Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

Launched by SHENZHEN SECOND PEOPLE'S HOSPITAL · Apr 4, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called olverembatinib for patients with chronic myeloid leukemia (CML) who are in the chronic phase and have not responded well or cannot tolerate at least two other standard treatments known as second-generation tyrosine kinase inhibitors (TKIs). The goal is to see how effective and safe olverembatinib is after 12 months of treatment, focusing on the major molecular responses, which means how well the treatment helps control the leukemia.

To participate in this trial, you need to be between 18 and 75 years old and have a diagnosis of CML in the chronic phase. You should also be able to perform daily activities with little to no assistance and have good organ function. Participants will receive the study drug and will be closely monitored for any side effects and improvements in their condition. It's important to note that individuals who are allergic to the study drug, have had recent major surgery, or are pregnant or breastfeeding cannot take part in this trial. If you're interested, you will need to sign a consent form that explains the study and confirms your understanding.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years and ≤75 years.
• • Diagnosis of CML-CP.
• • ECOG performance of 0-2.
• • Adequate end organ function defined as the following: total bilirubin \<1.5xULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
• • Resistance and/or intolerance of at least two second-generation TKIs.
• • Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
• Exclusion Criteria:
• • Known to be allergic to study drug ingredients or their analogues.
• • History of undergone major surgery within 4 weeks.
• • Patients unwilling or unable to comply with the protocol.
• • Pregnant or breast-feeding patients.
• • patients with other malignant tumor.