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
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All trials for Lymphoproliferation Induced by HTLV-1 All trials for HTLV-1 Adult T-cell Lymphoma / Leukemia
-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).
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| 1 | | | Adult T-cell leukemia / lymphoma (ATL) patients |
| 2 | | | HTLV-1 chronically infected patients without ATL |
+Outcome measures
Primary outcomes
- Number of survivors [Up to 1 year]: for cohorts 1 and 2
Secondary outcomes
- Number of survivors at 2 years [At 2 years]: for cohorts 1 and 2
- Number of survivors at 5 years [5 years]: for cohorts 1 and 2
- HTLV-1 proviral load [day 1]: for cohorts 1 and 2
- viral integration profile [day 1]: for cohorts 1 and 2
- lymphocyte phenotyping of tumor cells [day 1]: for cohorts 1 and 2
- genetic analysis of tumor cells by Next-generation sequencing (NGS) [day 1]: for cohorts 1 and 2
- number of patients with HTLV-1-related hematological disorders [day 1]: for cohort 1
- number of patients with HTLV-1-related extra-hematological disorders [day 1]: for cohort 1
- types of ATL [day 1]: According the Shimoyama classification (smoldering, chronic, Acute and Lymphoma) for cohort 1
- Treatment lines [during 5 years]: Chemotherapy type, number of Chemotherapy cycles, efficacity of Chemotherapy : Number of complete remissions following treatment : for cohort 1
- Response to induction therapy [during 5 years]: according to established response criteria for ATL for cohort 1
- Progression free survival (PFS) [during 5 years]: for cohort 1
- relapse-related mortality [during 5 years]: for cohort 1
- chemotherapy-related mortality [during 5 years]: for cohort 1
- transplant-related mortality [during 5 years]: for cohort 1
- Number of serious adverse events according to WHO classification related to treatment received [during 5 years]: for cohort 1
- Allograft-specific characteristic [during 5 years]: (donor type, conditioning type, engraftment, graft-related mortality) for cohort 1
- number of progression to ATL [at 2 years]
- Number of progression to ATL [At 5 years]
- number of patients with HTLV-1-related extrahematological disorders [during 5 years]
- Number of patients with corticotherapy for extrahematological complications [during 5 years]: Dose of corticotherapy for extrahematological complications, number of days with corticotherapy for extrahematological complications
- Number of Serious adverse events according to WHO classification related to treatment received [during 5 years]
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* 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
Exclusion Criteria
\- Patients refusal of participation
+Locations (1)
| Facility | City | Country | Status |
|---|
| Hôpital Necker Enfants Malades | Paris | France | |
+Publications
- Results publication: 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. PMID 42843318
+Investigators
- Ambroise MARCAIS, MD, Principal investigator, Assistance Publique-Hôpitaux Paris