Acute lymphoblastic leukemia
Conditions
Interventions
Experimental group: Ogaituzumab, venecla and dexamethasone regimens
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Relapsed/Refractory Ph-negative CD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL) 2. CD22 expression in bone marrow blasts >= 20% 3. Age >= 18 years, no restriction on gender or race 4. ECOG performance status = 30 ml/min 6. Subjects who have previously received autologous or allogeneic hematopoietic stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy, and if they are at least 60 days post-cell infusion with no active grade 2 or higher graft-versus-host disease (GVHD), are eligible. Patients must discontinue calcineurin inhibitors for 2 weeks prior to enrollment. 7. Patients with a history of central nervous system lymphoma (CNSL) are eligible, provided there is no active CNSL at the time of enrollment. 8. The patient or their legally authorized representative must agree to participate in the clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria shall not be included in this study: 1. Leukemia cells do not express CD22 or have mixed lineage leukemia; 2. Ph-positive acute lymphoblastic leukemia; 3. History of clinically significant liver disease, such as hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS); or severe/ uncontrolled liver disease, such as cirrhosis, decompensated liver disease, acute or chronic hepatitis. 4. Use of strong CYP3A4 inhibitors (including but not limited to fluconazole, voriconazole, posaconazole, etc.) or inducers (such as rifampin, rifabutin, phenytoin, carbamazepine, or St. John's wort) within 7 days prior to enrollment. 5. Consumption of grapefruit, grapefruit products, or starfruit within 3 days before starting venetoclax treatment. 6. Malabsorption syndrome or other conditions that would prevent the oral administration of venetoclax (e.g., inability to swallow tablets). 7. Previous treatment with obinutuzumab or venetoclax, or known allergy to any component of obinutuzumab or venetoclax. 8. Presence of severe/uncontrolled diseases, such as: a) Severe cardiac dysfunction with an ejection fraction below the lower limit of normal or severe arrhythmia; uncontrolled hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); b) Liver diseases, such as cirrhosis, nodular regenerative hyperplasia, or active hepatitis; c) HIV-positive status. 9. Active central nervous system leukemia or the presence of other concurrent malignancies. 10. Active or uncontrolled other diseases/infections as determined by the physician. 11. Subjects evaluated by the investigator as having serious concomitant diseases that pose a life-threatening risk to the patient or interfere with the completion of the study. 12. Pregnant or breastfeeding women. 13. Subjects who are unable or unwilling to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compound remission rate after treatment;Micro-residual disease to negative rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Recurrence-free survival;Time to response;Non-recurrent mortality rate;Hematological and non-hematological toxicity; | — |
Countries
China
Contacts
Public ContactQin Weiwei
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed