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

NCT04655261 | Terminated

• 1 other identifier: P20-486
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

Chronic Lymphocytic Leukemia (CLL); Venetoclax; Venclexta; Obinutuzumab; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Percentage of Participants Achieving Objective Response Rate (ORR)

  Up to 12 Months

• Time to First Response

  Up to approximately 36 Months

• Time to Best Response

  Up to approximately 36 Months

• Duration of Response (DoR)

  Up to approximately 36 Months

• Time to Next Treatment

  Up to approximately 36 Months

Study Arms (1)

Participants Treated With Venetoclax + Obinutuzumab

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with previously untreated chronic lymphocytic leukemia (CLL)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Moscow State budget healthcare /ID# 226058

Moscow, Moscow, 125284, Russia

Location

Regional Children's Clinical Hospital of Volgograd /ID# 238328

Volgograd, Volgograd Oblast, 400138, Russia

Location

Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127

Saint Petersburg, 191024, Russia

Location

Tula Regional Clinical Hospital /ID# 231128

Tula, 300053, Russia

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: December 12, 2020
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

RU (4)