HTLV-1 Adult T-cell Lymphoma / Leukemia, HTLV-1 Infection, Lymphoproliferation Induced by HTLV-1
Conditions
Keywords
Human T-lymphotropic Virus 1, lymphoma, leukemia
Brief 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).
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of survivors | Up to 1 year | for cohorts 1 and 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAmbroise MARCAIS, MD
Assistance Publique-Hôpitaux Paris
Outcome results
None listed