CLL Therapy Approaches in Russia

Chronic Lymphocytic Leukemia Clinical Trial

— CLL registry  

Official title:

Observational Retrospective-Prospective Study on CLL Therapy Approaches in Russia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140369
• Other study ID #: D8220R00038
• Status: Recruiting
• Start date: October 29, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Russian Federation	Research site	Belgorod
Russian Federation	Research site	Bryansk
Russian Federation	Research site	Buriatia
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research site	Chita
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Irkutsk
Russian Federation	Research site	Kaliningrad
Russian Federation	Research Site	Kaluga
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Kirov
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Kurgan
Russian Federation	Research site	Mahachkala
Russian Federation	Research Site	Moscow
Russian Federation	Research site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research site	Omsk
Russian Federation	Research site	Orenburg
Russian Federation	Research Site	Petrozavodsk
Russian Federation	Research Site	Rostov on Don
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Syktyvkar
Russian Federation	Research site	Tver
Russian Federation	Research Site	Ufa
Russian Federation	Research site	Ulan-Ude
Russian Federation	Research site	Vladimir
Russian Federation	Research Site	Volgograd
Russian Federation	Research site	Vologda
Russian Federation	Research Site	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex		Baseline
Primary	Date of diagnosis for CLL/SLL		Baseline
Primary	Comorbidities		Up to 2 years
Primary	ECOG status (0-1/=2)		Up to 2 years
Primary	Rai staging (0-IV)		Up to 2 years
Primary	Cytogenetic tests	TP53 gene mutation status; IGHV gene mutation status; complex karyotype; del13q status	Up to 2 years