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NCT02475681 · ClinicalTrials.gov record · last posted 2026-08-25

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

Study acronym: ElevateTN
StatusActive, Not Recruiting
PhasePhase 3
Started2015-06-26
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria. 2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)

Protocol amendment history 1 change detected by DataLookout

2026-08-26
minor
Completion pushed: 2025-09-30 → 2026-09-15
Trial Details
NCT Number NCT02475681
Lead Sponsor Acerta Pharma BV
Conditions Chronic Lymphocytic Leukemia
Enrollment 535 participants
Start Date 2015-06-26
Primary Completion 2019-02-08 (estimated)
Study Completion 2026-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-25