European registry for relapsed acute promyelocytic leukemia

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00006761
• Date of registration: 19/09/2014
• Prospective Registration: No
• Primary sponsor: III. Medizinische Universitätsklinik, Universitätsmedizin Mannheim
• Public title: European registry for relapsed acute promyelocytic leukemia
• Scientific title: European registry for relapsed acute promyelocytic leukemia - PROMYSE
• Date of first enrolment: 01/08/2008
• Target sample size: 250
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00006761
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment

Countries of recruitment

France, Germany, Greece, Italy, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Eva Lengfelder
• Affiliation: III. Medizinische Klinik, Universitätsmedizin Mannheim

• Name: Eva Lengfelder
• Affiliation: III. Medizinische Klinik, Universitätsmedizin Mannheim

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

C92.4

Acute promyelocytic leukaemia [PML]

C92.4

Intervention(s)

Group 1: It is he aim of the registry, which was established under the auspices of the European LeukemiaNet (ELN) to register data of patients with relapsed APL on the European level. Participation is open for all interested European countries. Patients, who experience any APL relapse from the year 2003 onwards are eligible for inclusion in the registry (first or later, hematological, molecular, extramedullary relapse).
Therapy:
The therapy is not defined and is only at the discretion of the treating physician/center. If ATO-based therapy is considered, the administration should be performed according to the recommendation of the European expert group, available at the website of the ELN website and in der paper of Sanz et al (Haematologica 2005;90:1231-1235). Important Steps or therapy are the remission induction with ATO+/-ATRA followed by one consolidation course with ATO+ATRA. After consolidation the RT-PCR of PML-RARA is mandatory for further treatment decisions. For continuation of therapy with the aim to further stabilize the remission, various treatment options are available (allogeneic or autologous transplantation, intensified or dose-reduced chemotherapy, further ATO cycles or variable maintenance therapy), to be selected according to age and performance status of the patient, status of molecular remission, first remission duration, type of frontline therapy and donor availability.
Evaluation of data:
Data should be evaluated according to treatment groups with or without ATO and according to first or later relapse. Within these groups, the clinical course should be evaluated according to hematological, molecular and extramedullary relapse, The comparison of the outcome after allogeneic or autologous or without transplantation is important, as we

Primary Outcome(s)

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

Secondary Outcome(s)

The rate of hematological remission after induction therapy with ATO+/-ATRA in patients with first relapse of APL separated according to hematological, molecular and extramedullary relapse.
The rate of induction death in patients with first relapse of APL treated with ATO+/-ATRA separated according to hematological, molecular and extramedullary relapse.
The rate of molecular remission after two treatment courses with ATO+/-ATRA (induction and consolidation) in patients with first relapse of APL separated according to hematological, molecular and extramedullary relapse.

Overall survival of patients with first relapse of APL treated with ATO-based salvage therapy separated according to hematological, molecular and extramedullary relapse.
Event free survival of patients with first relapse of APL treated with ATO-based salvage therapy separated according to hematological, molecular and extramedullary relapse.
Relapse free survival of patients with first relapse of APL treated with ATO-based salvage therapy separated according to hematological, molecular and extramedullary relapse.
Cumulative incidence of relapse of patients with first relapse of APL treated with ATO-based salvage therapy separated according to hematological, molecular and extramedullary relapse.

Overall survival after allogeneic transplantation in patients treated with ATO in first relapse.
Overall survival after autologous transplantation in patients treated with ATO in first relapse.
Overall survival after treatment continuation without transplantation in first relapse.

Overall survival in patients with second or later relapse treated with ATO-based salvage therapy.
Overall survival in patients with first relapse treated with conventional ATRA plus chemotherapy.
Overall survival in patients with second or later relapse treated with conventional ATRA plus chemotherapy.

Side effects of ATO-based induction and consolidation therapy.
Side effects of ATRA-plus-chemotherapy-based induction and consolidation therapy.

Source(s) of Monetary Support

III. Medizinische Klinik, Universitätsmedizin Mannheim

Firma TEVA GmbH

Ethics review

Status: Approved
Approval date: 17/01/2008
Contact:

[e-mail]

Medizinische Ethik-Kommission II Medizinischen Fakultät Mannheim, Forschungsgebäude, Haus 42 - Ebene 3

[phone]

[e-mail]

Results

• Date Completed: 28/01/2015
• URL: http://drks.de/search/en/trial/DRKS00006761#studyResults