Phase 3
Completed N=126
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT02301156 ↗
Enrolled (actual)
126
Serious AEs
59.0%
Results posted
May 2022
Primary outcomePrimary: Overall Response Rate (ORR) — 84.4; 69.4 percentage of participants — p=0.0463
◆ Published Evidence
Established
49citations · ~10 / year
Ublituximab plus ibrutinib versus ibrutinib alone for patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE): a phase 3, multicentre, open-label, randomised trial.
Summary
This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR [complete response] + PR [partial response]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.
Linked Publications
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Ublituximab plus ibrutinib versus ibrutinib alone for patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE): a phase 3, multicentre, open-label, randomised trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
84.4; 69.4 | 0.0463 sig |
| SECONDARY Complete Response (CR) Rate |
18.8; 4.8 | 0.0159 sig |
| SECONDARY Minimum Residual Disease (MRD) Negativity Rate |
45.3; 9.7 | <0.0001 sig |
| SECONDARY Progression-Free Survival (PFS) |
NA; 47.2 | 0.0961 |
| SECONDARY Duration of Response (DOR) |
NA; 39.1 | 0.1486 |
| SECONDARY Time to Response (TTR) |
2.0; 3.9 | 0.0004 sig |
| SECONDARY Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) |
100; 100 | — |
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 human immunodeficiency virus (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)
Data sourced from ClinicalTrials.gov (NCT02301156) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.