An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Target Total Therapy for Adult Early T-cell Progenitor Acute Lymphoblastic Leukemia/Lymphoma
ETP-ALL is a recently recognized high-risk subgroup and the optimal therapeutic approaches are poorly characterized. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial is aimed to evaluate the safety and effect of a novel oral histone deacetylase inhibitor chidamide for adult ETP-ALL/LBL in CHINA.
NCT03553238 — Leukemia, Acute
Status: Recruiting
http://inclinicaltrials.com/leukemia-acute/NCT03553238/
Phase II Study of the Combination of Low-Intensity Chemotherapy and Blinatumomab in Patients With Philadelphia Chromosome Negative Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
This phase II trial studies how well low-intensity chemotherapy and blinatumomab work in treating patients with Philadelphia chromosome negative acute lymphoblastic leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as dexamethasone, filgrastim, pegfilgrastim, cyclophosphamide, methotrexate, cytarabine and vincristine sulfate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving low-intensity chemotherapy and blinatumomab may work better at treating acute lymphoblastic leukemia.
NCT03518112 — Recurrent B Acute Lymphoblastic Leukemia
Status: Terminated
http://inclinicaltrials.com/recurrent-b-acute-lymphoblastic-leukemia/NCT03518112/
A Phase IB/II Study of Venetoclax (ABT-199) in Combination With Liposomal Vincristine in Patients With Relapsed or Refractory T-Cell or B-Cell Acute Lymphoblastic Leukemia
This phase Ib/II clinical trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine liposomal in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vincristine liposomal, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with vincristine liposomal may work better in treating patients with acute lymphoblastic leukemia.
NCT03504644 — Recurrent Adult Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/recurrent-adult-acute-lymphoblastic-leukemia/NCT03504644/
Phase II Trial for the Treatment of Older Patients With Newly Diagnosed CD19 Positive, Ph/BCR-ABL Negative B-precursor Acute Lymphoblastic Leukemia With Sequential Dose Reduced Chemotherapy and Blinatumomab (EWALL-BOLD)
The trial proposed here attempts to reduce induction chemotherapy to phase I of standard induction in patients with B-precursor ALL. Induction phase II will be replaced by blinatumomab. The initial treatment phase is followed by sequential chemotherapy and further blinatumomab cycles.
NCT03480438 — B-Precursor ALL
Status: Completed
http://inclinicaltrials.com/b-precursor-all/NCT03480438/
An Open-label, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
This study is being done to evaluate the rate of hematological response (complete remission/complete remission with partial hematological recovery [CR/CRh*]) induced by blinatumomab in Chinese adults with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
NCT03476239 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT03476239/
Nutritional Status in Children With Acute Lymphoblastic Leukemia (ALL) Undergoing Treatment at the National Pediatric Oncology Unit in Guatemala City, Guatemala
This study proposes to investigate the association of nutritional status of a children assessed by body mass index (BMI), triceps skinfold thickness (TSFT), and mid upper arm circumference (MUAC), with body composition, measured by dual-energy X-ray absorptiometry (DEXA), in 60 children undergoing treatment of ALL at Unidad Nacional de Oncologia Pediatrica (UNOP), in Guatemala City, Guatemala. The study also aims to establish normative values of body composition in children residing in an LMIC by examining 160 healthy siblings of children under treatment, and to measure habitual physical activity in children with acute lymphoblastic leukemia (ALL) at diagnosis and during therapy.
NCT03471416 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT03471416/
Phase I/II Study of Anti-CD19 Chimeric Antigen Receptor-Expressing T Cells in Pediatric Patients Affected by Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia and Non Hodgkin Lymphoma
The primary objective of this phase I study is to evaluate the safety and to establish the recommended dose of CD19-CART01 infused in pediatric patients affected by relapsed/refractory B-ALL or NHL with measurable Bone Marrow (BM) involvement. The phase II extension is aimed at testing the efficacy of the treatment at the optimal dose defined in the phase I.
NCT03373071 — CD19-LNH
Status: Active, not recruiting
http://inclinicaltrials.com/cd19-lnh/NCT03373071/
Observation of the Effect of Chemotherapy Combined With Tyrosinase Inhibitor on the Reactivation of CMV and EBV in Patients With Acute Lymphoblastic Leukemia
Philadelphia-chromosome-positive or partial ph-like acute lymphoblastic leukemia (ALL) preferred chemotherapy combined with tyrosine kinase inhibitors (TKIS) therapy. Recently we found that there were cytomegalovirus reactivation and even cytomegalovirus infection in three ALL patients treated with chemotherapy combined with TKIs. However, the cytomegalovirus risk after dasatinib use in patients with philadelphia-chromosome-positive ALL is still unknown. It is reported that dasatinib can be observed in the treatment of philadelphia-chromosome-positive leukemia patients with significant increase in large granular lymphocytes, the cytomegalovirus is often positive, and this part of the patient's prognosis is relatively good. Dasatinib can inhibit SRC and TEC kinase, and induce immune function inhibition,and in vitro experiments have confirmed that it inhibits the immune function of T cells and NK cells. In this study, we examined the potential association between cytomegalovirus AND EBV reactivation the treatment of chemotherapy combined with TKIs, and the numbers of large granular cells and NK cell activity.
NCT03331211 — Leukemia, Lymphoblastic, Acute
Status: Recruiting
http://inclinicaltrials.com/leukemia-lymphoblastic-acute/NCT03331211/
A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation（HSCT）
This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT
NCT03327285 — Acute Lymphoblastic Leukemia(ALL)
Status: Active, not recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-all/NCT03327285/
Adoptive Therapy With MB-CART19.1 in Patients With Relapsed/Refractory CD19-positive B Cell Acute Lymphoblastic Leukemia
Precursor-B acute lymphoblastic leukemia (ALL) is the most common cancer in childhood. Despite major advances in ALL therapy, 20% of children and 40-50% of adults fail state-of-the art first-line treatment. But there is a strong need for alternative treatments to cure chemotherapy-refractory and relapsed B cell malignancies in pediatric patients. Relapsed and refractory B cell malignancies remain a therapeutic challenge, as these diseases are characterized by adverse survival. These cancers share a cell origin from the B-cell lineage and consequent surface expression of B-lineage markers such as CD19 and CD22. Chimeric antigen receptor (CAR) engineered T cell therapy has recently emerged as a new modality to target B cell malignancies. CARs couple a single-chain Fv (scFv) domain directed against a B-lineage-specific antigen to T-cell activating intracellular signaling domains. CAR gene-modified T cell interaction with target cells occurs in a HLA-independent fashion, so that a single vector can be used to treat all patients with cancers that express the target antigen. Miltenyi Biotec has established a semi-automated manufacturing process that can be made available to academic settings for systematic exploration of CAR strategies in advanced clinical studies. Closed-system operation, improved robustness, simplified work flows, and reduced labor intensity, while maintaining strict adherence to regulatory guidelines, allows for decentralized manufacturing. In the proposed phase II study, the investigator will explore autologous 2nd generation CD19 CAR T cell products in patients with relapsed and refractory disease incurable with standard therapies.
NCT03321123 — Precursor B-Lymphoblastic Lymphoma/Leukaemia Refractory
Status: Not yet recruiting
http://inclinicaltrials.com/precursor-b-lymphoblastic-lymphoma-leukaemia-refractory/NCT03321123/