A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy

• Status: Active, not recruiting
• Trial end date: 2023-07-19
• Target enrollment: 0
• Participant gender: All

Summary

A study in previously untreated Chronic Lymphocytic Leukemia participants to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Bendamustine Hydrochloride; Obinutuzumab; Venetoclax

Criteria

Inclusion Criteria:

• Adequate hematology, kidney and liver function as described in the protocol.

• Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria.

• Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.

• CLL requires treatment according to the IWCLL criteria.

• Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] >= 25 × 10^9/L) OR High tumor burden (any LN >= 10 cm OR ALC >= 25 × 10^9/L and LN >= 5 cm).

Exclusion Criteria:

• Presence of 17p deletion at Screening.

• Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma).

• Prolymphocytic leukemia.