Ph+ acute lymphoblastic leukemia (ALL)
Conditions
Interventions
treatment group:Treated with Inotuzumab Ozogamicin combined with olverembatinib
Sponsors
Blood Diseases Hospital, Institute of Hematology, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Clearly diagnosed relapsed or refractory Ph+ALL patients with positive Ph chromosome or BCR/ABL fusion gene; At the end of induction therapy, patients who failed to obtain CR or had obtained CR had primitive cells in peripheral blood or bone marrow (proportion >5%), or extramedullary diseases. 2. Aged at least 16 years. 3. The physical state assessment (ECOG) score of Eastern Oncology Collaboration group was 0-3. 4. Adequate organ function: (1) Total bilirubin was 1.5 times lower than the upper limit of normal; (2) Blood aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were lower than 2 times the upper limit of normal; (3) Serum creatinine <=2 mg/Dl.
Exclusion criteria
Exclusion criteria: 1. CD22 was not expressed in lymphocytes with abnormal flow cytometry phenotype; 2. Known HIV or active hepatitis; 3. Suffer from mental illness or other conditions and are unable to cooperate with the requirements of research treatment and monitoring; 4. Pregnant patients or patients unable to take appropriate contraceptive measures during treatment; 5. Suspected allergic to the test drug or any excipients thereof; 6. Active heart disease, defined as one or more of the following: (1) A history of uncontrolled or symptomatic angina; (2) Myocardial infarction less than 6 months after enrollment; (3) A history of arrhythmia requiring drug therapy or severe clinical symptoms; (4) Uncontrolled or symptomatic congestive heart failure (> NYHA class 2); (5) The ejection fraction was lower than the lower limit of the normal range; (6) The patients considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate after transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drop-out rate of transplantation;Molecular relapse after transplantation ;Overall survival;Disease-free survival after transplantation;Transplant-related mortality;Graft-versus-host disease;Major molecular biological response rate after chemotherapy;Overall response rate;Negative conversion rate of minimal residual leukemia;Complete molecular response rate after chemotherapy;Cytogenetic recurrence rate after transplantation;Adverse reaction to chemotherapy; | — |
Countries
China
Contacts
Public ContactJiang Erlie
Blood Diseases Hospital, Institute of Hematology, Chinese Academy of Medical Sciences
Outcome results
None listed