A single-center, single-arm, open-label, interventional, phase II clinical trial to evaluate the efficacy and safety of InO in B-ALL achieved CR/CRi after 1L induction chemotherapy with positive minimal residual disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Patients who achieved CR/CRi had their InO dose at 1.5mg/m2 per cycle (28days/cycle), with 0.5mg/m2 administered on days 1, 8, and 15. Patients received treatment for up to two cycles in the absence of disease progression or unacceptable toxicity.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
MRD negativity rate within the first treatment cycle
MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Complete MRD response rates
Complete MRD response is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
Time frame: At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
Duration of MRD negativity rate
The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status.
Time frame: From enrollment to the end of Cycle 1 or Cycle 2, which achieves MRD negative first (each cycle is 28 days)
MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively
The variation of MRD level from baseline to post cycle 1, cycle 2, respectively
Time frame: From enrollment to the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
Relapse-free Survival (RFS)
RFS is defined as the time from the date of CR until the date of relapse or death
Time frame: Up to 5 years from enrollment
Overall Survival (OS)
OS is defined as the time from enrollment to date of death due to any cause.
Time frame: Up to 5 years from enrollment
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