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)

AbbVie

Status: Terminated

Conditions: Chronic Lymphocytic Leukemia (CLL)

Study type: Observational

Funder types: Industry

Identifiers

NCT04655261

P20-486

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

5 participants in 1 patient group

Participants Treated With Venetoclax + Obinutuzumab

Description:

Participants will receive venetoclax (Venclexta) in combination with Obinutuzumab according to local label.