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Ublituximab + Ibrutinib in Select B-cell Malignancies

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TG Therapeutics

Status and phase

Completed
Phase 2
Phase 1

Conditions

Mantle Cell Lymphoma
Chronic Lymphocytic Leukemia

Treatments

Drug: Ibrutinib
Drug: Ublituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02013128
UTX-IB-104

Details and patient eligibility

About

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

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

66 participants in 1 patient group

Ublituximab + ibrutinib
Experimental group
Description:
Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
Treatment:
Drug: Ibrutinib
Drug: Ublituximab

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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