C92.4
Conditions
Interventions
Group 1: It is he aim of the registry, which was established under the auspices of the European LeukemiaNet (ELN) to register data of patients with relapsed APL on the European level. Participation is
90:1231-1235). Important Steps or therapy are the remission induction with ATO+/-ATRA followed by one consolidation course with ATO+ATRA. After consolidation the RT-PCR of PML-RARA is mandatory for fu
Sponsors
III. Medizinische Universitätsklinik, Universitätsmedizin Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients in first or subsequent hematological or molecular or extramedullary relapse of APL, persistence of positive PCR after front-line consolidation therapy, no complete hematological remission after front-line therapy (rare cases). Genetic confirmation of relapse of APL (RT-PCR, cytogenetics, FISH). Written confirmed consent of the patient to be rgistered. Date of relapse from 1, Januar 2003 onwards.
Exclusion criteria
Exclusion criteria: No genetic confirmation of APL relapse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of hematological remission after induction therapy with ATO+/-ATRA in patients with first relapse of APL. The rate of induction death in patients with first relapse of APL treated with ATO+/-ATRA. The rate of molecular remission after two treatment courses with ATO+/-ATRA (induction and consolidation) in patients with first relapse of APL. Overall survival of patients with first relapse of APL treated with ATO-based salvage therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of hematological remission after induction therapy with ATO+/-ATRA in patients with first relapse of APL separated according to hematological, molecular and extramedullary relapse. The rate of induction death in patients with first relapse of APL treated with ATO+/-ATRA separated according to hematological, molecular and extramedullary relapse. The rate of molecular remission after two treatment courses with ATO+/-ATRA (induction and consolidation) in patients with first relapse of APL separated according to hematological, molecular and extramedullary relapse. Overall survival of patients with first relapse of APL treated with ATO-based salvage therapy separated according to hematological, molecular and extramedullary relapse. Event free survival of patients with first relapse of APL treated with ATO-based salvage therapy separated according to hematological, molecular and extramedullary relapse. Relapse free survival of patients with first relapse of APL treated with ATO-based salvage therapy separated according to hematological, molecular and extramedullary relapse. Cumulative incidence of relapse of patients with first relapse of APL treated with ATO-based salvage therapy separated according to hematological, molecular and extramedullary relapse. Overall survival after allogeneic transplantation in patients treated with ATO in first relapse. Overall survival after autologous transplantation in patients treated with ATO in first relapse. Overall survival after treatment continuation without transplantation in first relapse. Overall survival in patients with second or later relapse treated with ATO-based salvage therapy. Overall survival in patients with first relapse treated with conventional ATRA plus chemotherapy. Overall survival in patients with second or later relapse treated with conventional ATRA plus chemotherapy. Side effects of ATO-based induction and consolidation therapy. Side effects of ATRA-plus-chemotherapy-based induction | — |
Countries
France, Germany, Greece, Italy, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactEva Lengfelder
III. Medizinische Klinik, Universitätsmedizin Mannheim
Outcome results
None listed