A Two Cohort Pilot Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome (CRS) Management in Pediatric Patients With CD19 Expressing Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (ALL)
This is a two cohort, open-label, pilot study to describe the efficacy of administration timing of tocilizumab on CART19 (CTL019) associated cytokine release syndrome safety events in pediatric patients with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia with high versus low pre-infusion tumor burden following redirected autologous T cells transduced with the anti-CD19 lentiviral vector (CART19/CTL019).
NCT02906371 — Lymphoblastic Leukemia, Acute, Childhood
Status: Completed
http://inclinicaltrials.com/lymphoblastic-leukemia-acute-childhood/NCT02906371/
A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations
This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, 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 more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
NCT02883049 — B Acute Lymphoblastic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/b-acute-lymphoblastic-leukemia/NCT02883049/
A Pilot Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapse of Acute Lymphoblastic Leukemia
This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute lymphoblastic leukemia (ALL).
NCT02879643 — Lymphoblastic Leukemia, Acute, Childhood
Status: Recruiting
http://inclinicaltrials.com/lymphoblastic-leukemia-acute-childhood/NCT02879643/
Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia
This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone 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 blinatumomab, inotuzumab ozogamicin, and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia than chemotherapy alone.
NCT02877303 — B Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/b-acute-lymphoblastic-leukemia/NCT02877303/
Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial
The GMALL registry serves the purpose of ALL research and quality assurance. The Registry collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical routine, whether or not the patient is treated within a clinical trial.
NCT02872987 — Leukemia
Status: Recruiting
http://inclinicaltrials.com/leukemia/NCT02872987/
Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children
Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic strategies allow healing of over 80% of children. However these treatments are associated with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during treatment initiation, are the thromboembolic complications. The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no efficacy in the prevention of these thromboembolic complications. Therefore most authors consider that a multifactorial mechanism is behind these events, involving both treatment and malignant cells. The interaction of these two factors participate in the damage of the vascular endothelium. The microparticles are membrane fragments derived from budding from the membrane of activated cells or apoptosis. Their thrombogenic role is linked to the expression of coagulation activators such as tissue factor. It is also associated with their role in the modulation of signaling pathways involved in the invasiveness and angiogenesis in endothelial cells. In acute lymphoblastic leukemia, the presence and role of microparticles have not been studied. Our hypothesis is that of production of microparticles upon lysis of blasts then upon activation of endothelial cells induced by the induction therapy, participating in a procoagulant phenotype.
NCT02862652 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT02862652/
A Phase I Dose-escalation Study to Assess the Safety of AFM11 (CD19 x CD3 TandAb®) in Patients With Relapsed or Refractory Adult B-precursor Acute Lymphoblastic Leukemia
The purpose of the study is to determine the maximum tolerated dose (MTD) in patients with acute lymphoblastic leukemia (ALL) and to determine the safety and tolerability of increasing doses and different infusion times of AFM11 infusion in patients with adult B-precursor ALL
NCT02848911 — Leukemia, B-Cell
Status: Terminated
http://inclinicaltrials.com/leukemia-b-cell/NCT02848911/
A Phase 1 Study of Combining Ibrutinib, Dasatinib and Prednisone in Patients 60 Years or Older With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
This is a Phase I, single-center, open label, prospective, single-arm, dose-escalation and multi-dose study evaluating the use of ibrutinib in combination with dasatinib and prednisone therapy.
NCT02815059 — Acute Lymphoblastic Leukemia
Status: Withdrawn
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT02815059/
Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19
The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)
NCT02799550 — Leukemia
Status: Recruiting
http://inclinicaltrials.com/leukemia/NCT02799550/
An Observational Study of Patients With Philadelphia Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.
NCT02783651 — Relapsed/Refractory Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/relapsed-refractory-acute-lymphoblastic-leukemia/NCT02783651/