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

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ClinicalTrials.gov Identifier: NCT03671590
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Chronic Lymphocytic Leukemia Drug: TG-1701 Drug: Umbralisib Biological: Ublituximab Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Arm 1
TG-1701 oral daily dose
Drug: TG-1701
Oral daily dose

Experimental: Arm 2
TG-1701 + Ublituximab + Umbralisib
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, followed by maintenance infusions
Other Name: TG-1101




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 1 year ]
    To assess the overall response rate (ORR) in patients with hematologic malignancies



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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:

  • 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

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): NCT03671590


Contacts
Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com

Locations
Australia
St. Vincent's Hospital Recruiting
Melbourne, Australia
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Constantine S. Tam, MD St. Vincents Hospital

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03671590     History of Changes
Other Study ID Numbers: TG-1701-101
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Leukemia, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia