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Chronic Lymphocytic Leukemia (CLL)FORTENCT03873857

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

An observational study of Chronic Lymphocytic Leukemia (CLL) and Cancer, run by AbbVie at 20 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia (CLL), Cancer
What is being tested?
Venetoclax
Type of treatment
Pill or oral medicine
How many people
71 participants
Where
20 sitesRussia
Study dates
25 Feb 2019to 12 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Russia20 sites

  • Krai Clinical Hospital /ID# 224952

    Barnaul, 656024

  • GBUZ Regional Cancer center /ID# 216871

    Irkutsk, 664032

  • Krai Clinical Hospital #1 /ID# 212367

    Khabarovsk, 680009

  • Kirov Regional Clinical Hospital /ID# 217579

    Kirov, 610027

  • Moscow State budget healthcare /ID# 212875

    Moscow, Moscow, 125284

  • Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 215830

    Moscow, Moscow Oblast, 129110

  • Policlinic #2 /ID# 214778

    Oryol, 302040

  • Clinical Medico-Sanitary Unit #1 /ID# 212364

    Perm, 614077

  • Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 212368

    Saint Petersburg, Sankt-Peterburg, 197101

  • Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 212372

    Saint Petersburg, 191024

  • Almazov National Medical Research Centre /ID# 212365

    Saint Petersburg, 197341

  • Oncology Dispensary #2 /ID# 215831

    Sochi, Krasnodarskiy Kray, 354057

  • Komi Republican Oncology Dispensary /ID# 212370

    Syktyvkar, 167904

  • City Clinical Hospital # 5 /ID# 212369

    Vladimir, 600031

  • Regional Children's Clinical Hospital of Volgograd /ID# 212366

    Volgograd, Volgograd Oblast, 400138

  • Regional Clinical Hospital of Vologda /ID# 212471

    Vologda, 160002

  • Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 212371

    Yakutsk, 677008

  • Central City Hospital #7 /ID# 212373

    Yekaterinburg, Sverdlovsk Oblast, 620137

  • Sverdlovsk Regional Clinical Hospital #1 /ID# 214777

    Yekaterinburg, 620102

  • Sakhalin Regional Clinical Hospital /ID# 222503

    Yuzhno-Sakhalinsk, 693004

Other trials in Russia

About this study

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)

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.

Being tested
Venetoclax
Keywords
Chronic Lymphocytic Leukemia (CLL), Cancer, Observational Study, Venetoclax, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Also called Venclexta, ABT-199

    tablet;oral

Study groups in NCT03873857
Study groupRoleWhat they receive
VenetoclaxParticipants 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.
Receives: Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 12 months after treatment initiation

Secondary outcomes (9)

  1. 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.

    Measured: Up to approximately 24 months after treatment initiation

  2. 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).

    Measured: Up to approximately 24 months

  3. 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).

    Measured: Up to approximately 24 months

  4. 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.

    Measured: Up to approximately 24 months

  5. 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.

    Measured: Up to approximately 24 months

  6. 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.

    Measured: Up to approximately 24 months

  7. 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.

    Measured: Up to approximately 24 months

  8. 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

    Measured: Up to approximately 24 months

  9. 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.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2019
  2. Study start25 Feb 2019
  3. Primary completion12 Sep 2022
  4. Study completion12 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03873857
Sponsor's protocol ID
P19-569
Acronym
FORTE
Status last verified
Aug 2023
First submitted
12 Mar 2019
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia (CLL) and Cancer, run by AbbVie at 20 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) 12 Months after Treatment Initiation (time frame: Up to approximately 12 months after treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03873857.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.

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