Anaplastic LymphomaLEUK-ALCLNCT04908059
Leukemic Phase of ALCL
An observational study of Anaplastic Lymphoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Collecting data about the rare leukemic presentation of anaplastic lymphoma to study the characteristics of patients with leukemic phase of ALCL Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Anaplastic Lymphoma
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2021to 13 Jul 2021
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting a leukemic phase of anaplastic lymphoma
Who may be able to join
- Patients presenting a leukemic phase of anaplastic lymphoma
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hematology Laboratory - Strasbourg University Hospitals
Strasbourg, 67091
Laurent MAUVIEUX, MD, PhD, 33 3 88 12 75 27, laurent.mauvieux@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Leukemic Phase of ALK+ Anaplastic Lymphoma in Real-life Practice: Experience of a University Clinical Hematology Laboratory
Collecting data about the rare leukemic presentation of anaplastic lymphoma to study the characteristics of patients with leukemic phase of ALCL
- Conditions
- Anaplastic Lymphoma
- Keywords
- Anaplastic lymphoma, Leukemic phase
What is being measured
The primary outcome is the main question the study is designed to answer.
A retrospective study of the diagnostic description of the leukemic phases of anaplastic lymphoma in real life
Measured: Files analysed retrospectively from January 01, 2020 to December 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start27 Jan 2021
- Primary completion13 Jul 2021 (estimated)
- Study completion13 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent MAUVIEUX, MD, PhD, Study director, Hematology Laboratory - Strasbourg University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908059
- Sponsor's protocol ID
- 8115
- Acronym
- LEUK-ALCL
- Status last verified
- May 2021
- First submitted
- 26 May 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukemic Phase of ALK+ Anaplastic Lymphoma in Real-life Practice: Experience of a University Clinical Hematology Laboratory
- ClinicalTrials.gov ID
- NCT04908059
- Acronym / sponsor ID
- LEUK-ALCL / 8115
- Conditions
- Anaplastic Lymphoma
- Keywords
- Anaplastic lymphoma, Leukemic phase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 13 Jul 2021 (estimated)
- Study completion
- 13 Jul 2021 (estimated)
- First posted
- 1 Jun 2021 (actual)
- 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.
Collecting data about the rare leukemic presentation of anaplastic lymphoma to study the characteristics of patients with leukemic phase of ALCL
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting a leukemic phase of anaplastic lymphoma
Key inclusion criteria (1 listed)
- Patients presenting a leukemic phase of anaplastic lymphoma
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.
Primary outcome
A retrospective study of the diagnostic description of the leukemic phases of anaplastic lymphoma in real life
Time frame: Files analysed retrospectively from January 01, 2020 to December 31, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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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.
Laurent MAUVIEUX, MD, PhD study director
Hematology Laboratory - Strasbourg University Hospitals
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 Anaplastic Lymphoma, run by University Hospital, Strasbourg, France at 1 site in France.
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 1 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 8 Jul 2021. 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 France. 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 Laurent MAUVIEUX, MD, PhD (33 3 88 12 75 27, laurent.mauvieux@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A retrospective study of the diagnostic description of the leukemic phases of anaplastic lymphoma in real life (time frame: Files analysed retrospectively from January 01, 2020 to December 31, 2020 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2021.