B Cell Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL): Analysis of Real-life Data: "Snapshot" at 3 Years From the End of Ibrutinib ATU. A National Study of the FILO-LLC Group
| Verified date | May 2020 |
| Source | French Innovative Leukemia Organisation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
Assessment of the mutational profile of the residual clone and the distribution of lymphocyte
subpopulations at 3 years of treatment with ibrutinib
This project has an epidemiological part: to establish the percentage of patients, in a
real-life situation, still undergoing treatment 3 years after its initiation, as well as a
biological part: to determine the evolution of the clone and the prevalence of BTK mutations
and PLCg2 in the absence of clinical or biological criteria for scalability.
| Status | Completed |
| Enrollment | 198 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients included in the ATU (epidemiology) - under treatment at 3 years of ibrutinib - more than 18 years old Exclusion Criteria: - no ibrutinib treatment |
| Country | Name | City | State |
|---|---|---|---|
| France | FILO French Innovative Leukemia Organization | Tours | |
| France | Project manager | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| French Innovative Leukemia Organisation |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ibrutinib resistance | In the long term, this study will help to draft new recommendations from FILO-LLC concerning the detection of resistance and the management of patients. | under treatment at 3 years of ibrutinib |
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