Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Ph+ALL
The Safety and Efficacy of Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Adult Ph + Acute Lymphoblastic Leukemia
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Erlie Jiang
- Phone Number: +86-15122538106
- Email: jiangerlie@ihcams.ac.cn
Study Contact Backup
- Name: Xiaoyu Zhang
- Phone Number: +86-18202579691
- Email: zhangxiaoyu@ihcams.ac.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Olverembatinib as maintenance therapy or preemptive therapy post-HSCT
Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.
|
Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2-year RFS after transplantation
Time Frame: 2 year after HSCT
|
2-year relapse-free survival after transplantation
|
2 year after HSCT
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2024065
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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