Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (AML-AZA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00915252|
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : December 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: azacitidine Drug: standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Multi-center Phase II Trial to Assess the Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Patients enrolled in this arm will receive standard induction and consolidation chemotherapy preceded by 5-azacytidine. These patients will additionally receive maintenance therapy with 5-azacytidine for one year after start of induction therapy.
Starting dose has been determined during run-in dose finding part of the study. Starting dose of the interventional drug is 75 mg/m²/d. Application form:
During induction therapy phase: i.v. on days -5--1 before standard chemotherapy for 1 or 2 cycles, During consolidation therapy: s.c. on days -5--1 before standard chemotherapy (2 cycles).
During maintenance therapy: s.c. on days 1-5 on a 28day cycle till maximum one year after start of first induction therapy.
Active Comparator: standard chemotherapy
Patients enrolled in this arm will receive standard chemotherapy treatment.
Drug: standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine
Daunorubicin 60mg/m²/d i.v.on days 3,4,5 AraC 100mg/m²/d i.v. on days 1-7
AraC 1g/m² twice a day on day 1,3,5
- Median Event Free Survival (EFS) of all AML patients [ Time Frame: continously up to 12 months after start of study ]
- Median event free survival of AML patients with different cytogenetic and molecular risk groups [ Time Frame: continously up to 12 months after study start ]
- Median overall survival of all AML patients [ Time Frame: continously up to 12 month after start of study ]
- Median overall survival of AML patients with different cytogenetic and molecular risk groups [ Time Frame: continously up to 12 month after start of study ]
- Relapse free survival [ Time Frame: continously up to 12 months after start of study ]
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): NCT00915252
|Principal Investigator:||Carsten Müller-Tidow, MD||Universitätsklinikum Münster, Medizinische Klinik A|