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NCT Number: 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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia (CLL) Cancer Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oncology Dispensary #2 /ID# 215831, Sochi, Krasnodarskiy Kray, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venetoclax

Drug

tablet;oral

Other names: Venclexta, ABT-199

Primary outcomes

  1. Objective Response Rate (ORR) 12 Months after Treatment Initiation

    Time frame: 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 outcomes

  1. Objective Response Rate (ORR) 24 Months after Treatment Initiation

    Time frame: 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.

  2. Time to First Response to Treatment

    Time frame: 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).

  3. Time to Best Response to Treatment

    Time frame: 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).

  4. Duration of Response (DoR)

    Time frame: 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.

  5. Time To Next Treatment

    Time frame: 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.

  6. Percentage of Patients with Undetectable Minimal Residual Disease (MRD)

    Time frame: 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.

  7. Overall Survival (OS) Rate

    Time frame: 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.

  8. Progression-free Survival (PFS)

    Time frame: 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

  9. Change from Baseline in RAND Short Form (SF)-36 Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: FORTE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2019
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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