Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02535286

Enrollment

Registered

2015-08-28

Start date

2015-09-18

Completion date

2021-11-04

Last updated

2022-10-20

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

Conditions

Chronic Lymphocytic Leukemia, Richter Syndrome

Brief summary

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Interventions

DRUGUmbralisib

A once daily oral agent

BIOLOGICALublituximab

IV anti-CD20 monoclonal antibody

BIOLOGICALTG-1501

IV immunotherapy for cancer

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 diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation * 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 14 days * Known hepatitis B virus, hepatitis C virus or HIV infection * Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)

Design outcomes

Primary

Measure	Time frame	Description
Determine Acceptable Adverse Events That Are Related to Treatment	6 months 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	The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy

Countries

United States

Outcome results

None listed

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