Clinical trial NCT04655261: Study of Oral Venetoclax Tablets in Combination With Intravenous Obinutuzumab Injection to Assess Achievement of Best Response in Adult Participants With Chronic Lymphocytic Leukemia
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: Chronic Lymphocytic Leukemia (CLL)
Venetoclax
Venclexta
Obinutuzumab
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with previously untreated chronic lymphocytic leukemia (CLL)

Brief 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). 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Overall Response Rate (ORR) Best Response
timeFrame: Up to approximately 36 Months
Secondary outcomes:
measure: Percentage of Participants Achieving Objective Response Rate (ORR)
timeFrame: Up to 12 Months
measure: Time to First Response
timeFrame: Up to approximately 36 Months
measure: Time to Best Response
timeFrame: Up to approximately 36 Months
measure: Duration of Response (DoR)
timeFrame: Up to approximately 36 Months
measure: Time to Next Treatment
timeFrame: Up to approximately 36 Months
measure: Minimal Residual Disease (MRD)
timeFrame: Up to 36 Months
measure: Overall Survival (OS)
timeFrame: Up to 36 Months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 36 Months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 36 Months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow State budget healthcare /ID# 226058
state: Moskva
city: Volgograd
country: Russian Federation
facility: Regional Children's Clinical Hospital of Volgograd /ID# 238328
state: Volgogradskaya Oblast
city: Sankt-Peterburg
country: Russian Federation
facility: Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospital /ID# 231128
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: