Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by TG Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02301156
First received: November 20, 2014
Last updated: August 21, 2016
Last verified: August 2016
  Purpose
This study evaluates the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL) patients with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Ublituximab
Drug: ibrutinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:


Further study details as provided by TG Therapeutics, Inc.:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Every 8-12 weeks, up to 2 years ] [ Designated as safety issue: No ]
    To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab in combination with ibrutinib compared to ibrutinib alone

  • Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 3 years ] [ Designated as safety issue: No ]
    To assess the progression-free survival (PFS) in patients with Chronic Lymphocytic Leukemia treated with ublituximab in combination with ibrutinib compared to ibrutinib alone


Estimated Enrollment: 330
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ublituximab + ibrutinib
  • Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions
  • Ibrutinib: Fixed oral daily dose
Drug: Ublituximab
Ublituximab IV infusion
Drug: ibrutinib
Ibrutinib oral daily dose
Other Name: IMBRUVICA
Active Comparator: Ibrutinib
- Ibrutinib: Fixed oral daily dose
Drug: ibrutinib
Ibrutinib oral daily dose
Other Name: IMBRUVICA

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
  • At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
  • Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
  • Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02301156

Contacts
Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com

  Show 164 Study Locations
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Jeff Sharman, MD Willamette Valley Cancer Institute
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02301156     History of Changes
Other Study ID Numbers: UTX-IB-301 
Study First Received: November 20, 2014
Last Updated: August 21, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on August 25, 2016