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Chronic Lymphocytic Leukemia (CLL)FIRSTNCT04655261

Study of Oral Venetoclax Tablets in Combination With Intravenous Obinutuzumab Injection to Assess Achievement of Best Response in Adult Participants With Chronic Lymphocytic Leukemia

An observational study of Chronic Lymphocytic Leukemia (CLL), run by AbbVie at 4 sites in Russia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Chronic Lymphoid Leukemia (CLL) is the most common type of leukemia (cancer of blood cells) in adults affecting men more so than women. The main objective of this study is to assess the how effective venetoclax (Venclexta) in combination with Obinutuzumab is in treating Chronic Lymphocytic Leukemia (CLL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia (CLL)
How many people
5 participants
Where
4 sitesRussia
Study dates
12 Dec 2020to 9 Nov 2021
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: Adult participants with previously untreated chronic lymphocytic leukemia (CLL)

Who may be able to join

  • Confirmed diagnosis of previously untreated Chronic Lymphocytic Leukemia (CLL).
  • Participant for whom the physician has decided to initiate CLL treatment with Venetoclax combo therapy with Obinutuzumab, according to approved local label up to 4 weeks (28 days) after Obinutuzumab treatment initiation.

Who cannot join

  • Contraindications to Venclexta (Venetoclax) as listed on the approved local label in Russian Federation.
  • Creatinine Clearance < 30 milliLitres/minute.
  • Richter syndrome or Transformation of CLL to aggressive non-Hodgkin lymphoma.
  • Participating in a clinical trial with an investigative drug for CLL.

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

  • Moscow State budget healthcare /ID# 226058

    Moscow, Moscow, 125284

  • Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127

    Saint Petersburg, 191024

  • Tula Regional Clinical Hospital /ID# 231128

    Tula, 300053

  • Regional Children's Clinical Hospital of Volgograd /ID# 238328

    Volgograd, Volgograd Oblast, 400138

Other trials in Russia

About this study

Official title: Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Combination With Obinutuzumab in Population of Previously Untreated Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FIRST)

Chronic Lymphoid Leukemia (CLL) is the most common type of leukemia (cancer of blood cells) in adults affecting men more so than women. The main objective of this study is to assess the how effective venetoclax (Venclexta) in combination with Obinutuzumab is in treating Chronic Lymphocytic Leukemia (CLL). Effectiveness is assessed by achievement of best response.

Venetoclax is an approved drug developed for the treatment of CLL. Approximately 50 adult participants with previously untreated CLL will be enrolled in approximately 10 to 15 sites in Russian Federation.

Read more

Participants will receive oral venetoclax tablets in combination with intravenous (IV) Obinutuzumab as prescribed by the physician prior to enrolling in this study in accordance to the local practice and label.

There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Keywords
Chronic Lymphocytic Leukemia (CLL), Venetoclax, Venclexta, Obinutuzumab, Cancer
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.

Study groups in NCT04655261
Study groupRoleWhat they receive
Participants Treated With Venetoclax + ObinutuzumabParticipants will receive venetoclax (Venclexta) in combination with Obinutuzumab according to local label.

What is being measured

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

  1. Percentage of Participants Achieving Overall Response Rate (ORR) Best Response

    ORR is defined as complete remission (CR) + complete remission with incomplete bone marrow recovery (CRi) + partial remission (PR) + nodular partial remission (nPR).

    Measured: Up to approximately 36 Months

Secondary outcomes (9)

  1. Percentage of Participants Achieving Objective Response Rate (ORR)

    ORR is defined as CR + CRi + PR + nPR.

    Measured: Up to 12 Months

  2. Time to First Response

    Time to first response is defined as number of days from first venetoclax intake to first response.

    Measured: Up to approximately 36 Months

  3. Time to Best Response

    Time to best response is defined as number of days from first venetoclax intake to best response (CR, CRi, PR, nPR).

    Measured: Up to approximately 36 Months

  4. Duration of Response (DoR)

    Duration of Response (DoR) is defined as number of days from first response to disease progression or death from any cause, whichever comes first.

    Measured: Up to approximately 36 Months

  5. Time to Next Treatment

    Time to next treatment is defined as number of days from first venetoclax intake to first intake of next treatment including death from any cause.

    Measured: Up to approximately 36 Months

  6. Minimal Residual Disease (MRD)

    Percentage of participants achieving MRD (CLL < 10000 leucocytes) in the bone marrow, peripheral blood, either and both will be assessed.

    Measured: Up to 36 Months

  7. Overall Survival (OS)

    OS is defined as the number of days from the date of first dose to the date of the observational period end or death for all dosed participants.

    Measured: Up to 36 Months

  8. Progression-Free Survival (PFS)

    PFS is defined as the interval (in days) between the first treatment day to the first sign of disease progression or death from any cause.

    Measured: Up to 36 Months

  9. Number of Participants With Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to approximately 36 Months

Timeline

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

  1. First posted7 Dec 2020
  2. Study start12 Dec 2020
  3. Primary completion9 Nov 2021
  4. Study completion9 Nov 2021

Why it stopped: Lack of Recruitment

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
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04655261
Sponsor's protocol ID
P20-486
Acronym
FIRST
Status last verified
Oct 2022
First submitted
30 Nov 2020
Last updated
26 Oct 2022
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), run by AbbVie at 4 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 was stopped early (reason given: Lack of Recruitment). Results are not available in the source record.

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?

Percentage of Participants Achieving Overall Response Rate (ORR) Best Response (time frame: Up to approximately 36 Months). 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 NCT04655261.

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 26 Oct 2022.

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