Randomized comparison of two different treatment concepts in newly diagnosed acute promyelocytic leukemia (APL).A randomized study for comparison of the effects of ATRA and intensified double induction therapy incorporating high dose ara-C followed by TAD consolidation and cyclic maintenance therapy (AMLCG concept) and induction therapy with ATRA and idarubicin (AIDA) followed by three anthracyclin/ATRA- based consloidation courses and maintenance therapy (PETHEMA conzept).
Phase 3
- Conditions
- C92.4Acute promyelocytic leukaemia [PML]
- Registration Number
- DRKS00004313
- Lead Sponsor
- niversitätsklinikum Mannheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
Newly diagnosed APL (AML FAB M3 or M3v), molecularly or cytogeneticall confirmed,
Age 16 years or older, no upper age limit,
written informed consent
Exclusion Criteria
Cardiac failure NYHA-Stadium III und IV,
Chronic pulmonary disease with hypoxemia,
severe treatment resistant hypertension,
renal disease (serum creatinine 2 mg/100 ml or more, if not caused by leukemic infiltration, sever liver disease, if not caused by leukemia, severe pneumonia in particular with hypoxemia, uncontrolled sepsis, uncontrolled life-threatening bleeding, psychiatric disorder, frailty before onset of leukemia, cachexia, pregnancy, active secondary malignancy, no informed consent.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the molecular and hematological remission rate, early death rate, toxicity, description of the kinetics of the minimal residual disease.<br><br><br><br>
- Secondary Outcome Measures
Name Time Method Relapse free survival, event free survival, overall survival, cumulative incidence of relapse after 2 years.