A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation
- Registration Number
- NCT03873857
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Venetoclax Venetoclax Participants in this observational study will receive treatment with venetoclax for up to 24 months for treatment of relapsed or refractory CLL. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 12 Months after Treatment Initiation Up to approximately 12 months after treatment initiation ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) 24 Months after Treatment Initiation Up to approximately 24 months after treatment initiation ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment.
Time To Next Treatment Up to approximately 24 months The time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation.
Overall Survival (OS) Rate Up to approximately 24 months OS is defined as number of days from the date of first dose to the date of the observational period end or death for all dosed patients.
Percentage of Patients with Undetectable Minimal Residual Disease (MRD) Up to approximately 24 months Patients will be defined as having a clinical remission in the absence of MRD when they have blood or marrow with less than one CLL cell per 10000 leucocytes.
Progression-free Survival (PFS) Up to approximately 24 months Progression-free survival is defined as the interval between the first treatment day to the first sign of disease progression or death from any cause
Time to First Response to Treatment Up to approximately 24 months The time to response to treatment is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented a response (CR, CRi, nPR, and PR).
Time to Best Response to Treatment Up to approximately 24 months The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the best response documented (CR, CRi, nPR, and PR).
Duration of Response (DoR) Up to approximately 24 months DoR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the date of disease progression or death from any cause, whichever comes first.
Change from Baseline in RAND Short Form (SF)-36 Questionnaire Up to approximately 24 months Patient quality of life was measured by the RAND-36 health-related quality of life (HRQoL) survey instrument. This questionnaire is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Trial Locations
- Locations (20)
Clinical Medico-Sanitary Unit #1 /ID# 212364
🇷🇺Perm, Russian Federation
Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 212371
🇷🇺Yakutsk, Russian Federation
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 212372
🇷🇺Sankt-Peterburg, Russian Federation
Almazov National Medical Research Centre /ID# 212365
🇷🇺Sankt-Peterburg, Russian Federation
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 215830
🇷🇺Moscow, Moskovskaya Oblast, Russian Federation
Krai Clinical Hospital #1 /ID# 212367
🇷🇺Khabarovsk, Russian Federation
Komi Republican Oncology Dispensary /ID# 212370
🇷🇺Syktyvkar, Russian Federation
City Clinical Hospital # 5 /ID# 212369
🇷🇺Vladimir, Russian Federation
Sakhalin Regional Clinical Hospital /ID# 222503
🇷🇺Yuzhno-Sakhalinsk, Russian Federation
Oncology Dispensary #2 /ID# 215831
🇷🇺Sochi, Krasnodarskiy Kray, Russian Federation
Central City Hospital #7 /ID# 212373
🇷🇺Yekaterinburg, Sverdlovskaya Oblast, Russian Federation
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 212368
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
Moscow State budget healthcare /ID# 212875
🇷🇺Moscow, Moskva, Russian Federation
Regional Children's Clinical Hospital of Volgograd /ID# 212366
🇷🇺Volgograd, Volgogradskaya Oblast, Russian Federation
Krai Clinical Hospital /ID# 224952
🇷🇺Barnaul, Russian Federation
GBUZ Regional Cancer center /ID# 216871
🇷🇺Irkutsk, Russian Federation
Kirov Regional Clinical Hospital /ID# 217579
🇷🇺Kirov, Russian Federation
Policlinic #2 /ID# 214778
🇷🇺Oryol, Russian Federation
Regional Clinical Hospital of Vologda /ID# 212471
🇷🇺Vologda, Russian Federation
Sverdlovsk Regional Clinical Hospital #1 /ID# 214777
🇷🇺Yekaterinburg, Russian Federation