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Myelodysplastic Syndromes clinical trials

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NCT ID: NCT00065143 Completed - Clinical trials for Myelodysplastic Syndromes

Clofarabine Plus Cytarabine in Patients With Previously Untreated Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome

Start date: June 23, 2003
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if clofarabine, when given in combination with ara-C (cytarabine), can help to improve the disease's response to therapy and to increase the duration of response in patients who are 50 years or older with leukemia. The safety of this combination treatment will also be studied.

NCT ID: NCT00064974 Completed - Clinical trials for Myelodysplastic Syndromes

Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

Start date: June 2003
Phase: Phase 2
Study type: Interventional

This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.

NCT ID: NCT00064584 Completed - Clinical trials for Myelodysplastic Syndrome

Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients With Acute Myelogenous Leukemia (AML)

Start date: May 2002
Phase: Phase 1
Study type: Interventional

This is the first study of the drug CT53518 when given to humans. The purpose of this study is to determine the highest dose of CT53518 that can safely be given to patients with Acute Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug. The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body. Additionally, the study will evaluate the effects of the drug on a specific type of cell in bone marrow and blood, known as a blast.

NCT ID: NCT00064376 Completed - Leukemia Clinical Trials

Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Start date: May 2003
Phase: Phase 2
Study type: Interventional

RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop into normal bone marrow cells. PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome.

NCT ID: NCT00064311 Completed - Breast Cancer Clinical Trials

Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transplantation

Start date: June 2003
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Antifungals such as ravuconazole may be effective in preventing fungal infections in patients undergoing chemotherapy and stem cell transplantation. PURPOSE: Phase I/II trial to study the effectiveness of ravuconazole in preventing fungal infections in patients undergoing allogeneic stem cell transplantation.

NCT ID: NCT00064090 Completed - Leukemia Clinical Trials

3-AP and Cytarabine in Treating Patients With Hematologic Cancer

Start date: March 2003
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and may help cytarabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining cytarabine with 3-AP in treating patients who have relapsed or refractory hematologic cancer.

NCT ID: NCT00062140 Completed - Lymphoma Clinical Trials

Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Start date: April 2003
Phase: Phase 1
Study type: Interventional

RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.

NCT ID: NCT00061763 Completed - Clinical trials for Myelodysplastic Syndromes

Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic Anemias

Start date: May 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effects of the oral iron chelator Deferasirox on liver iron content after one year of treatment in patients with iron overload from repeated blood transfusions. Beta-thalassemia patients unable to be treated with deferoxamine or patients with rare chronic anemias such as Myelodysplastic Syndrome, Fanconi's Syndrome, Blackfan-Diamond Syndrome, and Pure Red Blood Cell Anemia are eligible for this study. Liver iron content will be measured by liver biopsy at the beginning of the study and after one year of treatment. However, those patients living in the San Francisco/Oakland area may have a SQUID in place of the liver biopsy if the biopsy is not medically possible for them. The SQUID is a non-invasive magnetic means to measure liver iron content.

NCT ID: NCT00061581 Completed - Clinical trials for Myelodysplastic Syndromes

Experimental Bone Marrow Transplant Protocol

Start date: May 19, 2003
Phase: Phase 2
Study type: Interventional

Bone marrow transplantation (BMT) is a risky procedure. If doctors could reduce the complications, BMT would be safer to use for a wider range of conditions. The purposes of this study are - to prevent graft rejection by increasing the amount of immunosuppression and by giving some lymphocytes from the donor before transplant; - to prevent graft-versus-host disease (GVHD) by transplanting T-cell depleted stem cells; - to improve the immune effect against residual leukemia by the add-back of donor lymphocytes before transplant and six or more weeks after transplant. Beyond the standard transplant protocol, study participants will undergo additional procedures. First, along with total body irradiation, patients will receive two drugs (a high dose of cyclophosphamide and fludarabine) to suppress immunity and prevent rejection of the transplant. Second, four days before the transplant, patients will be given donor lymphocytes that have been irradiated to make them incapable of causing GVHD. On the day of the transplant, patients will receive an infusion of T-cell depleted bone marrow stem cells. Finally, patients will receive two doses of add-back donor T-cells (45 and 100 days post transplant) and the immunosuppressive drug cyclosporine starting on day 44 until about six months after transplant. Study participants must be between the ages of 10 and 56 and have a family member who is a suitable stem cell donor match.

NCT ID: NCT00060372 Completed - Clinical trials for Stage IV Breast Cancer

Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer

Start date: April 2003
Phase: Phase 1
Study type: Interventional

This phase I trial is studying how well ipilimumab works after allogeneic stem cell transplant in treating patients with persistent or progressive cancer. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.