HTLV-1 Infection Clinical Trial
— HTLV-OBSOfficial 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).
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | March 2027 |
| Est. primary completion date | March 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Necker Enfants Malades | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of survivors | for cohorts 1 and 2 | Up to 1 year | |
| Secondary | Number of survivors at 2 years | for cohorts 1 and 2 | At 2 years | |
| Secondary | Number of survivors at 5 years | for cohorts 1 and 2 | 5 years | |
| Secondary | HTLV-1 proviral load | for cohorts 1 and 2 | day 1 | |
| Secondary | viral integration profile | for cohorts 1 and 2 | day 1 | |
| Secondary | lymphocyte phenotyping of tumor cells | for cohorts 1 and 2 | day 1 | |
| Secondary | genetic analysis of tumor cells by Next-generation sequencing (NGS) | for cohorts 1 and 2 | day 1 | |
| Secondary | number of patients with HTLV-1-related hematological disorders | for cohort 1 | day 1 | |
| Secondary | number of patients with HTLV-1-related extra-hematological disorders | for cohort 1 | day 1 | |
| Secondary | types of ATL | According the Shimoyama classification (smoldering, chronic, Acute and Lymphoma) for cohort 1 | day 1 | |
| Secondary | Treatment lines | Chemotherapy type, number of Chemotherapy cycles, efficacity of Chemotherapy : Number of complete remissions following treatment : for cohort 1 | during 5 years | |
| Secondary | Response to induction therapy | according to established response criteria for ATL for cohort 1 | during 5 years | |
| Secondary | Progression free survival (PFS) | for cohort 1 | during 5 years | |
| Secondary | relapse-related mortality | for cohort 1 | during 5 years | |
| Secondary | chemotherapy-related mortality | for cohort 1 | during 5 years | |
| Secondary | transplant-related mortality | for cohort 1 | during 5 years | |
| Secondary | Number of serious adverse events according to WHO classification related to treatment received | for cohort 1 | during 5 years | |
| Secondary | Allograft-specific characteristic | (donor type, conditioning type, engraftment, graft-related mortality) for cohort 1 | during 5 years | |
| Secondary | number of progression to ATL | at 2 years | ||
| Secondary | Number of progression to ATL | At 5 years | ||
| Secondary | number of patients with HTLV-1-related extrahematological disorders | during 5 years | ||
| Secondary | Number of patients with corticotherapy for extrahematological complications | Dose of corticotherapy for extrahematological complications, number of days with corticotherapy for extrahematological complications | during 5 years | |
| Secondary | Number of Serious adverse events according to WHO classification related to treatment received | during 5 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03075553 -
Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
|
Phase 2 | |
| Completed |
NCT01581567 -
Neuroimmunology Branch Repository
|
||
| Completed |
NCT02631746 -
Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/Lymphoma
|
Phase 2 | |
| Recruiting |
NCT04301076 -
Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATL)
|
Phase 1 |