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Preleukemia clinical trials

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NCT ID: NCT01885897 Completed - Lymphoma Clinical Trials

IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT

Start date: November 11, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, phase I/II clinical trial for patients who have relapsed more than 60 day after allogeneic transplant for a hematologic malignancy. The study consists of two phases. The dose finding phase is a modified version of a phase I trial and the extended phase is a modified version of a phase II trial. The primary objective of the dose finding phase is to determine the maximum tolerated, minimum efficacious dose (MTD/MED) of a interleukin-15 (IL-15) super agonist complex (ALT-803) when given once weekly for 4 weeks in the outpatient setting. The study will follow a standard 3+3 design of dose escalation for toxicity with an added feature of stopping early if efficacy is confirmed. There are six dose levels of ALT-803 for to determine the MTD/MED: 1, 3, 6, 10, 20, and 30 mcg/kg. Once the MTD/MED for ALT-803 is determined, this cohort will be used in the extended phase. The primary goal of this extended phase is to study the potential efficacy of ALT-803 in this patient population. Efficacy will be measured using rates of remission induction. An optimal Simon's two-stage design will be used in this phase. Stage 1 will enroll 14 patients (including the 6 patients treated at the MTD/MED during the dose finding phase). If 3 or more of these 14 patients respond to ALT-803, the trial will move to stage 2 and enroll an additional 23 patients. If 2 or fewer respond, the study will terminate enrollment early.

NCT ID: NCT01873703 Completed - Clinical trials for Myelodysplastic Syndrome

Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome

Start date: June 2013
Phase: Phase 2
Study type: Interventional

The purpose of this randomized, double-blind, placebo-controlled study is to determine the safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and FDA approved treatment for Myelodysplastic Syndrome (MDS).

NCT ID: NCT01872819 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay

Start date: August 2, 2013
Phase: N/A
Study type: Interventional

This clinical trial uses a laboratory test called a high throughput sensitivity assay in planning treatment for patients with relapsed or refractory acute myeloid leukemia. The aim is to try to identify drugs that may be effective in killing leukemia cells for those patients who will not be cured with conventional chemotherapy. This assay will test multiple drugs simultaneously against a patient's own donated blood sample. The goal is to use this laboratory assay to best match a drug to a patient's disease.

NCT ID: NCT01868477 Completed - Clinical trials for Low and Int 1-risk Myelodysplastic Syndrome

Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

Start date: January 28, 2014
Phase: Phase 2
Study type: Interventional

The primary purpose of this trial was is to assess the effect of treatment with deferasirox combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low- and int-1-risk myelodysplastic syndrome. The addition of deferasirox to erythropoietin can lead to a potential synergism with the reduction of reactive oxygen species, through both the NF-kB pathway and the control of free toxic iron. This may create a better environment in the bone marrow for a better response with erythropoietin. This study was designed to test in a prospective way the combination of deferasirox with erythropoietin in terms of their effect on hematopoiesis.

NCT ID: NCT01866839 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Preventing Stem Cell Transplant Complications With a Blood Separator Machine

Start date: May 29, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Researchers are working to make stem cell transplant procedures safer and more effective. One complication of transplants is graft-versus-host disease (GVHD). This complication happens when certain white blood cells from the donor attack the recipient's own body. Researchers want to test a blood separator machine that may help remove more of the donor's white blood cells before transplant. They will study donors and recipients during stem cell transplant to see how well this process can prevent GVHD and other complications. Objectives: - To see if a new blood separator machine can improve outcomes of stem cell transplants. Eligibility: - Individuals between 10 and 75 years of age who are having a stem cell transplant for leukemia or other blood-related cancers. - Donors for the stem cell transplant. Design: - Recipients and donors will be screened with a physical exam and medical history. - Donors will have two blood collection procedures. The first will collect only white blood cells, and return the rest of the blood. After the first collection, participants will have filgrastim injections to help their stem cells enter their blood. Then, they will have a second blood collection for the stem cells. - Recipients will have radiation and chemotherapy to prepare for the stem cell transplant. They will then have the stem cell transplant with the donor cells that have been treated with the blood separator machine. - Recipients will be monitored closely after the procedure. They may receive some of their donor's white blood cells if needed to fight serious infections. - Recipients will have the regular standard of care after their transplant. Blood samples will be taken and any side effects will be monitored and treated.

NCT ID: NCT01858740 Completed - Clinical trials for Recurrent Adult Acute Myeloid Leukemia

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children

Start date: April 10, 2014
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well T cell depleted donor peripheral blood stem cell transplant works in preventing graft-versus-host disease in younger patients with high risk hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing a subset of the T cells from the donor cells before transplant may stop this from happening.

NCT ID: NCT01855698 Completed - Multiple Myeloma Clinical Trials

PENELOPE Observational Study: Prophylaxis and Treatment of Arterial and Venous Thromboembolism

Start date: June 2013
Phase:
Study type: Observational

The primary objective of the study is to assess efficacy and safety of different prophylactic or therapeutic antithrombotic approaches in patients with hematologic neoplasms and platelet count <50 x109/L, including unfractionated or low molecular weight heparin, fondaparinux, anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants, fibrinolytic agents, with or without a policy of platelet transfusion. Cases with arterial or venous thromboembolism managed with observation or use of vena cava filters in patients with venous thromboembolism will be included too.

NCT ID: NCT01842646 Completed - Clinical trials for Myelodysplastic Syndrome (MDS)

Phase II Hedgehog Inhibitor for Myelodysplastic Syndrome (MDS)

Start date: August 29, 2013
Phase: Phase 2
Study type: Interventional

This study is being done to see how safe an investigational drug is and test how well it will work to help people with refractory/relapsed myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).

NCT ID: NCT01839916 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Start date: April 4, 2013
Phase: Phase 2
Study type: Interventional

This pilot phase II trial studies how well giving donor T cells after donor stem cell transplant works in treating patients with hematologic malignancies. In a donor stem cell transplant, the donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect.

NCT ID: NCT01835587 Completed - Clinical trials for Myelodysplastic Syndromes

Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).

Start date: October 25, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic stem cell transplant (HSCT). HSCT is more frequently used in AML or MDS as a potential curative therapy. However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the principal causes of fatal complications after transplantation. Oral azacitidine has significant activity in MDS and AML. Oral azacitidine has also demonstrated immunomodulatory activity in AML patients after allogeneic HSCT. An oral formulation of oral azacitidine provides a convenient route of administration and an opportunity to deliver the drug over a prolonged schedule.