Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With… (NCT05456698) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy
China31 participantsStarted 2022-10-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry.
✓. Age ≥18 years
✓. ECOG PS score: 0 to 2
✓. Functions of the main organs are normal, if the following criteria are met:
✓. Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN)