Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00416598|
Recruitment Status : Active, not recruiting
First Posted : December 28, 2006
Results First Posted : February 20, 2014
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||546 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 15, 2006|
|Actual Primary Completion Date :||January 31, 2011|
Experimental: Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
Procedure: Autologous Bone Marrow Transplantation
Undergo autologous bone marrow transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSC transplantation
Drug: Daunorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416598
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|Principal Investigator:||William Blum||Alliance for Clinical Trials in Oncology|