A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation
FORTE
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)
1 other identifier
observational
71
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2019
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2019
CompletedFirst Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2022
CompletedSeptember 1, 2023
August 1, 2023
3.5 years
March 12, 2019
August 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) 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.
Up to approximately 12 months after treatment initiation
Secondary Outcomes (9)
Objective Response Rate (ORR) 24 Months after Treatment Initiation
Up to approximately 24 months after treatment initiation
Time to First Response to Treatment
Up to approximately 24 months
Time to Best Response to Treatment
Up to approximately 24 months
Duration of Response (DoR)
Up to approximately 24 months
Time To Next Treatment
Up to approximately 24 months
- +4 more secondary outcomes
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients with relapsed or refractory CLL in a real-world clinical practice setting.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (20)
Oncology Dispensary #2 /ID# 215831
Sochi, Krasnodarskiy Kray, 354057, Russia
Moscow State budget healthcare /ID# 212875
Moscow, Moscow, 125284, Russia
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 215830
Moscow, Moscow Oblast, 129110, Russia
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 212368
Saint Petersburg, Sankt-Peterburg, 197101, Russia
Central City Hospital #7 /ID# 212373
Yekaterinburg, Sverdlovsk Oblast, 620137, Russia
Regional Children's Clinical Hospital of Volgograd /ID# 212366
Volgograd, Volgograd Oblast, 400138, Russia
Krai Clinical Hospital /ID# 224952
Barnaul, 656024, Russia
GBUZ Regional Cancer center /ID# 216871
Irkutsk, 664032, Russia
Krai Clinical Hospital #1 /ID# 212367
Khabarovsk, 680009, Russia
Kirov Regional Clinical Hospital /ID# 217579
Kirov, 610027, Russia
Policlinic #2 /ID# 214778
Oryol, 302040, Russia
Clinical Medico-Sanitary Unit #1 /ID# 212364
Perm, 614077, Russia
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 212372
Saint Petersburg, 191024, Russia
Almazov National Medical Research Centre /ID# 212365
Saint Petersburg, 197341, Russia
Komi Republican Oncology Dispensary /ID# 212370
Syktyvkar, 167904, Russia
City Clinical Hospital # 5 /ID# 212369
Vladimir, 600031, Russia
Regional Clinical Hospital of Vologda /ID# 212471
Vologda, 160002, Russia
Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 212371
Yakutsk, 677008, Russia
Sverdlovsk Regional Clinical Hospital #1 /ID# 214777
Yekaterinburg, 620102, Russia
Sakhalin Regional Clinical Hospital /ID# 222503
Yuzhno-Sakhalinsk, 693004, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 14, 2019
Study Start
February 25, 2019
Primary Completion
September 12, 2022
Study Completion
September 12, 2022
Last Updated
September 1, 2023
Record last verified: 2023-08