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Trial Title:
Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT
NCT ID:
NCT06075238
Condition:
Leukemia, Lymphoid
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Recurrence
Blinatumomab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
blinatumomab
Description:
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.
Arm group label:
blinatumomab
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
16 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Start date:
October 1, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075238
