A Phase 2 interventional study of Inotuzumab ozogamicin in Acute Lymphocytic Leukemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment
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.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 489 are open to participants now.
This study's enrollment of 31 is below the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Functions of the main organs are normal, if the following criteria are met:
Exclusion Criteria:
Patients with severe and / or uncontrolled diseases, such as:
Each subject will be treated with Inotuzumab Ozogamicin
Drug: Inotuzumab ozogamicin
Patients who achieved CR/CRi had their InO dose at 1.5mg/m2 per cycle (28days/cycle), with 0.5mg/m2 administered on days 1, 8, and 15. Patients received treatment for up to two cycles in the absence of disease progression or unacceptable toxicity.
Also known as: CMC-544
MRD negativity rate within the first treatment cycle
MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Complete MRD response rates
Complete MRD response is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
Time frame: At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
Duration of MRD negativity rate
The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status.
Time frame: From enrollment to the end of Cycle 1 or Cycle 2, which achieves MRD negative first (each cycle is 28 days)
MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively
The variation of MRD level from baseline to post cycle 1, cycle 2, respectively
Time frame: From enrollment to the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
Relapse-free Survival (RFS)
RFS is defined as the time from the date of CR until the date of relapse or death
Time frame: Up to 5 years from enrollment
Overall Survival (OS)
OS is defined as the time from enrollment to date of death due to any cause.
Time frame: Up to 5 years from enrollment
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Precursor Cell Lymphoblastic Leukemia-Lymphoma→
Institute of Hematology & Blood Diseases Hospital, China