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Preleukemia clinical trials

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NCT ID: NCT01572662 Completed - Multiple Myeloma Clinical Trials

Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning

Start date: April 11, 2012
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if giving busulfan and fludarabine before a stem cell transplant can help control the disease better than the standard method in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses of busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of busulfan and fludarabine during the week before the stem cell transplant, rather than the standard method of giving 4 doses of busulfan and fludarabine only during the week before the stem cell transplant. The safety of this combination therapy will also be studied. Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants. Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer cells to die.

NCT ID: NCT01571648 Completed - Clinical trials for Myelodysplastic Syndromes

A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Patients With Myelodysplastic Syndromes

Start date: April 1, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the tolerability of oral azacitidine in the treatment of patients with Myelodysplastic Syndromes (MDS).

NCT ID: NCT01567059 Completed - Clinical trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Tosedostat in Combination With Cytarabine or Decitabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Start date: May 2012
Phase: Phase 2
Study type: Interventional

This study examines a new oral chemotherapy drug called tosedostat, in combination with cytarabine or decitabine. Tosedostat is thought to work by decreasing the availability of amino acids (building blocks the cell needs to make proteins) in cells. It has been shown in early studies to have activity against a variety of cancers, including leukemias. Patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with specific genetic mutations have a poorer response to chemotherapy and a higher risk of relapse after treatment. Researchers are looking to see if combinations of chemotherapy drugs may improve outcomes for patients that do not respond as well with the current chemotherapy regimens, without increasing the risks of treatment.

NCT ID: NCT01566695 Completed - Clinical trials for Myelodysplastic Syndrome

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

Start date: April 26, 2013
Phase: Phase 3
Study type: Interventional

Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

NCT ID: NCT01546038 Completed - Clinical trials for Acute Myeloid Leukemia

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Start date: June 27, 2012
Phase: Phase 2
Study type: Interventional

This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.

NCT ID: NCT01542944 Completed - Clinical trials for Acute Myeloid Leukemia

TevaGastrim for Stem Cell Mobilization Sibling Donors

Start date: February 2012
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation.

NCT ID: NCT01541280 Completed - Clinical trials for Acute Myeloid Leukemia

VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

VIDAZA-DLI
Start date: November 2011
Phase: Phase 2
Study type: Interventional

Patients included in the study with high risk acute myeloid leukemia or myelodysplastic syndrome as defined will receive an allogeneic transplantation conditioned by either myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with donor lymphocyte infusion.

NCT ID: NCT01529827 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Start date: February 28, 2012
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the 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 cell from a donor can make an immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and methotrexate after transplant may stop this from happening

NCT ID: NCT01519011 Completed - Clinical trials for Myelodysplastic Syndromes

Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine

Start date: February 7, 2012
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine when administered once daily as two 150-mg tablets, including the effect of food, and to evaluate the bioavailability of oral azacitidine 300-mg when administered as two 150-mg tablets relative to three 100-mg tablets.

NCT ID: NCT01517035 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Improving Blood Stem Cell Collection and Transplant Procedures

Start date: January 13, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - People who have some kinds of cancer can benefit from donated bone marrow stem cells. These stem cells help produce healthy bone marrow and slow or stop the spread of abnormal cells. However, stem cells transplants do not always work. Also, they may have serious side effects that can cause illness or death. The Bone Marrow Stem Cell Transplant Program is studying methods to make stem cell transplant procedures safer and more effective. Objectives: - To test a new procedure that may improve the success and decrease the side effects of stem cell transplants. Eligibility: - Individuals 10 to 75 years of age who have a life-threatening illness that may require a stem cell transplant. - Healthy siblings who are able to provide stem cells for transplant. Design: - Participants will be screened with a medical history, physical exam, and blood and urine tests. - Donor procedures: - Stem cell donors will start by having apheresis to donate white blood cells. - Donors will receive filgrastim shots for 5 days to help move stem cells into the blood for collection. - Donors will have another round of apheresis to donate the stem cells for transplant. - Recipient procedures: - Before the transplant, recipients will have radiation twice a day for 3 days and chemotherapy for 7 days. - After the radiation and chemotherapy, recipients will receive the stem cells provided by the donor. - After the transplant, recipients will receive the white blood cells provided by the donor. - Recipients will be monitored closely for 4 months to study the success of the transplant. They will have more followup visits at least yearly thereafter. - Recipients will have a research apheresis prior to transplant and at 3 months.