Patient's Outcome Prognostic Factors Clinical Trial
Official title:
Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era
| NCT number | NCT03663894 |
| Other study ID # | ASCT Sesques |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 30, 2017 |
| Est. completion date | July 31, 2018 |
| Verified date | September 2018 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT)
is a therapeutic option in follicular Lymphoma after first line treatment failure. The
clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and
therapeutic management in the rituximab era are not well known and may represent a difficult
challenge.
Patients and Methods: The investigators conducted a retrospective analysis of FL patients who
relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical
records were reviewed for clinical characteristics and treatment strategy at relapse. The
investigators aimed to identify prognostic factors related to patient's outcome.
| Status | Completed |
| Enrollment | 95 |
| Est. completion date | July 31, 2018 |
| Est. primary completion date | December 15, 2017 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - they were older than 18 years - presented FL at diagnosis (Grade 1, 2, or 3a). - received high-dose therapy (HDT) with ASCT from 2000 to 2014 Exclusion Criteria: 1. they had already been treated with a 1st ASCT, 2. had a previous history of histological transformation before ASCT 3. if they were rituximab naive prior to ASCT. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Lyon Sud, Hematology department | Pierre-Bénite |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival after relapse (SAR) post ASCT in follicular lymphoma | Factors that predicted SAR | Year 6 | |
| Secondary | Histological Transformation at relapse | A biopsy was performed at the first relapse or progression after ASCT. | Year 6 | |
| Secondary | treatment of relapse | Chemotherapy, radiotherapy… | Year 6 |