B-cell Acute Lymphoblastic Leukemia
Conditions
Keywords
IFN-α, CAR-T
Brief summary
The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).
Detailed description
This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.
Interventions
COMBINATION_PRODUCTIFN-α combined with CAR-T cell therapy
Adults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle. Children: 14 daily intramuscular injections 200mg/m\^2 of Interferon-α for a 28-day cycle. CAR T cell: (1-2)×10\^7/kg, intravenously infusion.
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed refractory and relapsed acute B-lymphoblastic leukemia. 2. Age 12-65. 3. Eastern Cooperative Oncology Group (ECOG) score 0-2. 4. Target on leukemia is \>20% positive detected with flowcytometry. 5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification. 5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL. 6.No other immunotherapy was received within 3 months.
Exclusion criteria
1. Patients are pregnant or lactating. 2. Patients with congenital immunodeficiency. 3. Patients with central nervous system leukemia. 4. Patients with uncontrolled active infection. 5. Patients with active hepatitis B or hepatitis C infection. 6. Patients with HIV infection. 7. Patients with atrial or venous thrombosis or embolism. 8. Patients with myo-infarction or severe arrythmia in the recent 6 months. 9. Other comorbidities that investigators considered not suitable for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 2 years | ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 2 years | time from enrollment to the date of death from any cause |
| Leukemia-free survival (LFS) | 2 years | time from enrollment to the date of primary refractory disease, or relapse from CR, or death from any cause |
| Cumulative incidence of relapse(CIR) | 2 years | time from the date of achievement of a remission until the date of relapse |
| the duration of CAR-T cells in patients | 2 years | the time of CAR-T cells' persistence in blood and the copies of CAR-T cells |
| Number of adverse events | 2 years | adverse events are evaluated with CTCAE V5.0 |
Countries
China
Contacts
Primary Contactxiaowen tang, Ph.D
Backup Contactdepei wu, Ph.D
Outcome results
None listed