Ublituximab + Ibrutinib in Select B-cell Malignancies

A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02013128

Enrollment

Registered

2013-12-17

Start date

2014-01-06

Completion date

2015-12-31

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma

Brief summary

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.

Interventions

DRUGUblituximab

Ublituximab (IV infusion)

DRUGIbrutinib

Ibrutinib oral daily dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed. * Refractory to or relapsed after at least 1 prior treatment regimen * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion criteria

* Any major surgery, chemotherapy or immunotherapy within the last 21 days * Known hepatitis B virus, hepatitis C virus or HIV infection * Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded. * Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies	28 days (1 cycle of therapy)	To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary

Measure	Time frame	Description
Overall Response Rate	Up to 1 year	To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with Ibrutinib

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026