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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT02236013 Completed - Clinical trials for Acute Myeloid Leukemia

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

Start date: January 7, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to describe the dose limiting toxicities (DLT) and define the maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin or daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of ASP2215 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of ASP2215 when given in combination with cytarabine/idarubicin or cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia as well as evaluate the effect of ASP2215 on the PK of cytarabine.

NCT ID: NCT02233504 Completed - Clinical trials for High Risk MDS or AML Patients

Pilot Study to Assess Hematologic Response in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndromes Undergoing Monotherapy With Exjade (Deferasirox)

Start date: August 2014
Phase: Early Phase 1
Study type: Interventional

The purpose of this trial is to examine the hematologic response rate of Exjade® in patients with AML and high risk MDS and chronic iron overload from blood transfusions. Deferasirox has been developed as an iron-chelating agent, and unlike deferoxamine, a previously developed iron chelator, deferasirox has the advantage of oral administration.

NCT ID: NCT02226861 Completed - MDS Clinical Trials

Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation

Start date: August 26, 2014
Phase: Phase 1
Study type: Interventional

Background: - Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations. Objective: - To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD. Eligibility: - Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an available family member with partial tissue match. - Donors: age 18 80. Design: - Recipients will be screened with medical history, physical exam, and many tests including blood and tissue tying. - Donors will be screened with medical history, physical exam, blood tests and tissue typing. - Recipients will stay in the hospital 3 6 weeks. - All participants will have apheresis. Blood is drawn from one arm, run through a machine that collects white blood cells, then returned into the other arm. - Recipients will have: - Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout transplant and recovery. They may also have a catheter inserted for collecting immune cells. - Bone marrow sample taken by needle. They will have 3 more after transplant. - Donors will have: - Filgrastim injected once daily for 5 6 days. - Stem and immune cells collected by another apheresis. - Recipients will get: - Eight 30-minute doses of radiation, sitting at a machine. - Donor immune cells by IV, 6 days before the transplant day. - Chemotherapy drugs by IV. <TAB><TAB>- Donor stem cells by IV on transplant day. - After transplant, recipients will give self-injections of very low doses of Interleukin-2 once daily for about 12 weeks. - Before and after transplant, recipients will get medicine to suppress the immune system and antibiotics to prevent infections - Recipients must stay near NIH for 3 6 months after transplant. - All recipients and donors will have 3 years of follow-up.

NCT ID: NCT02223052 Completed - Breast Cancer Clinical Trials

Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

Start date: October 27, 2014
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.

NCT ID: NCT02221310 Completed - Clinical trials for Myelodysplastic Syndrome

Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS

Start date: December 7, 2011
Phase: Phase 2
Study type: Interventional

Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy followed by allogeneic stem cell transplantation will be given to patients with high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).

NCT ID: NCT02212561 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome

Start date: August 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety of selinexor (KPT-330) and to find the highest dose of selinexor (KPT-330) that can be given safely when it is combined with two chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase I and Phase II. The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we can give to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine. The goal of the subsequent Phase II portion of the study (insert NCT ID of SELHEM-2) is to give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for children with leukemia or MDS. The investigators will examine the effect of this combination treatment. PRIMARY OBJECTIVE: - Determine a tolerable combination of selinexor, fludarabine, and cytarabine in pediatric patients with relapsed or refractory hematologic malignancies included acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia (MPAL) and myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: - To characterize the pharmacokinetics of selinexor, when administered in tablet form, after the first dose and at steady-state, as well as in combination with fludarabine and cytarabine - To estimate the overall response rate of selinexor given with fludarabine and cytarabine in patients with relapsed or refractory hematologic malignancies

NCT ID: NCT02203825 Completed - Multiple Myeloma Clinical Trials

Safety Study of Chimeric Antigen Receptor Modified T-cells Targeting NKG2D-Ligands

Start date: March 2015
Phase: Phase 1
Study type: Interventional

This Phase I clinical trial is evaluating chimeric-antigen receptor (CAR) T-cells (CM-CS1 T cells) which recognize NKG2D-ligands on the surface of cancer cells. This study evaluates the safety and feasibility of administering a single intravenous dose of CM-CS1 CAR T-cells to patients with AML, MDS-RAEB and Multiple Myeloma.

NCT ID: NCT02197676 Completed - MDS Clinical Trials

A Phase II Trial of SGI-110 in Patients With IPSS High and Int 2 Myelodysplastic Syndrome, Acute Myeloid Leukemia With 20-30% Marrow Blasts or Chronic Myelomonocytic Leukemia Type 2 Not Responding to Azacitidine or Decitabine After at Least 6 Courses or Relapsing After a Response

Start date: August 4, 2014
Phase: Phase 2
Study type: Interventional

Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6 courses, or relapse after initial response.

NCT ID: NCT02196857 Completed - Leukemia Clinical Trials

Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation

Start date: February 6, 2015
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help to control the disease in patients with Acute Myeloid Leukemia (AML) and high risk Myelodisplastic Syndrome (MDS) with FLT3-ITD mutation. The safety of this drug combination will also be studied.

NCT ID: NCT02190695 Completed - Clinical trials for Acute Myeloid Leukemia

Leukemia SPORE Phase II DAC Study for R/R and Elderly Acute AML and MDS

Start date: April 1, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are used to treat AML and MDS but are not usually combined together. The investigators are looking at both the safety and Efficacy of each combination.