Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15-65
SponsorSheng-Li Xue, MD
About this trial
As part of postremission consolidative therapy, the decision to proceed with hematopoietic stem cell transplantation is a recommendable regimen in ALL therapy. However, The recurrence rate is high after transplantation. Minimal Residual Disease (MRD) is an important factor affecting the effect of HSCT. The hematologic recurrence rate of MRD-positive patients with adult ALL is high.
MRD- is associated with better prognosis. Therefore, maintaining MRD- after transplantation is necessary for long-term survival. The purpose of this study is to explore the efficacy and safety of Inotuzumab Ozogamicin in the treatment of minimal residual disease recurrence after HSCT of ALL patients.
Eligibility criteria
Qualifiers
Patients aged ≥ 15 and ≤ 65 years.
Patients diagnosed with CD22+ B-ALL according to 2023 NCCN Acute Lymphoblasts Leukaemias diagnosis standard.
CD22+ B-ALL patients with MRD recurrence after HSCT. Ph+ ALL patients were eligible if treatment with 1 or more second-generation BCR::ABL1 tyrosine kinase inhibitors (TKIs) had failed,
ECOG performance status score less than 3.
Disqualifiers
Patients who are allergic to the study drug or drugs with similar chemical structures.
Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
Active infection.
Active bleeding.
Trial design
Treatments tested in this trial
- Inotuzumab Ozogamicin
Treatment groups
42 Participants
are divided into 1 treatment groupSponsors and collaborators
Sheng-Li Xue, MD
Lead sponsor
The First Affiliated Hospital of Soochow University
Sponsor institution
Jining Medical University
Collaborator
The Second People's Hospital of Huai'an
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
Affiliated Hospital of Nantong University
Collaborator
Suzhou Hospital of Traditional Chinese Medicine
Collaborator
Northern Jiangsu People's Hospital
Collaborator
Source ClinicalTrials.gov