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Preleukemia clinical trials

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NCT ID: NCT00611351 Completed - Lymphoma Clinical Trials

Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer

Start date: June 7, 2005
Phase: Phase 2
Study type: Interventional

RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.

NCT ID: NCT00607997 Completed - Leukemia Clinical Trials

Study of Voreloxin in Older Patients With Untreated Acute Myeloid Leukemia

Start date: April 2008
Phase: Phase 2
Study type: Interventional

This study will evaluate the overall remission rate of treatment with voreloxin Injection in patients at least 60 years of age with previously untreated AML

NCT ID: NCT00606437 Completed - Lymphoma Clinical Trials

Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants

Start date: September 2005
Phase: Phase 1
Study type: Interventional

Results to date of umbilical cord blood transplantation in adult and fully mature adolescent patients are inferior to what is seen in children, due to a lower stem cell dosage in adults and a more toxic conditioning regimen. This phase 1 protocol will use a potentially less toxic bone marrow conditioning regimen, followed by infusion of a combined umbilical cord blood graft that will provide the patient with a higher stem cell dose than can be given with a single umbilical cord blood infusion. The subjects will be conditioned with a total body irradiation (TBI) 13.5 Gy and fludarabine. Following conditioning, up to two unrelated, partially matched umbilical cord blood grafts will be infused that will provide a minimum nucleated cell dose of 3 x 10e7/kg . The primary objective of this study is to measure the frequency of treatment-related toxicity and engraftment.

NCT ID: NCT00606216 Completed - Clinical trials for Acute Myeloid Leukemia

Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy

Start date: January 2007
Phase: N/A
Study type: Observational

The purpose of this study is to learn about possible changes in brain anatomy and in thinking abilities, such as memory skills, in patients with cancer who receive treatment with chemotherapy alone or in combination with total body radiation before undergoing stem cell transplantation.

NCT ID: NCT00604201 Completed - Clinical trials for Severe Aplastic Anemia (SAA)

Stem Cell Transplant Using Peripheral and Cord Blood Stem Cells to Treat Severe Aplastic Anemia and Myelodysplastic Syndrome

Start date: May 21, 2008
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and effectiveness of treating patients with severe aplastic anemia (SAA) or myelodysplastic syndrome (MDS) with both peripheral blood stem cells from a family member and umbilical cord blood stem cells from an unrelated donor. Patients with SAA or MDS for whom other treatments have failed or are not available may be eligible for this study. Candidates may not have a tissue-matched sibling or matched unrelated donor and must have a family member who is a partial tissue type match. Participants undergo the following tests and procedures: - Insertion of a central intravenous (IV) line (plastic tube) into a large vein. The tube is used for giving the donated stem cells and antibiotics and other medicines, for transfusions of red blood cells and platelets, and for collecting blood samples. - Preparatory chemotherapy (fludarabine, cyclophosphamide and anti-thymocyte globulin) and total body irradiation to suppress immunity and prevent rejection of the donated cells. - Infusion of the donated stem cells and umbilical cord cells. - Immune suppression with the drugs tacrolimus, mycophenolate mofetil and prednisone to prevent rejection of the donated cells and to prevent graft-versus-host disease (GVHD), a complication of stem cell transplants in which the donors immune cells destroy the patients healthy tissues. The average hospital stay after stem cell transplantation is 3 to 4 weeks. Patients return for frequent follow-up visits for the first 2 to 4 months after transplantation. Once the patient returns home, his or her referring physician is asked to send results of any laboratory testing to the NIH researchers at least every 3 months for the first 3 years and annually thereafter. Patient follow-up visits are scheduled at NIH at 1, 2, 3, 4 and 5 years after transplantation to monitor for signs of disease or post-transplantation complications, such as infection or GVHD. After 5 years, participants are offered the opportunity to enroll in NHLBIs long-term evaluation and follow-up care protocol.

NCT ID: NCT00602771 Completed - Clinical trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia

Start date: January 2008
Phase: Phase 2
Study type: Interventional

This randomized phase II trial is studying the side effects and how well giving tipifarnib together with etoposide works in treating older patients with newly diagnosed, previously untreated acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer cells.

NCT ID: NCT00602693 Completed - Multiple Myeloma Clinical Trials

T-Regulatory Cell Infusion Post Umbilical Cord Blood Transplant in Patients With Advanced Hematologic Cancer

Start date: July 23, 2007
Phase: Phase 1
Study type: Interventional

RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood transplant helps stop the patient's immune system from rejecting the donor's stem cells. 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-regulatory cells after the transplant may decrease this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. However, the donor immune system may also react against the recipient's tissues (graft-versus-host disease). PURPOSE: This phase I trial is studying the side effects and best dose of donor T-regulatory cells after an umbilical cord blood transplant in treating patients with advanced hematologic cancer or other disorder.

NCT ID: NCT00597714 Completed - Leukemia Clinical Trials

Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant

Start date: February 2008
Phase: Phase 2
Study type: Interventional

The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free, and overall survival rates in patients treated with alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.

NCT ID: NCT00597519 Completed - Cancer Clinical Trials

A Myeloablative Conditioning Regimen and Total Body Irradiation Followed by the Transplantation for Patients With Hematological Malignancy

Start date: March 2006
Phase: Phase 2
Study type: Interventional

In this study two cord blood collections will be used to increase the number of cord blood cells you will receive on transplant day. We call this a "double unit" cord blood transplant. A previous study suggests double unit cord blood transplant may have a better result. The main purpose of this study is to find out how good a cord blood transplant using two cord blood collections from two different babies is at curing you of your cancer. Double unit cord blood transplants are now being studied as a way to increase the number of cord blood cells given to bigger children and adult patients. Based on studies that have already been done double unit cord blood transplant appears to be safer than if only one cord blood unit is used. However, double unit cord blood transplant is a fairly new form of treatment.

NCT ID: NCT00592046 Completed - Multiple Myeloma Clinical Trials

A Phase I Trial of ZIO-101 in Hematologic Cancers

Start date: May 2005
Phase: Phase 1
Study type: Interventional

This study uses a new investigational (not yet approved by the FDA for widespread use) drug called ZIO-101, an organic arsenical. You must be diagnosed to have relapsed/refractory leukemia or lymphoma (blood cancer) and have tried other standard therapies. This study is designed to determine whether ZIO-101 may be given safely. The study will also test whether ZIO-101 helps to treat blood cancer. We anticipate that approximately 22 to 35 patients will take part in this study. Arsenic has been used as a medicinal agent for centuries in many different cultures. Most recently in the United States, an inorganic arsenic compound was approved by the FDA for the treatment of patients with relapsed acute promyelocytic leukemia (APL). However, use of inorganic arsenic is limited by a narrow range of activity and systemic toxicity, most notably of the cardiac system. ZIO-101 is an organic arsenic derivative. In vitro testing in both the National Cancer Institute (NCI) cancer cell panel and in vivo testing in a leukemia animal model demonstrated substantial activity of SGLU against hematologic cancers. In vitro testing of SGLU using the NCI human cancer cell panel also detected activity against lung, colon and brain cancers, melanoma, and ovary and kidney cancers. Moderate activity was seen against breast and prostate cancers cells. Data suggest that organic arsenic generates reactive oxygen species in the cells to induce apoptosis and cell cycle arrest.