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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Inotuzumab Ozogamicin
Drugintravenous infusion: Cycle 1: D1 0.8mg/m2, D8 0.5mg/m2, D15 0.5mg/m2, if the MRD turn negative, cycle 2: D1 0.5mg/m2, D8 0.5mg/m2, D15 0.5mg/m2， if not，cycle 2: D1 0.8mg/m2, D8 0.5mg/m2, D15 0.5mg/m2
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the rate of MRD-
For Ph-negative ALL: undetectable MRD by flow cytometry At the end of Cycle 1 and Cycle 2 (each cycle is 21 days) . For Ph-positive ALL: undetectable MRD by flow cytometry and absence of quantifiable BCR::ABL1 transcript by PCR At the end of Cycle 1 and Cycle 2(each cycle is 21 days).
Time frame
At the end of Cycle 1 and Cycle 2(each cycle is 21 days)Secondary outcomes
1
Progression-Free Survival (PFS)
It is measured from the date of entry into this trial to the date of progression or death
Time frame
1 year2
Overall survival (OS)
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Time frame
1 year3
Adverse events in hematological system
Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction
Time frame
1 year4
Adverse events in other organs or systems
Record of adverse events in other organs or systems during and after designed venetoclax combined azacitidine regimen induction.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
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