Clinical trial

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

Name

TG-UPCC-108

Description

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.

Trial arms

Trial start

2015-09-18

Estimated PCD

2021-11-04

Trial end

2021-11-04

Status

Completed

Phase

Early phase I

Treatment

Umbralisib

A once daily oral agent

Arms:

TG-1501 + Ublituximab + Umbralisib

Other names:

TGR-1202

ublituximab

IV anti-CD20 monoclonal antibody

Arms:

TG-1501 + Ublituximab + Umbralisib

Other names:

TG-1101

TG-1501

IV immunotherapy for cancer

Arms:

TG-1501 + Ublituximab + Umbralisib

Size

Primary endpoint

Determine Acceptable Adverse Events That Are Related to Treatment

6 months of therapy

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}

Updated at

2022-10-20

1 organization

3 products

2 indications

Product

Umbralisib

Indication

Chronic Lymphocytic Leukemia

Indication

Organization

Product

Product