Prolymphocytic LeukemiaT-PLLNCT04411043
Observatory of Prolymphocytic Leukemia T
An observational study of Prolymphocytic Leukemia and T-cell Leukemia, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolymphocytic Leukemia, T-cell Leukemia
- What is being tested?
- Molecular caracterization
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 31 Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient with prolymphocytic T leukemia
Who may be able to join
- Man or woman aged 18 or over
- Patient with prolymphocytic T leukemia
Who cannot join
- Absence of signature of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T. A FILO Study.
Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-, CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + / CD8-, but also CD4 + / CD8 + or CD8 + / CD4-.
The main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1.
Read more
On the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational activation of the IL2RG-JAK1-JAK3-STAT5B axis.
Patients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has considerably improved the results, but the responses to treatment are transient; therefore, patients who obtain a response to alemtuzumab treatment are candidates for stem cell allograft (TSS) if they are eligible for this procedure. This combined approach extended the median survival to four years or more. However, new approaches using well-tolerated therapies that target signaling and survival pathways are necessary for most patients who are unable to receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 .
Main objective: Better manage prolymphocytic T leukemias.
Secondary objectives:
- Molecular characterization of prolymphocytic leukemia T.
- Study of the response to treatment, disease-free survival, overall survival.
- Impact of prognostic factors on response to treatment, and survival.
- Conditions
- Prolymphocytic Leukemia, T-cell Leukemia
- Being tested
- Molecular caracterization
- Medical subject headings
- Leukemia, Prolymphocytic, Leukemia, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular caracterizationBehavioural
Prospective and retrospective study evaluating the epidemiological, clinical, molecular and therapeutic data of prolymphocytic leukemias T
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics of prolymphocytic leukemia T
pathology description at diagnosis and its evolution over time
Measured: from day 0 through study completion, an average of 3 years
Biological characteristics of prolymphocytic leukemia T
Blood count : Hemoglobin, Leukocytes, Lymphocytes, Platelets, Eosinophils (giga / liters)
Measured: At day 0 and at relapse, an average of 3 years
Flow cytometry data of bone marrow and blood cells
Positive or negative immunophenotyping
Measured: At day 0 and at relapse, an average of 3 years
karyotype of tumor cells
karyotipic formula
Measured: At day 0 and at relapse, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Jul 2020
- Primary completion30 Jul 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolymphocytic LeukemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Kamel LARIBI, Dr, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411043
- Sponsor's protocol ID
- T-PLL
- Acronym
- T-PLL
- Status last verified
- Oct 2026
- First submitted
- 13 May 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T. A FILO Study.
- ClinicalTrials.gov ID
- NCT04411043
- Acronym / sponsor ID
- T-PLL / T-PLL
- Conditions
- Prolymphocytic Leukemia, T-cell Leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2020 (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.
Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-, CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + / CD8-, but also CD4 + / CD8 + or CD8 + / CD4-.
The main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1.
On the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational activation of the IL2RG-JAK1-JAK3-STAT5B axis.
Patients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has considerably improved the results, but the responses to treatment are transient; therefore, patients who obtain a response to alemtuzumab treatment are candidates for stem cell allograft (TSS) if they are eligible for this procedure. This combined approach extended the median survival to four years or more. However, new approaches using well-tolerated therapies that target signaling and survival pathways are necessary for most patients who are unable to receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 .
Main objective: Better manage prolymphocytic T leukemias.
Secondary objectives:
- Molecular characterization of prolymphocytic leukemia T.
- Study of the response to treatment, disease-free survival, overall survival.
- Impact of prognostic factors on response to treatment, and survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with prolymphocytic T leukemia
Key inclusion criteria (2 listed)
- Man or woman aged 18 or over
- Patient with prolymphocytic T leukemia
Key exclusion criteria (1 listed)
- Absence of signature of informed consent
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 |
|---|---|---|
| Molecular caracterizationProspective and retrospective study evaluating the epidemiological, clinical, molecular and therapeutic data of prolymphocytic leukemias T | Behavioural | – |
Primary outcome
Clinical characteristics of prolymphocytic leukemia T
Time frame: from day 0 through study completion, an average of 3 years
pathology description at diagnosis and its evolution over time
Biological characteristics of prolymphocytic leukemia T
Time frame: At day 0 and at relapse, an average of 3 years
Blood count : Hemoglobin, Leukocytes, Lymphocytes, Platelets, Eosinophils (giga / liters)
Flow cytometry data of bone marrow and blood cells
Time frame: At day 0 and at relapse, an average of 3 years
Positive or negative immunophenotyping
karyotype of tumor cells
Time frame: At day 0 and at relapse, an average of 3 years
karyotipic formula
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Kamel LARIBI, Dr principal investigator
French Innovative Leukemia Organisation
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 Prolymphocytic Leukemia and T-cell Leukemia, run by French Innovative Leukemia Organisation 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 2 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics of prolymphocytic leukemia T (time frame: from day 0 through study completion, an average of 3 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?
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 19 Oct 2026.