A Study to Compare the Efficacy and Safety of a Combined Regimen of Obinutuzumab and Venetoclax (GDC-0199/ABT-199) Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients with CLL and Coexisting Medical Conditions

Phase 1

• Conditions: Chronic Lymphocytic Leukemia (CLL); MedDRA version: 21.0Level: LLTClassification code: 10008976Term: Chronic lymphocytic leukemia Class: 10029104; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2023-504034-22-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-26
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, CLL requiring treatment according to IWCLL criteria, Total Cumulative Illness Rating Scale (CIRS) score > 6 or creatinine clearance (CrCl) < 70 mL/min, Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL, Adequate liver function, Life expectancy > 6 months

Exclusion Criteria

Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter’s transformation or pro-lymphocytic leukemia), Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML), An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system, Patients with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia, Hypersensitivity to chlorambucil, obinutuzumab, or Venetoclax or to any of the excipients, Patients with active infections requiring intravenous (IV) treatment (grade 3 or 4) within the last two months prior to enrollment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified