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)

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Chronic Lymphocytic Leukemia (CLL)
• Intervention / Treatment: Drug: Venetoclax

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Russian Federation
  • Barnaul, Russian Federation, 656024
    • Krai Clinical Hospital /ID# 224952
  • Irkutsk, Russian Federation, 664032
    • GBUZ Regional Cancer center /ID# 216871
  • Khabarovsk, Russian Federation, 680009
    • Krai Clinical Hospital #1 /ID# 212367
  • Kirov, Russian Federation, 610027
    • Kirov Regional Clinical Hospital /ID# 217579
  • Oryol, Russian Federation, 302040
    • Policlinic #2 /ID# 214778
  • Perm, Russian Federation, 614077
    • Clinical Medico-Sanitary Unit #1 /ID# 212364
  • Sankt-Peterburg, Russian Federation, 191024
    • Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 212372
  • Sankt-Peterburg, Russian Federation, 197341
    • Almazov National Medical Research Centre /ID# 212365
  • Syktyvkar, Russian Federation, 167904
    • Komi Republican Oncology Dispensary /ID# 212370
  • Vladimir, Russian Federation, 600031
    • City Clinical Hospital # 5 /ID# 212369
  • Vologda, Russian Federation, 160002
    • Regional Clinical Hospital of Vologda /ID# 212471
  • Yakutsk, Russian Federation, 677008
    • Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 212371
  • Yekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital #1 /ID# 214777
  • Yuzhno-Sakhalinsk, Russian Federation, 693004
    • Sakhalin Regional Clinical Hospital /ID# 222503
  • Krasnodarskiy Kray
    • Sochi, Krasnodarskiy Kray, Russian Federation, 354057
      • Oncology Dispensary #2 /ID# 215831
  • Moskovskaya Oblast
    • Moscow, Moskovskaya Oblast, Russian Federation, 129110
      • Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 215830
  • Moskva
    • Moscow, Moskva, Russian Federation, 125284
      • Moscow State budget healthcare /ID# 212875
  • Sankt-Peterburg
    • St. Petersburg, Sankt-Peterburg, Russian Federation, 197101
      • Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 212368
  • Sverdlovskaya Oblast
    • Yekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620137
      • Central City Hospital #7 /ID# 212373
  • Volgogradskaya Oblast
    • Volgograd, Volgogradskaya Oblast, Russian Federation, 400138
      • Regional Children's Clinical Hospital of Volgograd /ID# 212366

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed or refractory CLL in a real-world clinical practice setting.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: Venetoclax; tablet;oral; Other Names: Venclexta; ABT-199

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): September 12, 2022
• Study Completion (Actual): September 12, 2022

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Observational Study; Venetoclax; Chronic Lymphocytic Leukemia (CLL); Relapsed Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia, B-Cell; Chronic Disease; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Antineoplastic Agents; Venetoclax
• Other Study ID Numbers: P19-569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No