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NCT02242942 · ClinicalTrials.gov registry record · Phase 3

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

A Phase 3 study of Lymphocytic Leukemia, Chronic, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
445
Enrollment target
20
Study locations

NCT02242942: Completed Phase 3 study of Lymphocytic Leukemia, Chronic, sponsored by Hoffmann-La Roche.

NCT02242942 is a Phase 3 study of Lymphocytic Leukemia, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 445 participants, above the 55-participant average among 3 other Lymphocytic Leukemia, Chronic trials with a reported enrollment target (709% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02242942, a Phase 3 study of Lymphocytic Leukemia, Chronic, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
445 participants
Enrollment target
20
Study locations

Study Summary

This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years

Primary Outcome

PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) \>/= 50% increase in the absolute number of circulating lymphocytes to at least 5\*10\^9/L, 2) Appearance of new palpable lymph nodes (\> 15 mm in longest diameter) or any new extra-nodal lesion; 3) \>/= 50% increase in the longest diameter of any previous site of lymphadeno

Conditions Studied

Lymphocytic Leukemia, Chronic

Interventions

  • DRUG Obinutuzumab
  • DRUG Venetoclax
  • DRUG Chlorambucil

Study Locations (20)

Other

  • Hospital Italiano - Buenos Aires
  • Tiroler Landeskrankenanstalten Ges.M.B.H. - Innsbruck
  • Medizinische Universität Wien - Vienna

Victoria

  • Box Hill Hospital - Box Hill
  • The Northern Hospital - Epping
  • Monash Medical Centre - Melbourne

California

  • City of Hope - Duarte
  • UC San Diego Health System - La Jolla

New South Wales

  • Liverpool Hospital - Liverpool BC
  • Tweed Hospital - Tweed Heads

Queensland

  • The Townsville Hospital - Douglas
  • Princess Alexandra Hospital Woolloongabba - Woolloongabba

South Australia

  • Royal Adelaide Hospital - Adelaide
  • Ashford Cancer Centre Research - Ashford

Arizona

  • Banner MD Anderson Cancer Center - Gilbert

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 445 participants
Start Date 2014-12-31
Est. Completion 2025-08-27
Phase Phase 3
Hoffmann-La Roche

909 total trials

What the finished NCT02242942 record still lists

NCT02242942 is an interventional study that assigns participants to a tested intervention. The registered 445 participants enrollment target is mid-sized for trials with a published cap, above the 55-participant average among 3 other Lymphocytic Leukemia, Chronic trials with a reported enrollment target (709% higher).

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

NCT02242942 names 20 study sites across 12 states, led by Other, Victoria, California.

Frequently Asked Questions

What is clinical trial NCT02242942 about?

NCT02242942 is a clinical study titled "Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia". This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study...

What is the current status of trial NCT02242942?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 445 participants. The study started on 2014-12-31. Estimated completion is 2025-08-27.

What conditions does trial NCT02242942 study?

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

What interventions are being tested in trial NCT02242942?

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

Who is sponsoring clinical trial NCT02242942?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02242942 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT02242942, the US trial registry maintained by the National Library of Medicine. NCT02242942 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.