Impact of Remission Induction Chemotherapy Prior to Allogeneic SCT in Relapsed and Poor-response Patients With AML
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Registration Number
- NCT02461537
- Lead Sponsor
- DKMS gemeinnützige GmbH
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 281
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RIST(remission induction) HAM high-dose cytarabine 3 g/m2 (days 1-3)/mitoxantrone 10mg/m2 (days 3-5) DISC (disease control) LDAC and/or Mitoxantrone low-dose cytarabine 20 mg/ m2 and /or mitoxantrone 10mg/m2
- Primary Outcome Measures
Name Time Method Disease-free survival on day 56 after allogeneic SCT Disease-free survival
- Secondary Outcome Measures
Name Time Method Overall survival 4 weeks, 8 weeks, and 24 weeks from randomization Overall survival
Rate of allogeneic transplantation 4 weeks, 8 weeks, and 16 weeks from randomization Rate of allogeneic transplantation
Incidence of CR at 4 weeks, 8 weeks, and 24 weeks from randomization Incidence of CR
Trial Locations
- Locations (18)
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Baden-Wuerttemberg, Germany
Klinikum Nürnberg Nord
🇩🇪Nürnberg, Bavaria, Germany
Universitätsklinikum Münster
🇩🇪Münster, North Rhine-Westphalia, Germany
Elblandkliniken Stiftung & Co. KG
🇩🇪Riesa, Saxony, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Universitätsmedizin Mannheim
🇩🇪Mannheim, Baden-Wuerttemberg, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Klinikum Augsburg
🇩🇪Augsburg, Bavaria, Germany
Rems-Murr-Kliniken gGmbH
🇩🇪Winnenden, Baden-Württemberg, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bavaria, Germany
Universitätsklinikum Aachen, AÖR
🇩🇪Aachen, Nordrhein-Westphalen, Germany
Universitätsklinikum Halle (Saale)
🇩🇪Halle, Saxony-Anhalt, Germany
Universitätsklinikum Essen (AöR)
🇩🇪Essen, Nordrhein-Westphalen, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Rhineland-Palatinate, Germany
University Hospital
🇩🇪Dresden, Saxony, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Saxony, Germany
Helios Klinikum Berlin Buch
🇩🇪Berlin, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Hessen, Germany