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Terminated Phase 3 Interventional Results available

Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy

ClinicalTrials.gov ID: NCT01039376

Public ClinicalTrials.gov record NCT01039376. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 7:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.

Study identification

NCT ID
NCT01039376
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
480 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 6, 2010 (Actual)
Primary completion
Feb 20, 2017 (Actual)
Completion
Jun 26, 2018 (Actual)
Last update posted
Jul 30, 2019

2010 – 2018

United States locations

U.S. sites
43
U.S. states
24
U.S. cities
40
Facility City State ZIP Site status
Novartis Investigative Site Gilbert Arizona 85234 —
Novartis Investigative Site Tucson Arizona 85710 —
Novartis Investigative Site Tucson Arizona 85715 —
Novartis Investigative Site Jonesboro Arkansas 72401 —
Novartis Investigative Site Berkeley California 94704 —
Novartis Investigative Site La Verne California 91750 —
Novartis Investigative Site Sacramento California 95815 —
Novartis Investigative Site Sacramento California 95816 —
Novartis Investigative Site San Pablo California 94806 —
Novartis Investigative Site Hartford Connecticut 06105 —
Novartis Investigative Site Gainesville Florida 32610 —
Novartis Investigative Site Lake Worth Florida 33461 —
Novartis Investigative Site Orlando Florida 32806 —
Novartis Investigative Site Pembroke Pines Florida 33028 —
Novartis Investigative Site West Palm Beach Florida 33401 —
Novartis Investigative Site Macon Georgia 31201 —
Novartis Investigative Site Savannah Georgia 31405 —
Novartis Investigative Site Post Falls Idaho 83854 —
Novartis Investigative Site Indianapolis Indiana 46202 —
Novartis Investigative Site Iowa City Iowa 52242 —
Novartis Investigative Site Westwood Kansas 66205 —
Novartis Investigative Site Metairie Louisiana 70006 —
Novartis Investigative Site Cumberland Maryland 21502 —
Novartis Investigative Site Hagerstown Maryland 21742 —
Novartis Investigative Site Worcester Massachusetts 01655 —
Novartis Investigative Site Detroit Michigan 48202 —
Novartis Investigative Site Springfield Missouri 65807 —
Novartis Investigative Site St Louis Missouri 63110 —
Novartis Investigative Site Henderson Nevada 89014 —
Novartis Investigative Site New Brunswick New Jersey 08901 —
Novartis Investigative Site Albuquerque New Mexico 87110 —
Novartis Investigative Site Albuquerque New Mexico 87131 —
Novartis Investigative Site Mineola New York 11501 —
Novartis Investigative Site Rochester New York 14621 —
Novartis Investigative Site Chapel Hill North Carolina 27599-7305 —
Novartis Investigative Site Durham North Carolina 27710 —
Novartis Investigative Site Philadelphia Pennsylvania 19104 —
Novartis Investigative Site Greenville South Carolina 29601 —
Novartis Investigative Site Chattanooga Tennessee 37421 —
Novartis Investigative Site Knoxville Tennessee 37916 —
Novartis Investigative Site Memphis Tennessee 38120 —
Novartis Investigative Site Orem Utah 84058 —
Novartis Investigative Site Salt Lake City Utah 84106 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 160 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01039376, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 30, 2019 · Synced Oct 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01039376 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →