Daratumumab for T Cell ALL With MRD-positive After Standard Chemotherapy
- Conditions
- ALL, Adult
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria:<br><br> 1. Patients with newly diagnosed T-cell acute lymphoblastic leukemia confirmed by cell<br> morphology and immunophenotype had flow MRD=0.01% 3 months after chemotherapy; or<br> patients with T-cell acute lymphoblastic leukemia relapsed achieved CR again after<br> salvage chemotherapy, but the flow MRD was =0.01%<br><br> 2. Age =18 years old, male or female<br><br> 3. The expression of CD38 in tumor cells was positive<br><br> 4. Men and women who may give birth agree to and use effective contraceptive methods<br><br> 5. Main organ function assessment criteria: total bilirubin < 1.5× upper normal limit<br> (ULN), glutamic oxalic aminotransferase (AST) and glutamic alanine aminotransferase<br> (ALT) =2.5×ULN; Serum creatinine < 2×ULN; Myocardial enzyme < 2×ULN; Serum amylase<br> =1.5×ULN; Left ventricular ejection fraction (LEF) was > 45%<br><br> 6. Understand and sign the informed consent and agree to comply with the study<br> requirements<br><br>Exclusion Criteria:<br><br> 1. SAEs related to the study emerged during the study, and the investigator judged that<br> the necessity of quitting the project was greater than the benefit<br><br> 2. In case of any situation in which the subjects could not tolerate the study regimen,<br> the investigator assessed that the necessity of withdrawal from the regimen<br> outweighed the benefit<br><br> 3. The subject had an allergic reaction to any drug of the study regimen or other<br> conditions that prevented the regimen from continuing<br><br> 4. Subjects voluntarily asked to withdraw from the study at any time<br><br> 5. Any situation in which the investigator determines that the benefit of withdrawing<br> from the study outweighs the benefit
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of conversion from MRD+to MRD- by flow cytometry after 1 cycle of daretuzumab treatment
- Secondary Outcome Measures
Name Time Method overall survival overall survival overall survival;Disease-free survival (DFS);Cumulative incidence of relapse (CIR);duration of MRD-negative response;Rate of conversion from MRD+to MRD- by NGS;30-day mortality;60-day mortality