Newly-diagnosed APL (de Novo or Therapy-related)NCT02192619
National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
An observational study of Newly-diagnosed APL (de Novo or Therapy-related) and Relapsed APL, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 1 site in Germany.
Trial summary
The registry aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with APL. Additionally, a biobanking project for further translational studies is integrated. Prospective population-based non-interventional and non-randomized multicenter registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly-diagnosed APL (de Novo or Therapy-related), Relapsed APL
- What is being tested?
- observational
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly-diagnosed or relapsed APL (de novo or therapy-related) who require a therapeutic intervention according to their disease state are the study population within this registry.
Who may be able to join
- newly-diagnosed APL (either de novo or therapy-related), within 12 months of diagnosis
- or relapsed APL, within 12 months of diagnosis of relapse
- confirmed by the presence of the translocation t(15; 17)
- and / or confirmed by the detection of the fusion transcript of PML/RARa
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Prof. Dr. U. Platzbecker
Dresden, 01307
Uwe Platzbecker, Prof. Dr., +49 351 458 3192, Uwe.Platzbecker@medizin.uni-leipzig.de
Michaela Weier, +49 351 458 3192, michaela.weier@ukdd.de
About this study
The registry aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with APL. Additionally, a biobanking project for further translational studies is integrated.
Prospective population-based non-interventional and non-randomized multicenter registry.
Read the detailed description
- collection of epidemiological data for APL: age distribution, prognostic factors, distribution of subgroups, incidence
- documentation of efficacy and safety of the first line and salvage therapy in APL including
- documentation of minimal residual disease (MRD)
- correlation of clinical outcomes with chosen therapy
- collection and evaluation of quality of life
- validation of published prognostic factors / new potential prognostic factors
- acquisition of bone marrow, peripheral blood and buccal swab samples for biobanking and translational studies under the umbrella of the specific study-group biobanking concepts
- Being tested
- observational
- Keywords
- APL, acute promyelocytic leukemia, AML M3
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
| Study group | Role | What they receive |
|---|---|---|
| observational | Not described Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
epidemiological parameters
Measured: yearly follow up for 5 years
diagnostic quality indicators
Measured: yearly follow up for 5 years
type of therapy
Measured: yearly follow up for 5 years
response, recurrence and time of death and resulting outcomes RFS and OS
Measured: yearly follow up for 5 years
Secondary outcomes (5)
complete remission (CR) and CRm
Measured: yearly follow up for 5 years
treatment related mortality (TRM)
Measured: yearly follow up for 5 years
cumulative incidence of relapse (CIR)
Measured: yearly follow up for 5 years
grade IV toxicities
Measured: yearly follow up for 5 years
quality of life (QoL): EORTC QLQ-C30
Measured: yearly follow up for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newly-diagnosed APL (de Novo or Therapy-related)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard F. Schlenk, Prof. Dr., Principal investigator, Universitätsklinikum Ulm, for the AML-SG groupEva Lengfelder, PD Dr., Principal investigator, Universitätsklinikum MannheimDietger Niederwieser, Prof. Dr., Principal investigator, Universitätsklinikum Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192619
- Sponsor's protocol ID
- NAPOLEON-Registry
- Status last verified
- Feb 2024
- First submitted
- 11 Jul 2014
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Kayser S, Schlenk RF, Lebon D, Carre M, Gotze KS, Stolzel F, Berceanu A, Schafer-Eckart K, Peterlin P, Hicheri Y, Rahme R, Raffoux E, Chermat F, Krause SW, Aulitzky WE, Rigaudeau S, Noppeney R, Berthon C, Gorner M, Jost E, Carassou P, Keller U, Orvain C, Braun T, Saillard C, Arar A, Kunzmann V, Wemeau M, De Wit M, Niemann D, Bonmati C, Schwanen C, Abraham J, Aljijakli A, Haiat S, Kramer A, Reichle A, Gnadler M, Willekens C, Spiekermann K, Hiddemann W, Muller-Tidow C, Thiede C, Rollig C, Serve H, Bornhauser M, Baldus CD, Lengfelder E, Fenaux P, Platzbecker U, Ades L. Characteristics and outcome of patients with low-/intermediate-risk acute promyelocytic leukemia treated with arsenic trioxide: an international collaborative study. Haematologica. 2021 Dec 1;106(12):3100-3106. doi: 10.3324/haematol.2021.278722.
