Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Ther⦠(NCT07443488) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Therapy Followed by HSCT in Ph+ ALL
20 participantsStarted 2026-03-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (1) Clearly diagnosed acute lymphoblastic leukemia, with Philadelphia chromosome positivity or BCR-ABL fusion gene positivity; with CD22 expression on the surface of leukemia cells; failure to achieve minimal residual disease (MRD) negativity after first induction chemotherapy (BCR-ABL fusion gene level ā„ 10-ā“), where the induction regimen is standard chemotherapy combined with any tyrosine kinase inhibitor targeting BCR-ABL1.
* (2) Age greater than or equal to 18 years.
* (3) Able to provide informed consent independently.
* (4) Must have adequate organ function: renal and hepatic functions as follows: AST, ALT, and ALP less than 2 times the upper limit of normal (ULN), total bilirubin less than 1.5 times ULN; creatinine clearance greater than 50 mL/min; pancreatic function: serum amylase not exceeding 1.5 times ULN, serum lipase not exceeding 1.5 times ULN; normal cardiac function: ejection fraction (EF) \> 60%, pulmonary artery systolic pressure ⤠50 mmHg.
* (5) Negative for HIV, HBV, and HCV.
* (6) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
* (7) Informed consent must be signed before the start of study procedures. For subjects aged 18 years and above, informed consent should be signed by the patient themselves or their immediate family members. Considering the patient's condition, if signing by the patient themselves is detrimental to treatment, the legal guardian or immediate family member may sign the informed cā¦
What they're measuring
1
MRD clearance
Timeframe: one month
Trial details
NCT IDNCT07443488
SponsorInstitute of Hematology & Blood Diseases Hospital, China