A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation

Cancer Clinical Trial

— FORTE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873857
• Other study ID #: P19-569
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: September 12, 2022

Study information

• Verified date: August 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 12, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Venetoclax
tablet;oral

Locations

Country	Name	City	State
Russian Federation	Krai Clinical Hospital /ID# 224952	Barnaul
Russian Federation	GBUZ Regional Cancer center /ID# 216871	Irkutsk
Russian Federation	Krai Clinical Hospital #1 /ID# 212367	Khabarovsk
Russian Federation	Kirov Regional Clinical Hospital /ID# 217579	Kirov
Russian Federation	Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 215830	Moscow	Moskovskaya Oblast
Russian Federation	Moscow State budget healthcare /ID# 212875	Moscow	Moskva
Russian Federation	Policlinic #2 /ID# 214778	Oryol
Russian Federation	Clinical Medico-Sanitary Unit #1 /ID# 212364	Perm
Russian Federation	Almazov National Medical Research Centre /ID# 212365	Sankt-Peterburg
Russian Federation	Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 212372	Sankt-Peterburg
Russian Federation	Oncology Dispensary #2 /ID# 215831	Sochi	Krasnodarskiy Kray
Russian Federation	Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 212368	St. Petersburg	Sankt-Peterburg
Russian Federation	Komi Republican Oncology Dispensary /ID# 212370	Syktyvkar
Russian Federation	City Clinical Hospital # 5 /ID# 212369	Vladimir
Russian Federation	Regional Children's Clinical Hospital of Volgograd /ID# 212366	Volgograd	Volgogradskaya Oblast
Russian Federation	Regional Clinical Hospital of Vologda /ID# 212471	Vologda
Russian Federation	Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 212371	Yakutsk
Russian Federation	Central City Hospital #7 /ID# 212373	Yekaterinburg	Sverdlovskaya Oblast
Russian Federation	Sverdlovsk Regional Clinical Hospital #1 /ID# 214777	Yekaterinburg
Russian Federation	Sakhalin Regional Clinical Hospital /ID# 222503	Yuzhno-Sakhalinsk

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Response Rate (ORR) 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.	Up to approximately 24 months after treatment initiation
Secondary	Time to First Response to Treatment	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).	Up to approximately 24 months
Secondary	Time to Best Response to Treatment	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).	Up to approximately 24 months
Secondary	Duration of Response (DoR)	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.	Up to approximately 24 months
Secondary	Time To Next Treatment	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.	Up to approximately 24 months
Secondary	Percentage of Patients with Undetectable Minimal Residual Disease (MRD)	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.	Up to approximately 24 months
Secondary	Overall Survival (OS) Rate	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.	Up to approximately 24 months
Secondary	Progression-free Survival (PFS)	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	Up to approximately 24 months
Secondary	Change from Baseline in RAND Short Form (SF)-36 Questionnaire	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.	Up to approximately 24 months

External Links

•   clinical study report synopsis