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Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

NCT02475681 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 535

Last updated 2025-08-27

Study results available
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Summary

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)

Conditions

Interventions

DRUG

Acalabrutinib

DRUG

Obinutuzumab

DRUG

Chlorambucil

Sponsors & Collaborators

  • Acerta Pharma BV

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-26
Primary Completion
2019-02-08
Completion
2025-09-30

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • New Zealand
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475681 on ClinicalTrials.gov