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Clinical trial

A Phase II Study Evaluating the Safety and Efficacy of Umbralisib (TGR-1202) in Combination With Ublituximab in Patients With Treatment Naïve Follicular Lymphoma and Small Lymphocytic Lymphoma

ID
Name
UTX-TGR-203
Description
This is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).
Trial arms
Trial start
2019-07-10
Estimated PCD
2022-05-16
Trial end
2022-05-31
Status
Terminated
Phase
Early phase I
Treatment
Ublituximab
- anti-CD 20 monoclonal antibody administered via IV infusion
Arms:
Ublituximab + Umbralisib
Other names:
TG-1101
Umbralisib
- PI3K Delta Inhibitor oral daily dose
Arms:
Ublituximab + Umbralisib
Other names:
TGR-1202
Size
34
Primary endpoint
Overall Response Rate (ORR)
Up to 22 months
Eligibility criteria
Inclusion Criteria: * Confirmed diagnosis of FL or SLL. * Measurable disease that requires treatment * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 Exclusion Criteria: * Currently or previously received treatment for their lymphoma * Received wide field radiotherapy within 28 days or limited field radiation within 14 days of Cycle 1 Day 1 * Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}
Updated at
2023-07-24

1 organization

2 products

2 indications

Organization
TG Therapeutics
Product
Ublituximab
Indication
Follicular Lymphoma
Indication
Small Lymphocytic Lymphoma
Product
Umbralisib