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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT03198234 Recruiting - Hodgkin's Lymphoma Clinical Trials

Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders

T-allo10
Start date: August 30, 2017
Phase: Phase 1
Study type: Interventional

A significant number of patients with hematologic malignancies need a hematopoietic stem cell transplant (HSCT) to be cured. Only about 50% of these patients have a fully matched donor, the remaining patients will require an HSCT from a mismatched related or unrelated donor. Almost 60% of these mismatched donor HSCTs will result in graft-versus-host disease (GvHD), which can cause significant morbidity and increased non-relapse mortality. GvHD is caused by the donor effector T cells present in the HSC graft that recognize and react against the mismatched patient's tissues. Researchers and physicians at Lucile Packard Children's Hospital, Stanford are working to prevent GvHD after HSCT with a new clinical trial. The objective of this clinical program is to develop a cell therapy to prevent GvHD and induce graft tolerance in patients receiving mismatched unmanipulated donor HSCT. The cell therapy consists of a cell preparation from the same donor of the HSCT (T-allo10) containing T regulatory type 1 (Tr1) cells able to suppress allogenic (host-specific) responses, thus decreasing the incidence of GvHD. This is the first trial of its kind in pediatric patients and is only available at Lucile Packard Children's Hospital, Stanford. The purpose of this phase 1 study is to determine the safety and tolerability of a cell therapy, T-allo10, to prevent GvHD in patients receiving mismatched related or mismatched unrelated unmanipulated donor HSCT for hematologic malignancies.

NCT ID: NCT03197714 Completed - Clinical trials for Acute Myeloid Leukemia

Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia

Start date: September 7, 2017
Phase: Phase 1
Study type: Interventional

Phase Ib, open-label, dose-escalation clinical trial to evaluate the best-tolerated doses in Acute Myeloid Leukaemia (AML) relapsed or refractory to chemotherapy. This open-label, nonrandomized trial will comprise 2 stages. A dose escalation stage will characterize the safety, tolerability and maximum tolerated dose (MTD), of OPB-111077. Subsequently, an expansion stage will further evaluate the safety and antitumor activity of OPB-111077 in AML relapsed or refractory to chemotherapy. Enrollment to the expansion cohort will begin following determination of the MTD. Approximately 6-12 patients will be included in the phase I part of this clinical trial. Additional patients will be included in the expansion cohort up to a total of 15 patients. The expansion cohort will serve to further evaluate safety simultaneously with preliminary efficacy. Patients will be selected and included in the study after testing the response to the drug with the Vivia Biotech ex vivo CDx PharmaFlow PM test. PharmaFlow PM test is a companion diagnostic (CDx) tool that provides a complete pharmacological profile for each individual, allowing the detection of patients resistant to OPB-111077 and enriching the study in patients that respond to the drug. The third of patients more sensitive to OPB-11077 wil be included in the study.

NCT ID: NCT03194932 Completed - Clinical trials for Acute Myeloid Leukemia

Study of Venetoclax in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage

Start date: July 11, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and determine the best dose of venetoclax and cytarabine when given with or without idarubicin in treating pediatric patients with acute myeloid leukemia (AML) that did not respond to treatment (refractory) or has come back after treatment (relapsed). PRIMARY OBJECTIVE: Determine a tolerable combination of venetoclax plus chemotherapy in pediatric patients with relapsed or refractory AML or acute leukemia of ambiguous lineage. The primary endpoints are the recommended phase 2 doses (RP2D) of venetoclax plus cytarabine and venetoclax plus cytarabine and idarubicin. SECONDARY OBJECTIVE: Estimate the overall response rate to the combination of venetoclax and chemotherapy in pediatric patients with relapsed or refractor AML or acute leukemia of ambiguous lineage. The secondary endpoints are the rates of complete remission (CR) and complete remission with incomplete count recovery (CRi) for patients treated at the RP2D.

NCT ID: NCT03194685 Completed - AML, Adult Clinical Trials

Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Start date: May 5, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2a dose escalation and dose ranging study of FF-10101-01 in subjects with relapsed or refractory acute myeloid leukemia to determine the safety, tolerability, PK and preliminary efficacy. A total of 9 cohorts will be enrolled in Phase 1 to establish the Maximum Tolerated Dose (MTD). Phase 2a will consist of up to 3 dose levels (high, medium, and low) of which subjects with FLT3 mutations will randomly be assigned.

NCT ID: NCT03190499 Completed - Clinical trials for Acute Myeloid Leukemia

Quality of Life in Children With Cancer

sicc
Start date: August 1, 2017
Phase:
Study type: Observational

Childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers and lymphomas are the most common ones among them. During medical treatment children with cancer are at risk of neuromuscular and musculoskeletal complications such as reduced muscle strength, gross and fine motor performance impairment, decreased energy consumption. These neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and quality of life of the children. Childhood cancers have negative effects on sleep. The aim of this study is to identify the status of sleep, fatigue, and quality of life in children with various types of cancer and to examine the relationship between these conditions.The general situation of children will be determined according to findings from this study.

NCT ID: NCT03190278 Recruiting - Clinical trials for Relapsed/Refractory Acute Myeloid Leukemia

Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

AMELI-01
Start date: June 19, 2017
Phase: Phase 1
Study type: Interventional

Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 (UCART123v1.2) and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

NCT ID: NCT03188874 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)

Start date: September 2010
Phase:
Study type: Observational [Patient Registry]

This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute myeloid leukemia. Investigator's sites: 51 sites in Germany. Primary objectives: - Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry. - Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS) - Documentation of treatment strategy

NCT ID: NCT03187691 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia

Start date: August 2019
Phase: Phase 2
Study type: Interventional

A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)

NCT ID: NCT03187288 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS

Start date: May 25, 2018
Phase: Phase 1
Study type: Interventional

This is a phase 1 study of investigational drug CFI-400945 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. The purpose of this phase 1 study is to see how safe and tolerable the study drug is and to determine the best dose (maximum tolerated dose or recommended phase 2 dose) that can be given in this patient population.

NCT ID: NCT03182244 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation

A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

Start date: January 15, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study will evaluate safety as well as determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.