Clinical trial NCT03873857: A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation
Official title: Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Population of Relapse or Refractory Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FORTE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia (CLL)
Cancer
Keywords: Chronic Lymphocytic Leukemia (CLL)
Cancer
Observational Study
Venetoclax
Relapsed Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed or refractory CLL in a real-world clinical practice setting.

Brief summary: This study seeks to assess the effectiveness and safety of venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) in a real-world setting across clinical practice in the Russian Federation.


Eligibility criteria: Inclusion Criteria:

* Has a confirmed diagnosis of relapsed or refractory CLL.
* Patient for whom the physician has decided to initiate CLL treatment with venetoclax (mono and combo therapy), or up to 4 weeks after venetoclax treatment initiation
* Patient voluntarily agrees to participate in this study and signs informed consent form

Exclusion Criteria:

* Has contraindications to venetoclax as listed on the approved local label in Russian Federation.
* Has Richter syndrome
* Participated in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation

Primary outcomes:
measure: Objective Response Rate (ORR) 12 Months after Treatment Initiation
timeFrame: Up to approximately 12 months after treatment initiation
Secondary outcomes:
measure: Objective Response Rate (ORR) 24 Months after Treatment Initiation
timeFrame: Up to approximately 24 months after treatment initiation
measure: Time to First Response to Treatment
timeFrame: Up to approximately 24 months
measure: Time to Best Response to Treatment
timeFrame: Up to approximately 24 months
measure: Duration of Response (DoR)
timeFrame: Up to approximately 24 months
measure: Time To Next Treatment
timeFrame: Up to approximately 24 months
measure: Percentage of Patients with Undetectable Minimal Residual Disease (MRD)
timeFrame: Up to approximately 24 months
measure: Overall Survival (OS) Rate
timeFrame: Up to approximately 24 months
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 24 months
measure: Change from Baseline in RAND Short Form (SF)-36 Questionnaire
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Sochi
country: Russian Federation
facility: Oncology Dispensary #2 /ID# 215831
state: Krasnodarskiy Kray
city: Moscow
country: Russian Federation
facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 215830
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Moscow State budget healthcare /ID# 212875
state: Moskva
city: St. Petersburg
country: Russian Federation
facility: Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 212368
state: Sankt-Peterburg
city: Yekaterinburg
country: Russian Federation
facility: Central City Hospital #7 /ID# 212373
state: Sverdlovskaya Oblast
city: Volgograd
country: Russian Federation
facility: Regional Children's Clinical Hospital of Volgograd /ID# 212366
state: Volgogradskaya Oblast
city: Barnaul
country: Russian Federation
facility: Krai Clinical Hospital /ID# 224952
city: Irkutsk
country: Russian Federation
facility: GBUZ Regional Cancer center /ID# 216871
city: Khabarovsk
country: Russian Federation
facility: Krai Clinical Hospital #1 /ID# 212367
city: Kirov
country: Russian Federation
facility: Kirov Regional Clinical Hospital /ID# 217579
city: Oryol
country: Russian Federation
facility: Policlinic #2 /ID# 214778
city: Perm
country: Russian Federation
facility: Clinical Medico-Sanitary Unit #1 /ID# 212364
city: Sankt-Peterburg
country: Russian Federation
facility: Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 212372
city: Sankt-Peterburg
country: Russian Federation
facility: Almazov National Medical Research Centre /ID# 212365
city: Syktyvkar
country: Russian Federation
facility: Komi Republican Oncology Dispensary /ID# 212370
city: Vladimir
country: Russian Federation
facility: City Clinical Hospital # 5 /ID# 212369
city: Vologda
country: Russian Federation
facility: Regional Clinical Hospital of Vologda /ID# 212471
city: Yakutsk
country: Russian Federation
facility: Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 212371
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1 /ID# 214777
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Sakhalin Regional Clinical Hospital /ID# 222503
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: