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Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V) (ULTRA-V)

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ClinicalTrials.gov Identifier: NCT03801525
Recruitment Status : Active, not recruiting
First Posted : January 11, 2019
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 11, 2019
Last Update Posted Date January 23, 2023
Actual Study Start Date  ICMJE May 16, 2019
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2021)
  • Phase 2: Complete Response (CR) Rate [ Time Frame: Up to 12 months ]
  • Phase 2: Overall Response Rate [ Time Frame: Up to 12 months ]
  • Phase 3: Progression-Free Survival [ Time Frame: 60 months ]
    Progression-Free Survival in subjects treated with U2-V compared with U2
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2019)		 Overall Response Rate [ Time Frame: Up to 12 months ]
Objective response in subjects treated with ublituximab + umbralisib + venetoclax
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2021)
  • Adverse Events That Are Related to Treatment [ Time Frame: 6 months of therapy ]
    Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results
  • Phase 3: Overall Response Rate [ Time Frame: Up to 12 months ]
    Objective response in subjects treated with ublituximab + umbralisib + venetoclax
  • Rate of Undetectable Minimal Residual Disease (MRD) [ Time Frame: 60 months ]
  • Phase 2: Time to Response (TTR) [ Time Frame: Up to 12 months ]
  • Phase 2: Duration of Response (DOR) [ Time Frame: 60 months ]
  • Phase 3: Complete Response (CR) Rate [ Time Frame: Up to 12 months ]
  • Phase 3: Overall Survival (OS) [ Time Frame: 72 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2019)		 Adverse Events That Are Related to Treatment [ Time Frame: 6 months of therapy ]
Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)
Official Title  ICMJE Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects With Chronic Lymphocytic Leukemia (CLL)
Brief Summary ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)
Detailed Description This is an open-label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of the combination of ublituximab + umbralisib + venetoclax (U2-V) compared to the combination of ublituximab + umbralisib (U2) in patients with either treatment naïve or previously treated CLL/ small lymphocytic lymphoma (SLL)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Intervention  ICMJE
  • Drug: Ublituximab
    • recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody
    • administered as an intravenous (IV) infusion
    Other Name: TG-1101
  • Drug: Umbralisib
    • inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)
    • Tablet form
    Other Names:
    • TGR-1202
    • UKONIQ
  • Drug: Venetoclax
    • B-cell lymphoma 2 (BCL-2) inhibitor
    • Tablet form, to be taken orally
    Other Name: Venclexta®
Study Arms  ICMJE
  • Experimental: Phase 2: Previously Treated CLL (BTK-Not Refractory)
    Interventions:
    • Drug: Ublituximab
    • Drug: Umbralisib
    • Drug: Venetoclax
  • Experimental: Phase 2: Previously Treated CLL (BTK-Refractory)
    Interventions:
    • Drug: Ublituximab
    • Drug: Umbralisib
    • Drug: Venetoclax
  • Experimental: Phase 2: Treatment Naïve CLL
    Interventions:
    • Drug: Ublituximab
    • Drug: Umbralisib
    • Drug: Venetoclax
  • Experimental: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
    Interventions:
    • Drug: Ublituximab
    • Drug: Umbralisib
    • Drug: Venetoclax
  • Experimental: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)
    Interventions:
    • Drug: Ublituximab
    • Drug: Umbralisib
  • Experimental: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
    Interventions:
    • Drug: Ublituximab
    • Drug: Umbralisib
    • Drug: Venetoclax
  • Experimental: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)
    Interventions:
    • Drug: Ublituximab
    • Drug: Umbralisib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2021)		 700
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2019)		 90
Estimated Study Completion Date  ICMJE March 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that warrants treatment
  • Adequate organ system function as specified in the protocol
  • Ability to follow protocol procedures.

Exclusion Criteria:

  • Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1
  • Prior exposure to any PI3K inhibitor or venetoclax
  • Autologous hematologic stem cell transplant within 6 months of study entry. Prior allogeneic hematologic stem cell transplant is excluded
  • Active Hepatitis B or Hepatitis C.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03801525
Other Study ID Numbers  ICMJE U2-VEN-207
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data for this study will be shared after the last patient visit has been completed.
Current Responsible Party TG Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE TG Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TG Therapeutics, Inc.
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP