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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Jan 2014

Geographic Reach

1 country

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

December 11, 2013

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed

20 days until next milestone

Study Start

First participant enrolled

January 6, 2014

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

1.9 years

First QC Date

December 11, 2013

Last Update Submit

October 21, 2022

Conditions

Chronic Lymphocytic Leukemia Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Overall Response Rate
Up to 1 year

Study Arms (1)

Ublituximab + ibrutinib

EXPERIMENTAL

Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose

Drug: UblituximabDrug: Ibrutinib

Interventions

UblituximabDRUG

Ublituximab (IV infusion)

Ublituximab + ibrutinib

IbrutinibDRUG

Ibrutinib oral daily dose

Also known as: Ibrutinib (IMBRUVICA)

Ublituximab + ibrutinib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.