To study the minimal residual disease (MRD) clearance rate of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation chemotherapy in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who have not achieved MRD remission after initial induction chemotherapy.
In the previous study, which employed a regimen of olverembatinib combined with inotuzumab ozogamicin to clear MRD in patients with Ph⁺ ALL before bridging to transplantation, the results indicated that this combination achieved a high MRD clearance rate in patients with poor prognosis, along with a high bridging transplantation rate, significantly improving patient outcomes. In the present study, the investigators propose the use of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation therapy. This approach aims to reduce the number of pre-transplant chemotherapy cycles for patients who do not achieve MRD negativity after initial induction chemotherapy, enabling them to attain deeper remission more rapidly. It is expected to provide more transplantation opportunities, including the potential for autologous hematopoietic stem cell transplantation, for this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
First-Line Consolidation Chemotherapy with Olverembatinib + Inotuzumab Ozogamicin Olverembatinib: 40 mg every other day (QOD), from day 1 to day 28. Inotuzumab Ozogamicin: 1.2 mg/m² per cycle, administered as: 0.6 mg/m² on day 2 0.6 mg/m² on day 8
MRD clearance
Time frame: one month
Overall Survival
Time frame: one year after HSCT
Relapse free survival
Time frame: one year after HSCT
Relapse rate
Time frame: one year after HSCT
Treatment related mortality
Time frame: one year after HSCT
rate of bridging to HSCT
Time frame: one year
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