European registry for relapsed acute promyelocytic leukemia

• Conditions: C92.4; Acute promyelocytic leukaemia [PML]

• Registration Number: DRKS00006761
• Lead Sponsor: III. Medizinische Universitätsklinik, Universitätsmedizin Mannheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-19
• Study Completion: 2015-01-28
• Results First Posted: 2015-01-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 155

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

No genetic confirmation of APL relapse.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of hematological remission after induction therapy with ATO+/-ATRA in patients with first relapse of APL. <br>The rate of induction death in patients with first relapse of APL treated with ATO+/-ATRA.<br>The rate of molecular remission after two treatment courses with ATO+/-ATRA (induction and consolidation) in patients with first relapse of APL.<br>Overall survival of patients with first relapse of APL treated with ATO-based salvage therapy.<br>