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NCT02475681 · ClinicalTrials.gov registry record · Phase 3

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

A Phase 3 study of Chronic Lymphocytic Leukemia, sponsored by Acerta Pharma.

Active
Registry status
Phase 3
Development phase
535
Enrollment target
20
Study locations

NCT02475681: Active Phase 3 study of Chronic Lymphocytic Leukemia, sponsored by Acerta Pharma.

NCT02475681 is a Phase 3 study of Chronic Lymphocytic Leukemia that is active but no longer recruiting, run by Acerta Pharma. The registered enrollment target is 535 participants, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (199% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02475681, a Phase 3 study of Chronic Lymphocytic Leukemia, is active but no longer recruiting, sponsored by Acerta Pharma.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
535 participants
Enrollment target
20
Study locations

Study 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)

Primary Outcome

To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) based on IRC assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia criteria (IWCLL; Hallek et al. 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson et al. 2012), hereafter referred to as IWCLL 2008 criteria, in subjects with previously untreated CLL. PFS, de

Conditions Studied

Chronic Lymphocytic Leukemia

Interventions

  • DRUG Obinutuzumab
  • DRUG Acalabrutinib
  • DRUG Chlorambucil

Study Locations (20)

California

  • Research Site - Anaheim
  • Research Site - Los Angeles
  • Research Site - Los Angeles
  • Research Site - Los Angeles
  • Research Site - Oxnard
  • Research Site - Palo Alto

Florida

  • Research Site - Fort Myers
  • Research Site - Jacksonville
  • Research Site - Tallahassee
  • Research Site - Tallahassee
  • Research Site - Tampa

Arizona

  • Research Site - Goodyear
  • Research Site - Phoenix

Colorado

  • Research Site - Aurora
  • Research Site - Lone Tree

District of Columbia

  • Research Site - Washington D.C.

Illinois

  • Research Site - Niles

Indiana

  • Research Site - Lafayette

Kansas

  • Research Site - Wichita

Trial Details

FieldValue
Enrollment Target 535 participants
Start Date 2015-06-26
Est. Completion 2025-09-30
Phase Phase 3
Acerta Pharma

38 total trials

What the registry record for NCT02475681 still lists

NCT02475681 is an interventional study that assigns participants to a tested intervention. The registered 535 participants enrollment target is mid-sized for trials with a published cap, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (199% higher).

The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Obinutuzumab is the first listed.

NCT02475681 names 20 study sites across 9 states, led by California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT02475681 about?

NCT02475681 is a clinical study titled "Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL". 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 effic...

What is the current status of trial NCT02475681?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 535 participants. The study started on 2015-06-26. Estimated completion is 2025-09-30.

What conditions does trial NCT02475681 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.

What interventions are being tested in trial NCT02475681?

The interventions under investigation include: Obinutuzumab (DRUG), Acalabrutinib (DRUG), Chlorambucil (DRUG).

Who is sponsoring clinical trial NCT02475681?

This trial is sponsored by Acerta Pharma, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02475681 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Chronic Lymphocytic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02475681's enrollment target sits among peer trials

535 18th of 187 higher than 170 of 187 other Chronic Lymphocytic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02475681, the US trial registry maintained by the National Library of Medicine. NCT02475681 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.