B-cell Acute Lymphoblastic Leukemia
Conditions
Brief summary
To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
Detailed description
High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.
Interventions
DRUGBlinatumomab
Blinatumomab will be bridged to conventional BUCY conditioning regimen.
OTHERConventional therapy
Control group will be given conventional BUCY conditioning regimen.
Sponsors
Fujian Medical University Union Hospital
Zhongda Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First People's Hospital of Changzhou
Wuxi People's Hospital
First Affiliated Hospital of Wannan Medical College
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission. 2. ECOG score is 0-2. 3. Expecting life span is more than 6 months. 4. Patients are free from severe organ dysfunction.
Exclusion criteria
1. Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) \<30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) \>2.5mg/ dL or blood Creatinine clearance rate \< 30ml/min. 2. Patients are combined with infection or other complications that can not tolerate chemotherapy. 3. Patients are suffering from central nervous system/solitary extramedullary leukemia. 4. Patients are considered as tumer progression. 5. Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks. 6. Pregnant and lactating women will not be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | From the 1st day to the 720th days after enrollment. | The time from randomization to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with negative minimal residual disease (MRD) | From the 1st day to the 720th days after enrollment. | Negative MRD is defined as below 10-4 by flow cytometry. |
| Progression-Free Survival (PFS) | From the 1st day to the 720th days after enrollment. | It is defined as the total survival of a patient after the hematopoietic stem cell transplantation, until the tumor recurrence or death from any cause. |
| Cumulative incidence of relapse (CIR) | From the 1st day to the 720th days after enrollment. | From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event. |
Countries
China
Contacts
Primary ContactHuizhu Kang, MD
Backup ContactMeng Zhou, MD
Outcome results
None listed