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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02793583




Registration number
NCT02793583
Ethics application status
Date submitted
23/05/2016
Date registered
8/06/2016
Date last updated
21/07/2022

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
UTX-TGR-205
Universal Trial Number (UTN)
Trial acronym
UNITY-NHL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma 0 0
Follicular Lymphoma 0 0
Marginal Zone Lymphoma 0 0
Mantle Cell Lymphoma 0 0
Small Lymphocytic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Umbralisib + Ublituximab - Umbralisib oral daily dose in combination with Ublituximab intravenous administration

Experimental: Umbralisib - Umbralisib oral daily dose

Experimental: Umbralisib + Ublituximab + Bendamustine - Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Every 8-12 weeks, up to 2 years
Secondary outcome [1] 0 0
Progression-Free Survival
Timepoint [1] 0 0
From date of randomization until the date of first documented progression, assessed up through 2 years

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/07/2022
Sample size
Target
Accrual to date
Final
710
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
TG Therapeutics Investigational Trial Site - Gosford
Recruitment hospital [2] 0 0
TG Therapeutics Investigational Trial Site - Wahroonga
Recruitment hospital [3] 0 0
TG Therapeutics Investigational Trial Site - Benowa
Recruitment hospital [4] 0 0
TG Therapeutics Investigational Trial Site - South Brisbane
Recruitment hospital [5] 0 0
TG Therapeutics Investigational Trial Site - Adelaide
Recruitment hospital [6] 0 0
TG Therapeutics Investigational Trial Site - Heidelberg
Recruitment hospital [7] 0 0
TG Therapeutics Investigational Trial Site - Nedlands
Recruitment hospital [8] 0 0
TG Therapeutics Investigational Trial Site - Netherlands
Recruitment postcode(s) [1] 0 0
02250 - Gosford
Recruitment postcode(s) [2] 0 0
02076 - Wahroonga
Recruitment postcode(s) [3] 0 0
04217 - Benowa
Recruitment postcode(s) [4] 0 0
04101 - South Brisbane
Recruitment postcode(s) [5] 0 0
05000 - Adelaide
Recruitment postcode(s) [6] 0 0
03084 - Heidelberg
Recruitment postcode(s) [7] 0 0
06009 - Nedlands
Recruitment postcode(s) [8] 0 0
06009 - Netherlands
Recruitment postcode(s) [9] 0 0
2076 - Gosford
Recruitment outside Australia
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United States of America
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Alabama
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District of Columbia
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Louisiana
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Maine
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Michigan
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Minnesota
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Missouri
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Nebraska
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Israel
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Ashkelon
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Israel
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Tel Aviv
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Poprad
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Barcelona
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Madrid
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Salisbury
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Valencia
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United Kingdom
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Cambridge
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Denmark Hill
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Leeds
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Liverpool
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London
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Oxford
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United Kingdom
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Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TG Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT02793583
Trial related presentations / publications
Fowler NH, Samaniego F, Jurczak W, Ghosh N, Derenzini E, Reeves JA, Knopinska-Posluszny W, Cheah CY, Phillips T, Lech-Maranda E, Cheson BD, Caimi PF, Grosicki S, Leslie LA, Chavez JC, Fonseca G, Babu S, Hodson DJ, Shao SH, Burke JM, Sharman JP, Law JY, Pagel JM, Miskin HP, Sportelli P, O'Connor OA, Weiss MS, Zinzani PL. Umbralisib, a Dual PI3Kdelta/CK1epsilon Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2021 May 20;39(15):1609-1618. doi: 10.1200/JCO.20.03433. Epub 2021 Mar 8.
Public notes

Contacts
Principal investigator
Name 0 0
Owen A O'Connor, MD, PhD
Address 0 0
Columbia University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02793583