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Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma (UNITY-NHL)

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ClinicalTrials.gov Identifier: NCT02793583
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Mantle Cell Lymphoma Small Lymphocytic Lymphoma Biological: Ublituximab Drug: Umbralisib Biological: Bendamustine Phase 2 Phase 3

Detailed Description:
The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL, SLL, MZL, DLBCL and MCL).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma
Actual Study Start Date : May 25, 2016
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : July 1, 2025


Arm Intervention/treatment
Experimental: Umbralisib + Ublituximab
Umbralisib oral daily dose in combination with Ublituximab intravenous administration
Biological: Ublituximab
Other Name: TG-1101

Drug: Umbralisib
Other Name: TGR-1202

Experimental: Umbralisib
Umbralisib oral daily dose
Drug: Umbralisib
Other Name: TGR-1202

Experimental: Umbralisib + Ublituximab + Bendamustine
Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Biological: Ublituximab
Other Name: TG-1101

Drug: Umbralisib
Other Name: TGR-1202

Biological: Bendamustine
Other Name: Treanda




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Every 8-12 weeks, up to 2 years ]

Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Non-Hodgkin's Lymphoma including Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma
  • Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant
  • MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
  • Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Prior therapy with a PI3K delta inhibitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793583


Contacts
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Contact: TG Therapeutics Clinical Support Team 212-554-4279 clinicalsupport@tgtxinc.com

Locations
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Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
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Study Chair: Owen A O'Connor, MD, PhD Columbia University
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02793583    
Other Study ID Numbers: UTX-TGR-205
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared once the last patient visit has been completed
Keywords provided by TG Therapeutics, Inc.:
DLBCL
FL
MZL
MCL
SLL
Non-Hodgkin's Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents