Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is an observational, multicenter, retrospective and prospective study aimed at analyzing in the cohort of CLL patients enrolled in the front-line GIMEMA LLC1114 study the time to next treatment in patients who discontinued ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who discontinued ibrutinib | CLL patients enrolled in the front-line GIMEMA LLC1114 study twho discontinued ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Patients will be observed after ibrutinib discontinuation and data on ibrutinib discontinuation, reatreatment and outcome will be collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Patients with concomitant conditions that may interfere with an appropriate assessment of the TTNT in the physician opinion.
Not provided
Not provided
Not provided
CLL patients enrolled in the front-line GIMEMA LLC1114 study who discontinued ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola Fazi | Contact | 0670390528 | p.fazi@gimema.it | |
| Enrico Crea | Contact | 0670390514 | e.crea@gimema.it |
| Name | Affiliation | Role |
|---|---|---|
| Francresca Romana Mauro | University of Roma La Sapienza | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided