This trial compares outcome of two treatment strategies for patients with high-risk AML who failed to achieve or maintain a complete remission with standard therapy. Patients will be randomized between two strategies. The standard strategy is aimed at achieving a complete remission by aggressive salvage chemotherapy using high dose cytarabine and mitoxantrone, . The alternative is a less toxic disease-control strategy of disease monitoring and, if necessary, low-dose cytarabine or mitoxantrone prior to allogeneic transplantation, which should be performed as soon as possible.
Patients with high-risk acute myeloid leukemia (AML) who relapsed or showed a poor response to induction chemotherapy have a dismal prognosis. For these patients, allogeneic transplantation is the recommended treatment. While allogeneic transplantation may be considered as the ultimate treatment concept, the treatment path to transplantation is not well defined. The traditional approach to pursue a complete remission by means of aggressive reinduction chemotherapy prior to allogeneic transplantation. This approach is associated with potentially life-threatening toxicities and has limited efficacy. As a result, only some patients will reach allogeneic transplantation in complete remission. To reduce the number of patients who die or who are ineligible for transplantation due to the toxicity of aggressive induction chemotherapy, other bridging options have been explored. One promising alternative is to abstain from remission induction. Instead, disease control by means of less aggressive chemotherapy or simply monitoring leukemic proliferation can be considered. This randomized trial will identify if there is non-inferiority of the less toxic approach, compared to the standard approach of remission induction by aggressive chemotherapy prior to allogeneic transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
281
High-dose cytarabine 1 - 3 g/m2 (days 1-3)/Mitoxantrone 20 mg/m2 (days3-5)
Low-dose cytarabine 20 mg/m2 (days 1-10) and/ or mitoxantrone 10mg/m2 (max 3 doses)
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Rems-Murr-Kliniken gGmbH
Winnenden, Baden-Wurttemberg, Germany
Klinikum Augsburg
Augsburg, Bavaria, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum Nürnberg Nord
Nuremberg, Bavaria, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Aachen, AÖR
Aachen, Nordrhein-Westphalen, Germany
...and 8 more locations
Disease-free survival
Disease-free survival
Time frame: on day 56 after allogeneic SCT
Overall survival
Overall survival
Time frame: 4 weeks, 8 weeks, and 24 weeks from randomization
Rate of allogeneic transplantation
Rate of allogeneic transplantation
Time frame: 4 weeks, 8 weeks, and 16 weeks from randomization
Incidence of CR
Incidence of CR
Time frame: at 4 weeks, 8 weeks, and 24 weeks from randomization
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