Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Ph+ALL

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Olverembatinib to see how well it works as a treatment after patients receive a special type of stem cell transplant for a specific type of leukemia known as Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). The goal is to find out if Olverembatinib can help prevent the leukemia from coming back after the transplant. The trial will involve about 50 patients who are at least 18 years old and have survived more than 30 days after their transplant. Patients must also have certain health criteria met, such as good kidney and liver function.

Participants in this trial can expect to take Olverembatinib every other day for up to two years after their transplant, starting between two to three months after the procedure. The dose may be adjusted based on their health needs. It's important to know that this trial is not yet recruiting, meaning they are still setting things up and haven't started enrolling patients. If you're considering participating, you'll need to give your consent, and your medical team will be there to support you throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ( 1 ) Acute lymphoblastic leukemia with positive Ph chromosome or BCR / ABL fusion gene ; after allogeneic hematopoietic stem cell transplantation, and survived for more than 30 days after transplantation.
• • ( 2 ) Age older than or equal to 18 years old ( 3 ) Informed consent can be signed by themselves. ( 4 ) Adequate organ function must be met : renal function and liver function are as follows : serum creatinine is 2 times lower than the normal upper limit, AST, ALT and ALP are lower than the normal upper limit of 3 times, and total bilirubin is lower than the normal upper limit of 3 times ( if the liver GVHD is clearly diagnosed, less than or equal to 5 × ULN ) ).
• • ( 5 ) HIV negative, HBV and HCV negative. ( 6 ) The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.
• • ( 7 ) Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.
• Exclusion Criteria:
• • ( 1 ) Hematology remission was evaluated at 1 month after transplantation, and complete donor chimerism was achieved.
• • ( 2 ) Severe cardiovascular diseases ( including myocardial infarction, unstable angina pectoris, severe arrhythmia and congestive heart failure, etc. ) occurred during the previous use of the third generations of TKI treatment.
• • ( 3 ) Uncontrolled infection at the time of enrollment ; severe complications of mechanical ventilation or hemodynamic instability ; those who had undergone autologous or allogeneic stem cell transplantation; ( 4 ) The serological reaction of known HIV or active hepatitis C virus is positive ; ( 5 ) suffering from mental illness or other illness and can not cooperate with the research treatment and monitoring requirements ; ( 6 ) being unable or unwilling to sign the consent ; ( 7 ) pregnant or lactating women ; ( 8 ) Patients with other special conditions who were assessed as unqualified by the researchers.