Clinical trial: NCT06339775
Section: Confidentiality
Subsections: 7. Privacy Protection:

If you decide to participate in this study, the study doctor and other investigators will use your medical information. This information may include your name, address, telephone number, medical history, and information obtained at your study follow-up. In the study analysis process and the published study results, your name and other information with relevant identity identification records will be kept confidential and not publicly used. Information that can identify you will not be disclosed to members outside of the study team without your permission. To ensure that the study is conducted as required, members of the Ethics Review Committee may access your personal data at the study site if necessary.
Clinical trial: NCT06339775
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 4. Potential Benefits Of The Study:|5. Study Risks And Discomforts:

Acute B lymphocytic leukemia (B-ALL) allogeneic hematopoietic stem cell transplantation has a very poor prognosis and a short survival. After treatment with this clinical study, your disease may be alleviated, causing prolonged survival, but it may not be effective. We cannot guarantee that can improve your health, but you participate in the study data, will be acute B lymphocyte leukocyte patients after heterogenic hematopoietic stem cell transplantation relapse treatment options to provide evidence, in the future may help people who need treatment, increase the understanding of human physiology and behavior and benefit the whole society.

You may feel uncomfortable or risky during certain examinations, such as:
1. Collect blood samples: drawing blood from the arm may cause pain, swelling, slight dizziness and rare infection.  
2. Bone marrow puncture: the site of bone marrow collection may cause pain and infection of the puncture site.  
About the study drug: Side effects can occur when using any drug. Your study doctor will ask if you have any side effects during each treatment. The risks of this clinical study are adverse effects of treatment with belintuzumab and DLI. Based on the information observed in previous clinical trials, it is speculated that the following adverse reactions may occur during the clinical studies, which may vary from person to person. Your study doctor may recommend that you suspend the study drug and treat you accordingly to control your adverse effects.  
(一) Belintoeuzumab related adverse reactions (detailed see belumab instructions) 1. cytokine release syndrome 2. nervous system toxicity 3. infection 4. tumor lysis syndrome 5. neutropenia and febrile neutropenia 6. The impact on driving and use of mechanical ability 7. The liver enzymes rise 8. pancreatitis 9. leukoencephalopathy, etc.  
(二) DLI adverse effects: myelosuppression, graft versus-host disease, infection, etc.
In addition, there may be currently unknown adverse reactions or risks. You will be promptly informed of any important new information that may affect your willingness to continue in this study.
Clinical trial: NCT06339775
Section: Procedures
Subsections: 3. Study Process And Methods:

Acute B lymphocytic leukemia (B-ALL), seen regularly after allogeneic hematopoietic stem cell transplantation, was treated with sequential donor lymphocyte infusion (DLI).  
For patients with positive MRD, belintouzumab 28 μ g 5-15 days was followed by DLI (MNC infusion was approximately 510 ^ 7 / kg to 110 ^ 8 / kg).  
In patients with hematologic relapse, belintoeuromab 9 μ g d1-4,11.66 μ gd 5-7,28 μ gd 8 (8 to 21 days) before DLI (MNC infusion was approximately 510 ^ 7 / kg to 110 ^ 8 / kg).
Clinical trial: NCT06339775
Section: Purpose of Research
Subsections: 2. Study Objectives:

Acute lymphoblastic leukemia (ALL) is a malignant hematological disorder Chemotherapy as well as hematopoietic stem cell transplantation.  
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the effective or even the only means to cure ALL and other malignant hematological diseases, but it still has a high recurrence rate after allogeneic acute lymphoblastic leukemia hematopoietic stem cell transplantation, and the prognosis of relapsed patients after transplantation is very poor, with an average survival time of about 5.5 months. There is no uniform treatment plan for relapsed patients after allogeneic HSCT. Donor lymphocyte infusion (DLI) is the primary salvage therapy for post-transplant relapse, but in the treatment of ALL patients, less than 20% of patients achieve reremission. Recurrence after ALL allogeneic HSCT is still an urgent clinical problem.  
Belintouzumab is the first CD19 positive and CD3 positive targeted immunotherapy drug approved by the US FDA, and has also been approved for relapsed or refractory B-ALL in adults and children in China. By connecting CD3 on the T cell receptor complex with CD19 expressed on B cell line-derived cells, belintoeuromab clusters T cells with target cells by forming cytolytic synapses, thereby activating endogenous T cells and enabling them to directional resolve CD19 + cells to achieve tumor cell killing. Belintuzumab in an effective salvage therapy for refractory acute B lymphoblastic leukemia in this patient population.  
In this study, sequential DLI after acute B lymphoblastic leukemia allogeneic hematopoietic stem cell transplantation relapse (including MRD relapse and hematology relapse), observe the overall survival, disease-free survival, complications, adverse reactions and other indicators, explore the treatment plan of patients with acute B lymphoblastic leukemia allogeneic hematopoietic stem cell transplantation relapse.
Clinical trial: NCT06339775
Section: Withdrawal from Study
Subsections: 9. Free To Exit:

As a subject, you may be informed of the information and progress of the study and voluntarily decide to (continue) or not (continue). After participation, regardless of whether the injury occurred or was serious, Scientific Research and Clinical Trials Ethics Committee of the First Affiliated Hospital of Zhengzhou University Address: No.43, University Road, Zhengzhou City, Henan Province Tel: 0371-66295219 Page number (page 1 of 6)58 you may choose to notify the investigator to withdraw from the study. The data after your withdrawal from the study will not be included in the study results, and any medical treatment and interests will not be affected.  
If you continue to participate in the study, the investigator will also discontinue the study.  
If you have questions about the study content, please contact the study doctor at __0371-66862272______; if you have questions related to your rights, contact the ethics committee at the footer of the informed consent form.