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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Lymphocytic Leukemia (CLL)

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Russian Federation
  • Sankt-Peterburg, Russian Federation, 191024
    • Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127
  • Tula, Russian Federation, 300053
    • Tula Regional Clinical Hospital /ID# 231128
  • Moskva
    • Moscow, Moskva, Russian Federation, 125284
      • Moscow State budget healthcare /ID# 226058
  • Volgogradskaya Oblast
    • Volgograd, Volgogradskaya Oblast, Russian Federation, 400138
      • Regional Children's Clinical Hospital of Volgograd /ID# 238328

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with previously untreated chronic lymphocytic leukemia (CLL)

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants Treated With Venetoclax + Obinutuzumab; Participants will receive venetoclax (Venclexta) in combination with Obinutuzumab according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to approximately 36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Objective Response Rate (ORR)	ORR is defined as CR + CRi + PR + nPR.	Up to 12 Months
Time to First Response	Time to first response is defined as number of days from first venetoclax intake to first response.	Up to approximately 36 Months
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).	Up to approximately 36 Months
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.	Up to approximately 36 Months
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.	Up to approximately 36 Months
Minimal Residual Disease (MRD)	Percentage of participants achieving MRD (CLL < 10000 leucocytes) in the bone marrow, peripheral blood, either and both will be assessed.	Up to 36 Months
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.	Up to 36 Months
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.	Up to 36 Months
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.	Up to approximately 36 Months

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Actual): November 9, 2021
• Study Completion (Actual): November 9, 2021

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Venetoclax; Chronic Lymphocytic Leukemia (CLL); Venclexta; Obinutuzumab
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: P20-486

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