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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

— FIRST  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04655261
• Other study ID #: P20-486
• Status: Terminated
• Start date: December 12, 2020
• Est. completion date: November 9, 2021

Study information

• Verified date: October 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 9, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Russian Federation	Moscow State budget healthcare /ID# 226058	Moscow	Moskva
Russian Federation	Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127	Sankt-Peterburg
Russian Federation	Tula Regional Clinical Hospital /ID# 231128	Tula
Russian Federation	Regional Children's Clinical Hospital of Volgograd /ID# 238328	Volgograd	Volgogradskaya Oblast

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Achieving Objective Response Rate (ORR)	ORR is defined as CR + CRi + PR + nPR.	Up to 12 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis