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

  • STATUS
    Recruiting
  • End date
    Jun 16, 2023
  • participants needed
    50
  • sponsor
    TG Therapeutics, Inc.
Updated on 16 April 2021
cancer
tyrosine
lymphoma
b-cell lymphoma

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

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.

Details
Condition Lymphoma, Lymphoma, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, non-hodgkin's lymphoma (nhl), leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma
Treatment ublituximab, Umbralisib, TG-1701
Clinical Study IdentifierNCT03671590
SponsorTG Therapeutics, Inc.
Last Modified on16 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Lymphocytic Leukemia or Non-Hodgkin's Lymphoma or Lymphoma or Lymphocytic Leukemia, Chronic?
Do you have any of these conditions: non-hodgkin's lymphoma (nhl) or Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia or small lymphocytic lymphoma or Lymphocytic Leukemia, Chronic ...?
Do you have any of these conditions: leukemia chronic lymphocytic or chronic lymphocytic leukemia (cll) or non-hodgkin's lymphoma (nhl) or Chronic Lymphocytic Leukemia or Non-Hodgkin's Ly...?
Do you have any of these conditions: leukemia chronic lymphocytic or small lymphocytic lymphoma or Lymphoma or Chronic Lymphocytic Leukemia or Lymphocytic Leukemia, Chronic or Non-Hodgkin...?
Do you have any of these conditions: Chronic Lymphocytic Leukemia or non-hodgkin's lymphoma (nhl) or leukemia chronic lymphocytic or small lymphocytic lymphoma or Lymphocytic Leukemia, Ch...?
Do you have any of these conditions: Lymphocytic Leukemia, Chronic or chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma or Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leu...?
Do you have any of these conditions: Lymphoma or Non-Hodgkin's Lymphoma or Lymphocytic Leukemia, Chronic or Chronic Lymphocytic Leukemia or chronic lymphocytic leukemia (cll) or small lym...?
Do you have any of these conditions: leukemia chronic lymphocytic or chronic lymphocytic leukemia (cll) or Non-Hodgkin's Lymphoma or Lymphocytic Leukemia, Chronic or Lymphoma or non-hodgk...?
Do you have any of these conditions: chronic lymphocytic leukemia (cll) or Chronic Lymphocytic Leukemia or Lymphoma or non-hodgkin's lymphoma (nhl) or Non-Hodgkin's Lymphoma or Lymphocyti...?
Do you have any of these conditions: non-hodgkin's lymphoma (nhl) or chronic lymphocytic leukemia (cll) or Chronic Lymphocytic Leukemia or Non-Hodgkin's Lymphoma or Lymphoma or small lymp...?
Do you have any of these conditions: Lymphocytic Leukemia, Chronic or Chronic Lymphocytic Leukemia or small lymphocytic lymphoma or non-hodgkin's lymphoma (nhl) or leukemia chronic lympho...?
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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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