Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 11:04 AM
Study NCT ID:
NCT05140369
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-25
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLL Therapy Approaches in Russia
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Observational Retrospective-Prospective Study on CLL Therapy Approaches in Russia.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLL registry
Brief Summary:
This is going to be a non-interventional study (NIS). Assessment of variables will be carried out using data on patient's treatment in real-life clinical setting. Patients should be enrolled into study after evaluation of eligibility criteria by the investigator. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
Evaluation of efficacy and safety of any approaches used for CLL/SLL treatment is not the primary objective of this study, though there is no treatment of interest. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance).
It is planned to enroll approximately 6000 patients (suggested number of patients on WW\~1000 pts, 1L\~2750 pts, RR\~2250 pts)
During the course of study's prospective part, it is planned to carry out at approximately 5 visits:
(if unscheduled visit performed - the information should be filled on nearest visit).
* Baseline visit: ICF signing, initial patient's data input will be done retrospectively, for patients who are already monitored by investigational site.
* Interim Visits (CRF will be filled every 6 months for therapy receiving patients and every 12 months for WW patients; if a patient transitions from WW to therapy, his/her CRF will be filled every 6 months; all patient's visits should be planned according routine practice and investigator's judgement on individual basis).
* Final visit (data collection on 24 months after enrollment): patient's data input will be done for previously enrolled patients (data update)
Evaluation of efficacy and safety of any approaches used for CLL/SLL treatment is not the primary objective of this study, though there is no treatment of interest. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance).
It is planned to enroll approximately 6000 patients (suggested number of patients on WW\~1000 pts, 1L\~2750 pts, RR\~2250 pts)
During the course of study's prospective part, it is planned to carry out at approximately 5 visits:
(if unscheduled visit performed - the information should be filled on nearest visit).
* Baseline visit: ICF signing, initial patient's data input will be done retrospectively, for patients who are already monitored by investigational site.
* Interim Visits (CRF will be filled every 6 months for therapy receiving patients and every 12 months for WW patients; if a patient transitions from WW to therapy, his/her CRF will be filled every 6 months; all patient's visits should be planned according routine practice and investigator's judgement on individual basis).
* Final visit (data collection on 24 months after enrollment): patient's data input will be done for previously enrolled patients (data update)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: