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Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671590
Recruitment Status : Active, not recruiting
First Posted : September 14, 2018
Last Update Posted : April 24, 2023
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 14, 2018
Last Update Posted Date April 24, 2023
Actual Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2022)		 Maximum Tolerated Dose acceptable for participants [ Time Frame: From first dose up to 30 days post last dose (Up to approximately 4.8 years) ]
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)		 Maximum Tolerated Dose acceptable for participants [ Time Frame: 28 days (1 cycle of therapy) ]
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2022)		 Overall Response Rate [ Time Frame: Up to approximately 4.8 years ]
To assess the overall response rate (ORR) in patients with hematologic malignancies
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2018)		 Overall Response Rate [ Time Frame: Up to 1 year ]
To assess the overall response rate (ORR) in patients with hematologic malignancies
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Official Title  ICMJE A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Brief Summary This is a Phase 1 trial to evaluate the safety, pharmacokinetics and efficacy of TG-1701, a Bruton's Tyrosine Kinase (BTK) inhibitor in patients with relapsed or refractory B-cell malignancies
Detailed Description This Phase I clinical trial aims to evaluate the safety of the investigational drug TG-1701 both as a single-agent and in combination with other investigational drugs, specifically ublituximab and umbralisib.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: TG-1701
    Oral daily dose
  • Drug: Umbralisib
    Oral Daily Dose
    Other Name: TGR-1202
  • Biological: Ublituximab
    Ublituximab at a fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days)
    Other Name: TG-1101
Study Arms  ICMJE
  • Experimental: Arm 1
    TG-1701 oral daily dose
    Intervention: Drug: TG-1701
  • Experimental: Arm 2
    TG-1701 + Ublituximab + Umbralisib
    Interventions:
    • Drug: TG-1701
    • Drug: Umbralisib
    • Biological: Ublituximab
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
Actual Enrollment  ICMJE
 (submitted: September 19, 2022)		 172
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2018)		 50
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
  • Adequate organ function

Exclusion Criteria:

  • Prior therapy with a BTK inhibitor (ibrutinib, acalabrutinib, other)
  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
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 Australia,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03671590
Other Study ID Numbers  ICMJE TG-1701-101
Has Data Monitoring Committee No
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: No
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
Study Chair: Constantine S. Tam, MD St. Vincents Hospital
PRS Account TG Therapeutics, Inc.
Verification Date April 2023

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