TGRX-678-2001 = Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients [China]

What is the purpose of the study

TGRX-678 is a new drug under investigation for the treatment of CML.

This is a study to evaluate the safety and efficacy of TGRX-678 in patients with CML in accelerated phase (AP) who are relapsed or refractory from treatment with third-generation tyrosine kinase inhibitors (TKI).

What will happen during the study

All patients will be given TGRX-678 as tablets (240 mg) once daily.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged at least 18 years
• have been diagnosed with chronic myelogenous leukemia in accelerated phase (CML-AP) by bone marrow morphological test, molecular biology test or cytogenetic tests
• are relapsed or refactory from 3rd-generation tyrosine kinase inhibitor (TKI) treatment
  • patients without T315I mutation must have received 1st, 2nd and 3rd generation TKIs
  • patients with T315I mutation must have received treatment with olverembatinib or ponatinib
• have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
• have a life expectancy of at least 3 months.

Further criteria apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• have been treated with a TKI within 7 days of receiving the first dose of the study drug
• have unresolved non-hematological adverse reactions related to previous TKI treatment
• have received other anticancer therapies
• are in need of concomitant immunosuppressive therapy
• have undergone hemapoietic stem cell transplantation
• have active central nervous system conditions
• have already reached major hematological response
• used to progress to blast phase (BP).

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by of the U. S. National Institutes of Health.

Study centers / principal investigators

China

Beijing
Peking University People’s Hospital
Beijing, 100044
PrincipaI Investigator: Qian Jiang, MD