procedure: Autologous Hematopoietic Stem Cell Transplantation Drug: Busulfan Drug: Cytarabine Drug: Daunorubicin Hydrochloride Drug: Decitabine Drug: Etoposide Biological: Filgrastim Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Maintenance Therapy With Decitabine (NSC #127716) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years|
- Number of Participants Who Completed Maintenance Decitabine. [ Time Frame: Up to 5 years ]To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.
- Disease-free Survival (DFS) Rate at 1 Year [ Time Frame: At 1 year ]
For participants who achieved a complete remission (CR), this is the percentage of participants who were alive and relapse free at 1 year. The 1 year rate, with 95% confidence interval, was estimated using the Kaplan-Meier method
A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL).
- Relationship Between Busulfan Pharmacokinetics (Area Under the Curve) and Relapsed Disease [ Time Frame: At baseline, after 2, 4, and 6 hours after the start of busulfan infusion ]Results from busulfan pharmacokinetics will be pooled with those from CALGB 19808.
|Actual Study Start Date:||November 15, 2006|
|Primary Completion Date:||January 31, 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
Procedure: Autologous Bone Marrow Transplantation
Undergo autologous bone marrow transplantation
Other Names:Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSC transplantation
Other Names:Drug: Busulfan
Other Names:Drug: Cytarabine
Other Names:Drug: Daunorubicin Hydrochloride
Other Names:Drug: Decitabine
Other Names:Drug: Etoposide
Other Names:Biological: Filgrastim
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416598
Show 40 Study Locations
|Principal Investigator:||William Blum||Alliance for Clinical Trials in Oncology|