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Trial record 1 of 1 for:    UTX-IB-301
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Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT02301156
Recruitment Status : Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Ublituximab Drug: ibrutinib Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Every 8-12 weeks, up to 2 years ]
    To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab in combination with ibrutinib compared to ibrutinib alone

  2. Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 3 years ]
    To assess the progression-free survival (PFS) in patients with Chronic Lymphocytic Leukemia treated with ublituximab in combination with ibrutinib compared to ibrutinib alone



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301156


  Show 116 Study Locations
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Jeff Sharman, MD Willamette Valley Cancer Institute

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02301156     History of Changes
Other Study ID Numbers: UTX-IB-301
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

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