Clinical trial NCT05140369: CLL Therapy Approaches in Russia
Official title: Observational Retrospective-Prospective Study on CLL Therapy Approaches in Russia.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic lymphocytic leukemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It is expected to recruit approximately 6000 patients with CLL/SLL regardless of treatment stage and line.

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)


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Ability and willing to sign the ICF
* Diagnosed CLL/SLL (including watch and wait stage of disease) according to Russian clinical guides

Exclusion Criteria:

* Patients without CLL/SLL diagnosis
* Age \<18 years
* Patients who refused/did not sign the ICF

Primary outcomes:
measure: Sex
timeFrame: Baseline
measure: Date of diagnosis for CLL/SLL
timeFrame: Baseline
measure: Comorbidities
timeFrame: Up to 2 years
measure: ECOG status (0-1/≥2)
timeFrame: Up to 2 years
measure: Rai staging (0-IV)
timeFrame: Up to 2 years
measure: Cytogenetic tests
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Belgorod
country: Russian Federation
facility: Research site
city: Bryansk
country: Russian Federation
facility: Research site
city: Buriatia
country: Russian Federation
facility: Research site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Chita
country: Russian Federation
facility: Research site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kaliningrad
country: Russian Federation
facility: Research site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Kurgan
country: Russian Federation
facility: Research Site
city: Mahachkala
country: Russian Federation
facility: Research site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research site
city: Orenburg
country: Russian Federation
facility: Research site
city: Perm
country: Russian Federation
facility: Research site
city: Petropavlovsk-Kamchtskiy
country: Russian Federation
facility: Research site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Rostov on Don
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research site
city: Samara
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Syktyvkar
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research site
city: Ufa
country: Russian Federation
facility: Research Site
city: Ulan-Ude
country: Russian Federation
facility: Research site
city: Vladimir
country: Russian Federation
facility: Research site
city: Vladivostok
country: Russian Federation
facility: Research site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Vologda
country: Russian Federation
facility: Research site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
References: