Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Outcomes of Unfit Patients With Chronic Lymphocytic Leukemia (CLL) Included in the Front-line GIMEMA LLC1114 Trial Who Discontinued Ibrutinib Due to Reasons Other Than Disease Progression: a Multicenter Retrospective/ Prospective Observational Study.
| NCT number | NCT06084923 |
| Other study ID # | CLL2523 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2024 |
| Est. completion date | May 2026 |
The goal of this observational study is to assess in the cohort of CLL patients enrolled in the front-line GIMEMA LLC1114 study who discontinued ibrutinib the time to subsequent treatment. The main question it aims to answer is: • The 12 and 24-month TTNT measured from the time of ibrutinib discontinuation due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up. Participants will be observed for the duration of the study.
| Status | Not yet recruiting |
| Enrollment | 73 |
| Est. completion date | May 2026 |
| Est. primary completion date | May 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients treated with ibrutinib included in the LLC1114 GIMEMA study who have discontinued ibrutinib after completing 78-months of treatment per protocol OR patients treated with ibrutinib included in the LLC1114 GIMEMA study who were treated for at least 12 months before discontinuing ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up and had achieved a response (CR or PR/PR-L) lasting at least 6 months before discontinuing ibrutinib - Informed consent, if applicable. Exclusion Criteria: - Patients with concomitant conditions that may interfere with an appropriate assessment of the TTNT in the physician opinion. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The 12 and 24-month Time To Next Treatment (TTNT) measured from the time of ibrutinib discontinuation due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up. | The 12 and 24-month time to the next treatment (TTNT) will be calculated in terms of the proportion of patients who requiring new treatment at 12 and 24 months. | 12 and 24 months |
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