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Study of TG-1801 in Subjects With B-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03804996
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 12, 2019
First Posted Date  ICMJE January 15, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE March 5, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2019)
  • Adverse Events That Are Related to Treatment [ Time Frame: 6 months of therapy ]
    Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities
  • Overall Response Rate [ Time Frame: 6 months of therapy ]
    Objective response in subjects treated with TG-1801
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03804996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TG-1801 in Subjects With B-Cell Lymphoma
Official Title  ICMJE A Phase 1 First-in-Human Study of Bispecific Antibody TG-1801 in Subjects With B-Cell Lymphoma
Brief Summary Phase 1 Study to Assess the Bispecific Antibody TG-1801 in Subjects with B-Cell Lymphoma
Detailed Description This is an open-label, multi-center, accelerated titration design study. Planned enrollment includes 1 subject at low dose levels. Subjects will receive weekly infusions of TG-1801 in a 4 week-cycles.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-Cell Lymphoma
Intervention  ICMJE Drug: TG-1801
Intravenous infusion over 1 hour every 4 weeks
Study Arms  ICMJE Experimental: TG-1801
TG-1801 will be administered as an intravenous infusion over 1 hour, in 4-week (28-day) cycles.
Intervention: Drug: TG-1801
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
16
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2019)
12
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed relapsed or refractory B-cell lymphoma
  • Measurable disease and adequate organ function as specified in the protocol
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.

Exclusion Criteria:

  • Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1 Day
  • Prior autologous stem cell transplant within 6 months
  • 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: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03804996
Other Study ID Numbers  ICMJE TG-1801-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TG Therapeutics, Inc.
Study Sponsor  ICMJE TG Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TG Therapeutics, Inc.
Verification Date September 2019

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