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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06075238
Other study ID # PT-Blin 1.0
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date October 1, 2023
Est. completion date September 30, 2026

Study information

Verified date October 2023
Source Sichuan University
Contact Jie Ji, MD
Phone 86-28-85422373
Email jieji@scu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this phase I/II clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 68
Est. completion date September 30, 2026
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria: 1. B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT; 2. Age =16 years old and = 65 years old when signing informed consent Form (ICF); 3. KPS > 60 or ECOG 0-2; 4. The expected survival time is more than 3 months; 5. Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator; 6. Reach the standard of hematopoietic reconstitution (neutrophil count = 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count = 20×10^9/L for 7 consecutive days without platelet transfusion, Hb = 80 g /L without red blood cell transfusion); and neutrophil count = 1.5×10^9/L, platelet count = 50×10^9/L within 45 days after transplantation; 7. No central nervous system involvement or clinical symptoms after transplantation; 8. Those who have no serious functional damage to important organs of the body; 9. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures; 10. Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose. Exclusion Criteria: 1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.; 2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective; 3. Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study; 4. Poor graft function (PGF) occurred after allo-HSCT; 5. Combined with other malignant tumors and require treatment; 6. Active GVHD; 7. Have a history of allergy to Chidamide; 8. Pregnant or lactating females; 9. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome; 10. Patients with active chronic hepatitis B or active hepatitis C; 11. History of prolonged QT syndrome; 12. Patients considered by other researchers to be unsuitable for this study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
blinatumomab
The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Locations

Country Name City State
China West China Hospital of Sichuan University Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival (PFS) Progression free survival of this group of patients at the end of 2 year 2 years
Primary 100 day adverse events (AE) non-hematologic adverse events Day +100
Secondary Non-relapse mortality (NRM) Non-relapse mortality of this group of patients at the end of 6 month 6 months
Secondary Relapse rate Relapse rate of this group of patients at the end of 2 year 2 years
Secondary Overall survival (OS) Overall survival of this group of patients at the end of 2 year 2 years
Secondary Cumulative incidence of acute graft versus host disease (aGVHD) Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100 Day +100
Secondary Cumulative incidence of chronic graft versus host disease (cGVHD) Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year 2 years
See also
  Status Clinical Trial Phase
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT06111625 - Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL Phase 2
Not yet recruiting NCT06075212 - Immune Reconstitution After Allo-HSCT and Blinatumomab
Active, not recruiting NCT04849416 - A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia) Phase 2
Completed NCT00339664 - Analyses of Human Samples Collected in Clinical Trials
Completed NCT01116193 - Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Dexamethasone in Patients With Lymphoblastic Leukemia Phase 2
Terminated NCT00569179 - A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies Phase 1