Clinical Trials /

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

NCT02301156

Description:

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.

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Ublituximab</span> in Combination With <span class="go-doc-concept go-doc-intervention">Ibrutinib</span> Versus <span class="go-doc-concept go-doc-intervention">Ibrutinib</span> Alone in Patients With Previously Treated High-Risk <span class="go-doc-concept go-doc-disease">Chronic Lymphocytic Leukemia</span> (CLL)

Title

  • Brief Title: Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
  • 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)
  • Clinical Trial IDs

    NCT ID: NCT02301156

    ORG ID: UTX-IB-301

    Trial Conditions

    Chronic Lymphocytic Leukemia

    Trial Interventions

    Drug Synonyms Arms
    Ublituximab Ublituximab + ibrutinib
    ibrutinib IMBRUVICA Ublituximab + ibrutinib, Ibrutinib

    Trial 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Ublituximab + ibrutinib Experimental Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose Ublituximab, ibrutinib
    Ibrutinib Active Comparator - Ibrutinib: Fixed oral daily dose ibrutinib

    Eligibility 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)

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall Response Rate

    Progression-Free Survival

    Secondary Outcome Measures

    Trial Keywords