Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05940961
Other study ID # szINO
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 1, 2022
Est. completion date August 1, 2025

Study information

Verified date September 2023
Source The First Affiliated Hospital of Soochow University
Contact Sheng-Li Xue, MD
Phone 0086-0512-67781139
Email slxue@suda.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. INO-VATE confirmed that Inotuzumab Ozogamicin can be used to achieve high remission (CR/CRi) and MRD-negative rates, serving as an effective bridge to HSCT, and it is associated with increased OS and PFS in patients with R/R BCP ALL. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria: 1. Patients aged = 15 and = 65 years. 2. Patients diagnosed with CD22+ B-ALL according to 2023 NCCN Acute Lymphoblasts Leukaemias diagnosis standard. 3. 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, 4. ECOG performance status score less than 3. 5. Expected survival time #3 months. 6. Patients without serious heart, lung, liver, or kidney disease. 7. Ability to understand and voluntarily provide informed consent. Exclusion Criteria: 1. Patients who are allergic to the study drug or drugs with similar chemical structures. 2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception. 3. Active infection. 4. Active bleeding. 5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment. 6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met. 7. Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, ALT/AST > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value). 8. Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment. 9. Surgery on the main organs within the past six weeks. 10. Drug abuse or long-term alcohol abuse that would affect the evaluation results. 11. Patients who have received organ transplants (excepting bone marrow transplantation). 12. Patients not suitable for the study according to the investigator's assessment.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Inotuzumab Ozogamicin
intravenous 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

Locations

Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (7)

Lead Sponsor Collaborator
Sheng-Li Xue, MD Affiliated Hospital of Nantong University, First Affiliated Hospital Bengbu Medical College, Jining Medical University, Northern Jiangsu Province People's Hospital, Suzhou Hospital of Traditional Chinese Medicine, The Second People's Hospital of Huai'an

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). At the end of Cycle 1 and Cycle 2(each cycle is 21 days)
Secondary Progression-Free Survival (PFS) It is measured from the date of entry into this trial to the date of progression or death 1 year
Secondary 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. 1 year
Secondary Adverse events in hematological system Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction 1 year
Secondary 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. 1 year
See also
  Status Clinical Trial Phase
Completed NCT00766883 - Problem-Solving Education for Caregivers and Patients During Stem Cell Transplant Phase 2
Recruiting NCT06148610 - Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
Recruiting NCT04690933 - AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
Completed NCT02564458 - Fitness in Allogeneic Stem Cell Transplantation N/A
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Not yet recruiting NCT01714557 - Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation N/A
Completed NCT00701688 - Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Phase 1
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Recruiting NCT04092309 - Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation N/A
Completed NCT00000603 - Cord Blood Stem Cell Transplantation Study (COBLT) Phase 2
Completed NCT02663622 - Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002) Phase 2
Recruiting NCT04937634 - Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation Phase 1
Recruiting NCT04203108 - ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis Phase 4
Withdrawn NCT03279133 - Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients. Phase 4
Completed NCT03654599 - Effects of Digital Stories Intervention on Psychosocial Well-being N/A
Completed NCT05151406 - Myths and Misconceptions About HSCT in a Limited Resource Region N/A
Completed NCT02241005 - Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci N/A
Recruiting NCT03689465 - PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis Phase 4
Recruiting NCT04868786 - Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation Phase 1
Recruiting NCT03010579 - Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation Phase 4