Lymphoproliferation Induced by HTLV-1HTLV-OBSNCT05237245
Clinico-biological Characterization and Survival of Patients With Adult T-cell Leukemia / Lymphoma (ATL) and Patients Chronically Infected With the HTLV-1 Virus (HTLV-OBS)
An observational study of Lymphoproliferation Induced by HTLV-1 and HTLV-1 Adult T-cell Lymphoma / Leukemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the outcome (survival) of Adult T-cell leukemia / lymphoma (ATL) patients who receive or not specific treatment for their hemopathy (cohort 1) and the outcome (survival) of HTLV-1 chronically infected patients with / without extra-haematological disorders (cohort 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoproliferation Induced by HTLV-1, HTLV-1 Adult T-cell Lymphoma / Leukemia, HTLV-1 Infection
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2022to Mar 2027
- 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: Adult patients with lymphoproliferation induced by HTLV-1 (or HTLV-1 adult T-cell lymphoma / leukemia) and HTLV-1 infected patients
Who may be able to join
- 18 years old or older
- HTLV-1 infected
- T lymphoproliferation induced by HTLV-1 (cohort 1)
- without T lymphoproliferation induced by HTLV-1 (cohort 2)
- informed and accepted the collection of data
Who cannot join
- Patients refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caractérisation Clinico- Biologique et Survie Des Patients Porteurs d'Une lymphoprolifération HTLV-1 Induite (ou Lymphome/leucémie lié au Virus HTLV-1) et Des Patients infectés Par le Virus HTLV-1
The purpose of this study is to evaluate the outcome (survival) of Adult T-cell leukemia / lymphoma (ATL) patients who receive or not specific treatment for their hemopathy (cohort 1) and the outcome (survival) of HTLV-1 chronically infected patients with / without extra-haematological disorders (cohort 2).
- Conditions
- Lymphoproliferation Induced by HTLV-1, HTLV-1 Adult T-cell Lymphoma / Leukemia, HTLV-1 Infection
- Keywords
- Human T-lymphotropic Virus 1, lymphoma, leukemia
- Medical subject headings
- Leukemia, HTLV-I Infections, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Adult T-cell leukemia / lymphoma (ATL) patients | |
| 2 | HTLV-1 chronically infected patients without ATL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of survivors
for cohorts 1 and 2
Measured: Up to 1 year
Secondary outcomes (22)
Number of survivors at 2 years
for cohorts 1 and 2
Measured: At 2 years
Number of survivors at 5 years
for cohorts 1 and 2
Measured: 5 years
HTLV-1 proviral load
for cohorts 1 and 2
Measured: day 1
viral integration profile
for cohorts 1 and 2
Measured: day 1
lymphocyte phenotyping of tumor cells
for cohorts 1 and 2
Measured: day 1
genetic analysis of tumor cells by Next-generation sequencing (NGS)
for cohorts 1 and 2
Measured: day 1
number of patients with HTLV-1-related hematological disorders
for cohort 1
Measured: day 1
number of patients with HTLV-1-related extra-hematological disorders
for cohort 1
Measured: day 1
types of ATL
According the Shimoyama classification (smoldering, chronic, Acute and Lymphoma) for cohort 1
Measured: day 1
Treatment lines
Chemotherapy type, number of Chemotherapy cycles, efficacity of Chemotherapy : Number of complete remissions following treatment : for cohort 1
Measured: during 5 years
Response to induction therapy
according to established response criteria for ATL for cohort 1
Measured: during 5 years
Progression free survival (PFS)
for cohort 1
Measured: during 5 years
relapse-related mortality
for cohort 1
Measured: during 5 years
chemotherapy-related mortality
for cohort 1
Measured: during 5 years
transplant-related mortality
for cohort 1
Measured: during 5 years
Number of serious adverse events according to WHO classification related to treatment received
for cohort 1
Measured: during 5 years
Allograft-specific characteristic
(donor type, conditioning type, engraftment, graft-related mortality) for cohort 1
Measured: during 5 years
number of progression to ATL
Measured: at 2 years
Number of progression to ATL
Measured: At 5 years
number of patients with HTLV-1-related extrahematological disorders
Measured: during 5 years
Number of patients with corticotherapy for extrahematological complications
Dose of corticotherapy for extrahematological complications, number of days with corticotherapy for extrahematological complications
Measured: during 5 years
Number of Serious adverse events according to WHO classification related to treatment received
Measured: during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start23 Mar 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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 Lymphoproliferation Induced by HTLV-1Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Ambroise MARCAIS, MD, Principal investigator, Assistance Publique-Hôpitaux Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237245
- Sponsor's protocol ID
- APHP180684
- Other IDs
- 2020-A02320-39
- Acronym
- HTLV-OBS
- Status last verified
- Mar 2026
- First submitted
- 20 Dec 2021
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marcais A, Lhermitte L, Avettand Fenoel V, Ouedrani A, Loiseau C, Cazelles C, Naveau L, Gilbert A, Debus L, Helias P, Mariaggi AA, Gournay V, Caillon C, Ingen-Housz-Oro S, Corvilain E, Damaj GL, Nguyen S, Aubert P, Loschi M, Asnafi V, Suarez F, Hermine O. Allogeneic stem cell transplantation in aggressive Adult T cell leukemia/lymphoma: a prospective multicenter study. Blood Adv. 2026 Oct 7:bloodadvances.2026020323. doi: 10.1182/bloodadvances.2026020323. Online ahead of print.
