Status:
NOT_YET_RECRUITING
Daratumumab for T Cell ALL With MRD-positive After Standard Chemotherapy
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
ALL, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
T-ALL accounts for about 15%-25% of Ph-negative ALL, and its clinical prognosis is worse than B-ALL. The successful application of immunotherapy has brought revolutionary progress to the treatment of ...
Detailed Description
Daratumumab is administered once a week at a dose of 16 mg/kg for a total of 4 times (Day1,8,15,22) in one cycle. Conditions patients can use up to two cycles of treatment.
Eligibility Criteria
Inclusion
- Patients with newly diagnosed T-cell acute lymphoblastic leukemia confirmed by cell morphology and immunophenotype had flow MRD≥0.01% 3 months after chemotherapy; or patients with T-cell acute lymphoblastic leukemia relapsed achieved CR again after salvage chemotherapy, but the flow MRD was ≥0.01%
- Age ≥18 years old, male or female
- The expression of CD38 in tumor cells was positive
- Men and women who may give birth agree to and use effective contraceptive methods
- Main organ function assessment criteria: total bilirubin \< 1.5× upper normal limit (ULN), glutamic oxalic aminotransferase (AST) and glutamic alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine \< 2×ULN; Myocardial enzyme \< 2×ULN; Serum amylase ≤1.5×ULN; Left ventricular ejection fraction (LEF) was \> 45%
- Understand and sign the informed consent and agree to comply with the study requirements
Exclusion
- SAEs related to the study emerged during the study, and the investigator judged that the necessity of quitting the project was greater than the benefit
- In case of any situation in which the subjects could not tolerate the study regimen, the investigator assessed that the necessity of withdrawal from the regimen outweighed the benefit
- The subject had an allergic reaction to any drug of the study regimen or other conditions that prevented the regimen from continuing
- Subjects voluntarily asked to withdraw from the study at any time
- Any situation in which the investigator determines that the benefit of withdrawing from the study outweighs the benefit
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06570915
Start Date
December 1 2025
End Date
September 1 2028
Last Update
October 1 2025
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