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NOT YET RECRUITING
NCT07443488
PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-03-14

Completion Date

2027-10-31

Last Updated

2026-03-02

Healthy Volunteers

No

Conditions

Interventions

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