PubMed 34047178
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
- ClinicalTrials.gov ID
- NCT02192619
- Acronym / sponsor ID
- NAPOLEON-Registry
- Keywords
- APL, acute promyelocytic leukemia, AML M3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbHUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The registry aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with APL. Additionally, a biobanking project for further translational studies is integrated.
Prospective population-based non-interventional and non-randomized multicenter registry.
Detailed description
- collection of epidemiological data for APL: age distribution, prognostic factors, distribution of subgroups, incidence
- documentation of efficacy and safety of the first line and salvage therapy in APL including
- documentation of minimal residual disease (MRD)
- correlation of clinical outcomes with chosen therapy
- collection and evaluation of quality of life
- validation of published prognostic factors / new potential prognostic factors
- acquisition of bone marrow, peripheral blood and buccal swab samples for biobanking and translational studies under the umbrella of the specific study-group biobanking concepts
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | – | Other: observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly-diagnosed or relapsed APL (de novo or therapy-related) who require a therapeutic intervention according to their disease state are the study population within this registry.
Key inclusion criteria (4 listed)
- newly-diagnosed APL (either de novo or therapy-related), within 12 months of diagnosis
- or relapsed APL, within 12 months of diagnosis of relapse
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational | Other | observational |
Primary outcome
epidemiological parameters
Time frame: yearly follow up for 5 years
diagnostic quality indicators
Time frame: yearly follow up for 5 years
type of therapy
Time frame: yearly follow up for 5 years
response, recurrence and time of death and resulting outcomes RFS and OS
Time frame: yearly follow up for 5 years
5 secondary outcomes
complete remission (CR) and CRm
Time frame: yearly follow up for 5 years
treatment related mortality (TRM)
Time frame: yearly follow up for 5 years
cumulative incidence of relapse (CIR)
Time frame: yearly follow up for 5 years
grade IV toxicities
Time frame: yearly follow up for 5 years
quality of life (QoL): EORTC QLQ-C30
Time frame: yearly follow up for 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 34047178Kayser S, Schlenk RF, Lebon D, Carre M, Gotze KS, Stolzel F, Berceanu A, Schafer-Eckart K, Peterlin P, Hicheri Y, Rahme R, Raffoux E, Chermat F, Krause SW, Aulitzky WE, Rigaudeau S, Noppeney R, Berthon C, Gorner M, Jost E, Carassou P, Keller U, Orvain C, Braun T, Saillard C, Arar A, Kunzmann V, Wemeau M, De Wit M, Niemann D, Bonmati C, Schwanen C, Abraham J, Aljijakli A, Haiat S, Kramer A, Reichle A, Gnadler M, Willekens C, Spiekermann K, Hiddemann W, Muller-Tidow C, Thiede C, Rollig C, Serve H, Bornhauser M, Baldus CD, Lengfelder E, Fenaux P, Platzbecker U, Ades L. Characteristics and outcome of patients with low-/intermediate-risk acute promyelocytic leukemia treated with arsenic trioxide: an international collaborative study. Haematologica. 2021 Dec 1;106(12):3100-3106. doi: 10.3324/haematol.2021.278722.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard F. Schlenk, Prof. Dr. principal investigator
Universitätsklinikum Ulm, for the AML-SG group
Eva Lengfelder, PD Dr. principal investigator
Universitätsklinikum Mannheim
Dietger Niederwieser, Prof. Dr. principal investigator
Universitätsklinikum Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly-diagnosed APL (de Novo or Therapy-related) and Relapsed APL, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uwe Platzbecker, Prof. Dr. (+49 351 458 3192, Uwe.Platzbecker@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epidemiological parameters (time frame: yearly follow up for 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02192619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.