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Closed (no longer recruiting)Last updated: 9 January 2024

This phase I trial is evaluating the safety and effectiveness of a new oral drug (TG-1701) for patients with B-cell malignancies that have not responded or gotten worse with prior treatmentsA Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

Clinical summary

Summary

This is a non-randomised trial, in which patients will be allocated to receive an oral dose of TG-1701 alone OR in combination with oral Umbralisib and Ublituximab at a fixed IV infusion on specific Days, followed by maintenance infusions.

Conditions

This trial is treating patients with B-cell malignancies.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

TG Therapeutics, Inc.

Scientific Title

A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

Eligibility

Inclusion

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

Exclusion

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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