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

Sponsor

AbbVie (Industry)

Overall Status

Terminated

CT.gov ID

NCT04655261

Collaborator

(none)

Enrollment

Locations

10.9

Actual Duration (Months)

1.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia (CLL)

Study Design

Study Type:

Observational

Actual Enrollment :

5 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Dec 12, 2020

Actual Primary Completion Date :

Nov 9, 2021

Actual Study Completion Date :

Nov 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Participants Treated With Venetoclax + Obinutuzumab Participants will receive venetoclax (Venclexta) in combination with Obinutuzumab according to local label.

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Overall Response Rate (ORR) Best Response [Up to approximately 36 Months]
ORR is defined as complete remission (CR) + complete remission with incomplete bone marrow recovery (CRi) + partial remission (PR) + nodular partial remission (nPR).

Secondary Outcome Measures

Percentage of Participants Achieving Objective Response Rate (ORR) [Up to 12 Months]
ORR is defined as CR + CRi + PR + nPR.
Time to First Response [Up to approximately 36 Months]
Time to first response is defined as number of days from first venetoclax intake to first response.
Time to Best Response [Up to approximately 36 Months]
Time to best response is defined as number of days from first venetoclax intake to best response (CR, CRi, PR, nPR).
Duration of Response (DoR) [Up to approximately 36 Months]
Duration of Response (DoR) is defined as number of days from first response to disease progression or death from any cause, whichever comes first.
Time to Next Treatment [Up to approximately 36 Months]
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.
Minimal Residual Disease (MRD) [Up to 36 Months]
Percentage of participants achieving MRD (CLL < 10000 leucocytes) in the bone marrow, peripheral blood, either and both will be assessed.
Overall Survival (OS) [Up to 36 Months]
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.
Progression-Free Survival (PFS) [Up to 36 Months]
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.
Number of Participants With Adverse Events (AEs) [Up to approximately 36 Months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moscow State budget healthcare /ID# 226058	Moscow	Moskva	Russian Federation	125284
2	Regional Children's Clinical Hospital of Volgograd /ID# 238328	Volgograd	Volgogradskaya Oblast	Russian Federation	400138
3	Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127	Sankt-Peterburg		Russian Federation	191024
4	Tula Regional Clinical Hospital /ID# 231128	Tula		Russian Federation	300053