NCT07443488

Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Therapy Followed by HSCT in Ph+ ALL

A Study on the Efficacy and Safety of Olverembatinib Combined With Inotuzumab Ozogamicin as First-Line Consolidation Therapy Bridging to Hematopoietic Stem Cell Transplantation in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HSCT
• Ph+ ALL

Interventions

Type	Name	Description
DRUG	Olverembatinib+INO	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

Timeline

• Start date: 2026-03-14
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2026-03-02
• Last updated: 2026-03-02