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Leukemia, Myeloid clinical trials

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NCT ID: NCT03839446 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy

Start date: February 28, 2019
Phase: Phase 2
Study type: Interventional

This study is an open-label, single arm phase II study which will examine the efficacy and toxicity of the combination therapy of GO, mitoxantrone and etoposide in patients who did not respond to first line induction therapy.

NCT ID: NCT03836209 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

Start date: December 6, 2019
Phase: Phase 2
Study type: Interventional

Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation. Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation. Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective. Gilteritinib has been approved by the Food and Drug Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is considered investigational. Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML. The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving combination chemotherapy for FLT3 AML.

NCT ID: NCT03772925 Active, not recruiting - Clinical trials for Refractory Acute Myeloid Leukemia

Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Start date: June 20, 2019
Phase: Phase 1
Study type: Interventional

This phase I trial studies side effects and best dose of pevonedistat and belinostat in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as pevonedistat and belinostat, 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.

NCT ID: NCT03761914 Active, not recruiting - Colorectal Cancer Clinical Trials

Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers

Start date: June 28, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and tolerability of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers. Patients will be followed long-term for Overall Survival (OS) and safety. The study will enroll approximately 90 patients and maximum study treatment duration is approximately 2.13 years.

NCT ID: NCT03755414 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

Start date: September 4, 2019
Phase: Phase 1
Study type: Interventional

In this trial, the investigators will begin to explore the possibility that, as in mice, janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release syndrome (CRS) while retaining Graft-versus-Leukemia (GVL) and improving engraftment. The purpose of this pilot study is to determine the safety of itacitinib with haplo-hematopoietic cell transplantation (HCT) measured by the effect on engraftment and grade III-IV GVHD.

NCT ID: NCT03747757 Active, not recruiting - Lymphoma Clinical Trials

Cognitive Behavioral Therapy in Helping Patients With Acute Myeloid Leukemia or Lymphoma With Cancer-Related Fatigue

Start date: November 29, 2018
Phase: Phase 2
Study type: Interventional

This 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.

NCT ID: NCT03746054 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia (CML)

Evaluation of a Cardiovascular Active Prevention in Chronic Myeloid Leukemia on the Cardiovascular Morbi-mortality

PALERMO
Start date: December 20, 2019
Phase: Phase 3
Study type: Interventional

According to the French National Cancer Institute, 35 000 new hematologic cancers are observed in France representing 10% of the new cancers. Chronic Myeloid Leukemia (CML) is a cancer involving the bone marrow and blood cells, the median age at diagnosis is 53 years in the Western world. The prognosis is worse than many other cancers with net survival at 5 years of 26%. Since the approval of imatinib, additional tyrosine kinase inhibitors (TKIs) have been approved by the European Medicine Agency, including the second-generation TKIs nilotinib, dasatinib, and bosutinib and the third-generation TKI ponatinib. Despite their effect on the evolution of CML, there is increasing of cardiovascular toxicities which can impact patient morbidity and mortality. The majority of the cardiovascular toxicities are associated with the second- and third-generation TKIs. Nilotinib and ponatinib cardiovascular toxicity including arterial and venous thromboembolism has decrease the benefit/risk ratio, 10% of patients treated with nilotinib 300 mg twice daily and 15.9% treated with 400 mg twice daily experienced a vascular complication including myocardial infarction /ischemic heart disease, cerebrovascular accidents, or peripheral arterial disease. Regarding ponatinib, serious arterial occlusive adverse reactions occurred in 19% of patients. In an attempt to reduce major adverse cardiovascular events MACE due to nilotinib and ponatinib, currently, then approach is driven by usual clinical practice without any robust published evidence. The investigators aim to perform a national clinical trial, multicenter, prospective, randomized, with two parallel comparative arms: experimental group with cardiovascular active prevention vs non active cardiovascular active prevention based on usual clinical practice. Our hypothesis is that active prevention of cardiovascular toxicities with optimal medical treatment improves the benefit-risk ratio in CML patients. The primary objective is Event Free Survival (EFS) at month 24.

NCT ID: NCT03722420 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia, Chronic Phase

Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)

Start date: December 28, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase III, multi-center, open-label, parallel, 2-arm, randomized study to evaluate the efficacy and safety of radotinib 300 mg Bis In Die(BID) versus imatinib 400 mg Quaque Die(QD). This study will be conducted in Chinese patients with newly diagnosed Ph+ Chronic Myelogenous Leukemia(CML)-Chronic Phase(CP) who are previously untreated for Chronic Myelogenous Leukemia(CML).

NCT ID: NCT03697707 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia in Remission

Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia

ADVANCE-II
Start date: October 15, 2018
Phase: Phase 2
Study type: Interventional

Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD

NCT ID: NCT03690115 Active, not recruiting - Clinical trials for Leukemia, Myeloid, Acute

Study of Ponatinib (Iclusig) for Prevention of Relapse After Allogeneic Stem Cell Transplantation (Allo-SCT) in FLT3-ITD AML Patients

PONALLO
Start date: December 2, 2019
Phase: Phase 2
Study type: Interventional

Recent advances in acute myeloid leukemia (AML) have been characterized by a better understanding of disease biology. As such, FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) have been recognized as conferring a poor prognosis. The FLT3-ITD molecular mutation is observed in about one-quarter of patients diagnosed with AML. Patients presenting with this abnormality are referred for early allogeneic stem-cell transplantation (allo-SCT). However, some data suggest that FLT3-ITD remains associated with a poor prognosis even after allo-SCT because of higher risk of relapse and strategies for preventing relapse in the post-transplant setting are required (Hu et al, Expert Rev Hematol, 2014). For example, in a large cohort of patients (Brunet et al, JCO, 2012), the incidence of relapse for FLT3-ITD AML patients after allo-SCT was 30% at 2-years, significantly higher compared to FLT3-ITD negative patients (p=0.006). Ponatinib (Iclusig®) is an orally available, tyrosine kinase inhibitor with a unique binding mechanism allowing inhibition of BCR-ABL kinases, including those with the T315I point mutation. Ponatinib also has in vitro inhibitory activity against a discrete set of kinases implicated in the pathogenesis of other hematologic malignancies, including FLT3, KIT, fibroblast growth factor receptor 1 (FGFR1), and platelet derived growth factor receptor α (PDGFRα). In vitro activity of ponatinib in AML has been already demonstrated (Gozgit et al, Mol Cancer Ther, 2011; Smith et al, Blood 2013). If some trials are on-going to test ponatinib alone or in combination with chemotherapy in FLT3-ITD AML (Clinical.trials.gov), no study is dedicated to the use of ponatinib in the post-transplant setting in order to prevent relapse in these patients. The main goal of this study will be to determine the maximal tolerated dose (MDT) of ponatinib after allo-SCT in FLT3-ITD AML patients, then to investigate the efficacy of ponatinib in a larger cohort of patients