Prospecive study for treatment of acute promyelocytic leukemia (APL) with all-trans retinoic acid (ATRA) and chemotherapy
Phase 3
- Conditions
- C92.4Acute promyelocytic leukaemia [PML]
- Registration Number
- DRKS00004314
- Lead Sponsor
- niversitätsklinikum Münster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 189
Inclusion Criteria
Newly diagnosed APL, cytogenetically or molecularly confirmed, age over 16 years, written informed consent
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the effectiveness of the therapy<br>Main parameters:<br>Rate of complete remission<br>Overall survival at 6 years<br>Relapse free survival at 6 years<br>Event free survival at 6 years. <br>
- Secondary Outcome Measures
Name Time Method Rate of early death<br>Toxicity (in particular rate of infections WHO grade =3)<br>Monitoring of minimal residual disease by RT-PCR)<br>