MedTrace Logo

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

NCT01039376 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2019-07-30

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Leukaemia, Lymphocytic, Chronic

Interventions

BIOLOGICAL

Ofatumumab

Ofatumumab for maintenance therapy as IV infusions every 8 weeks . The first dose was 300 mg followed 1 week later by 1000 mg and 1000 mg every 8 weeks thereafter for up to 2 years.

OTHER

Observation

Observation/Safety Evaluation

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-06
Primary Completion
2017-02-20
Completion
2018-06-26

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

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 NCT01039376 on ClinicalTrials.gov