Ublituximab + Ibrutinib in Select B-cell Malignancies

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma
• Interventions: Drug: Ublituximab; Drug: Ibrutinib

• Registration Number: NCT02013128
• Lead Sponsor: TG Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-17
• Study Start: 2014-01-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2022-10
• Disposition First Submitted: 2022-10-21
• Disposition First Submitted QC: 2022-10-21
• Last Update Submitted: 2022-10-21
• Disposition First Posted: 2022-10-24
• Last Update Posted: 2022-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ublituximab + ibrutinib	Ublituximab	Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
Ublituximab + ibrutinib	Ibrutinib	Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇺🇸 Vancouver, Washington, United States