C92.4
Conditions
Interventions
Group 1: The treatment concept consists of induction therapy (double induction), consolidation therapy and maintenance therapy. The treatment intensification is stratified according to the age of the
Sponsors
Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: Newly diagnosed APL, cytogenetically or molecularly confirmed, age over 16 years, written informed consent
Exclusion criteria
Exclusion criteria: Cardiac failure NYHA III und IV, chronic pumonary diasease with hypoxemia, severe treatment refractory hypertension, renal failure, if not explained by leukemia (serum creatinine 2 mg/ 100 ml or more), severe chronic liver disease, uncontrolled pneumonia with hypoxemia, uncontrolled sepsis, uncontrolled life-threatening bleeding, psycatric disorder, frailty befor onset of leukemia, cachexia, pregnancy, secondary malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the effectiveness of the therapy Main parameters: Rate of complete remission Overall survival at 6 years Relapse free survival at 6 years Event free survival at 6 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of early death Toxicity (in particular rate of infections WHO grade =3) Monitoring of minimal residual disease by RT-PCR) | — |
Countries
Germany
Contacts
Public ContactEva Lengfelder
III. Medizinische Klinik, Universitätsmedizin Mannheim
Outcome results
None listed