
Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From...
Acute Lymphoblastic LeukemiaPediatric2 moreThe innovation of this protocol is the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors. we have proposed a two-stage stratification into risk groups: Initially: Standard risk: patients with no rearrangement of the KMT2A gene. Intermediate risk: patients with rearrangement of the KMT2A gene without damage to the central nervous system. High risk: patients with rearrangement of the KMT2A gene with lesions of the central nervous system. According to the results of induction therapy: The high-risk group includes patients from the standard risk group with an MRD level of more than 0.1% after the induction course and from the intermediate risk group with MRD-positive (PCR) after HR1 block. The allocation of children in the first year of life without the rearranged KMT2A gene into a separate group seems to be logical, since the prognosis in this group is better than in children with the rearranged KMT2A gene. In this protocol, non-intensive therapy with consolidations and maintenance therapy remains for those who achieve a low MRD level (less than 0.1%) after a course of induction. The rest of the patients move into a high-risk group: they receive blinatumomab and HSCT. The concept of therapy for patients at intermediate risk is based on the rate at which MRD-negativity is achieved: standard consolidation and maintenance therapy for those who became MRD-negative at the end of induction, "block" chemotherapy for those who were positive at the end of induction, but achieved negativity after HR1 block, blinatumomab with HSCT for those who have preserved the MRD after the HR1 block. For high-risk patients, a combination of immunotherapy (blinatumomab - a bispecific CD3 / CD19 T-cell activator) and HSCT in the first remission was chosen.

Effect of Rifaximin on Gut Bacterial Flora Post Stem Cell Transplant in Patients With Acute Leukemia...
Acute LeukemiaGoal: This study is a randomized phase II interventional study. The purpose of this study is to see if addition of oral rifaximin tablets during allogeneic stem cell transplant can improve the quality of gut microbiome and reduce chances of death, infections and graft versus host disease (GVHD) post-transplant. The study objectives are as follows: Primary Objective: To determine the impact of rifaximin on gut microbial diversity and compare it with controls. Secondary Objectives: a. To determine non-relapse mortality at 1-year post transplant in patients who receive peri-transplant transplant rifaximin and compare it with controls. b. To compare the incidence of severe GVHD in patients who receive peri-transplant rifaximin with the controls. c. To determine impact of gut decontamination with rifaximin on incidence of MDR sepsis and usage of higher antibiotics (e.g. Carbapenems, colistin, tigecycline, ceftazidime avibactum and ceftriaxone-sulbactam EDTA) in first 6 months post BMT. d. To determine the impact of rifaximin induced gut manipulation on immune reconstitution, T cell repertoire post-transplant and cytokine profile. Exploratory objective: To use single cell transcriptomics (SCT) to identify immune cell profile in gut biopsies post allogeneic stem cell transplant whenever biopsy is done, to correlate the impact of microbiome on gut immunity. Intervention: Tab Rifaximin 200 mg will be given orally twice daily from day -8 to day +60 of allogeneic stem cell transplant in acute leukemia patients. This will be in addition to standard of care post-transplant treatment. Comparator Agent: Standard of care treatment including standard anti GVHD measures, antibiotic support and transfusions as needed.

Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected...
Accelerated Phase Chronic Myelogenous LeukemiaBCR-ABL1 Positive13 moreThis randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV is a virus that may reproduce and cause disease and even death in patients with lowered immune systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe, weakened virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity (the ability to recognize and respond to an infection) to CMV. This may help to reduce both CMV complications and reduce the need for antiviral drugs in patients undergoing a donor hematopoietic cell transplant.

High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host...
Acute LeukemiaChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma14 moreThis pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic...
Accelerated Phase Chronic Myelogenous LeukemiaBCR-ABL1 Positive14 moreThis randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the body build an effective immune response and may reduce cytomegalovirus events after donor stem cell transplant.

TT52CAR19 Therapy for B-cell Acute Lymphoblastic Leukaemia (B-ALL)
B Acute Lymphoblastic LeukemiaPBLTT52CAR19 modified T cells are allogenic engineered human T cells (defined as TT52CAR19 +TCRαβ-) prepared for the treatment of CD19+ B cell leukaemia. The cells are from healthy adult volunteer donors and are not HLA-matched. They have been transduced to express and anti-CD19 chimeric antigen receptor (CAR19) using a lentiviral vector that also incorporates CRISPR guides for genome editing of CD52 and TRAC loci in the presence of transiently provided Cas9. Recognition by TT52CAR19 T cells mediates eradication of CD19+ leukaemia and other CD19+ B cells through T cell mediated cytotoxicity. This study aims to apply PBLTT52CAR19 T cells to secure molecular remission in children with relapsed/refractory B-ALL ahead of programmed allogeneic stem cell transplantation. The cells are to be used in a time-limited manner for their anti-leukaemia effects and then depleted by standard pre- transplant conditioning.

Cognitive Behavioral Therapy in Helping Patients With Acute Myeloid Leukemia or Lymphoma With Cancer-Related...
Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome3 moreThis trial studies how well cognitive behavioral therapy works in helping patients with acute myeloid leukemia or lymphoma with cancer-related fatigue. Behavioral therapy uses methods to help patients change the way they think and act. Behavioral skills may help patients with acute myeloid leukemia or lymphoma cope with anxiety, depression, and other factors that may influence their level of cancer-related fatigue.

Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic...
Acute Lymphoblastic LeukemiaTranscranial Direct Current Stimulation1 moreBrief Overview: Children and adolescents diagnosed with cancer will experience problems with learning, memory and attention during and after completing their cancer therapy. There are many factors that contribute to this problem, but investigators have recently identified that chemotherapy agents used in treating Acute Lymphoblastic Leukemia (ALL) may disrupt normal brain development. A novel device has been developed that may help correct this disruption. Direct Current Stimulation (DCS) uses a very low level of constant electrical current to stimulate specific parts of the brain. It has been used in patients with stroke to great benefit. Our study at St. Jude Children's Research Hospital is designed to see if this technique will benefit survivors of childhood cancer. Specifically, investigators wish to see if stimulating one part of the brain gives a greater benefit than stimulating another part of the brain. Primary Objective Evaluate the feasibility of conducting repeated on-site Transcranial Direct Current Stimulation (tDCS) in children who are long-term survivors of Secondary Objectives To estimate the potential efficacy for powering a future larger study using tDCS to improve cognitive performance in children by suppressing over connected neural hubs in long-term survivors of childhood ALL. To compare the performance of anodal stimulation of the frontal lobe to cathodal suppression of the superior temporal lobe on cognitive performance.

A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been...
Advanced Lymphoid LeukemiaThe purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
Chronic Myelogenous LeukemiaThe main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment