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).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004313

Enrollment

100

Registered

2012-08-20

Start date

2005-11-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C92.4

Interventions

Group 1: AMLCG arm: The treatment concept consists of induction therapy (double induction), consolidation therapy and maintenance therapy. The treatment intensification is stratified according to the

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Assessment of the molecular and hematological remission rate, early death rate, toxicity, description of the kinetics of the minimal residual disease.	—

Secondary

Measure	Time frame
Relapse free survival, event free survival, overall survival, cumulative incidence of relapse after 2 years.	—

Countries

Germany

Contacts

Public ContactEva Lengfelder

III. Medizinische Klinik Universitätsmedizin Mannnheim

eva.lengfelder@umm.de0049 621 383-4131 oder 383-4115

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026