PubMed 42843318
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caractérisation Clinico- Biologique et Survie Des Patients Porteurs d'Une lymphoprolifération HTLV-1 Induite (ou Lymphome/leucémie lié au Virus HTLV-1) et Des Patients infectés Par le Virus HTLV-1
- ClinicalTrials.gov ID
- NCT05237245
- Acronym / sponsor ID
- HTLV-OBS / APHP180684
- Conditions
- Lymphoproliferation Induced by HTLV-1, HTLV-1 Adult T-cell Lymphoma / Leukemia, HTLV-1 Infection
- Keywords
- Human T-lymphotropic Virus 1, lymphoma, leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Feb 2022 (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.
The purpose of this study is to evaluate the outcome (survival) of Adult T-cell leukemia / lymphoma (ATL) patients who receive or not specific treatment for their hemopathy (cohort 1) and the outcome (survival) of HTLV-1 chronically infected patients with / without extra-haematological disorders (cohort 2).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adult T-cell leukemia / lymphoma (ATL) patients |
| 2 | – | –HTLV-1 chronically infected patients without ATL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with lymphoproliferation induced by HTLV-1 (or HTLV-1 adult T-cell lymphoma / leukemia) and HTLV-1 infected patients
Key inclusion criteria (5 listed)
- 18 years old or older
- HTLV-1 infected
- T lymphoproliferation induced by HTLV-1 (cohort 1)
- without T lymphoproliferation induced by HTLV-1 (cohort 2)
- informed and accepted the collection of data
Key exclusion criteria (1 listed)
- Patients refusal of participation
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
Number of survivors
Time frame: Up to 1 year
for cohorts 1 and 2
22 secondary outcomes
Number of survivors at 2 years
Time frame: At 2 years
Number of survivors at 5 years
Time frame: 5 years
HTLV-1 proviral load
Time frame: day 1
viral integration profile
Time frame: day 1
lymphocyte phenotyping of tumor cells
Time frame: day 1
genetic analysis of tumor cells by Next-generation sequencing (NGS)
Time frame: day 1
number of patients with HTLV-1-related hematological disorders
Time frame: day 1
number of patients with HTLV-1-related extra-hematological disorders
Time frame: day 1
types of ATL
Time frame: day 1
Treatment lines
Time frame: during 5 years
Response to induction therapy
Time frame: during 5 years
Progression free survival (PFS)
Time frame: during 5 years
relapse-related mortality
Time frame: during 5 years
chemotherapy-related mortality
Time frame: during 5 years
transplant-related mortality
Time frame: during 5 years
Number of serious adverse events according to WHO classification related to treatment received
Time frame: during 5 years
Allograft-specific characteristic
Time frame: during 5 years
number of progression to ATL
Time frame: at 2 years
Number of progression to ATL
Time frame: At 5 years
number of patients with HTLV-1-related extrahematological disorders
Time frame: during 5 years
Number of patients with corticotherapy for extrahematological complications
Time frame: during 5 years
Number of Serious adverse events according to WHO classification related to treatment received
Time frame: during 5 years
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 25 Mar 2026.
- Derived from this study: PubMed 42843318Marcais A, Lhermitte L, Avettand Fenoel V, Ouedrani A, Loiseau C, Cazelles C, Naveau L, Gilbert A, Debus L, Helias P, Mariaggi AA, Gournay V, Caillon C, Ingen-Housz-Oro S, Corvilain E, Damaj GL, Nguyen S, Aubert P, Loschi M, Asnafi V, Suarez F, Hermine O. Allogeneic stem cell transplantation in aggressive Adult T cell leukemia/lymphoma: a prospective multicenter study. Blood Adv. 2026 Oct 7:bloodadvances.2026020323. doi: 10.1182/bloodadvances.2026020323. Online ahead of print.
- Individual participant dataSharing planned: No
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.
Ambroise MARCAIS, MD principal investigator
Assistance Publique-Hôpitaux Paris
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 Lymphoproliferation Induced by HTLV-1 and HTLV-1 Adult T-cell Lymphoma / Leukemia, run by Assistance Publique - Hôpitaux de Paris 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 5 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 25 Mar 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?
Number of survivors (time frame: Up to 1 year). 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 NCT05237245, 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 25 Mar 2026.