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NCT ID: NCT00580034 Completed - Lymphoma Clinical Trials

Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath

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

Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though the potential toxicities of the procedure remain high. We and others have shown that a less toxic preparative regimen allows reliable allogeneic engraftment for allogeneic transplantation. The primary purpose of this treatment trial is to follow patients undergoing allogeneic transplantation for long term outcomes. The regimen used has been tested in our prior phase I / II trial which has completed accrual. The issues of engraftment and rate of graft versus host disease have been answered and our success has led to this regimen being a standard approach for less toxic allogeneic therapy.

NCT ID: NCT00579917 Completed - Multiple Myeloma Clinical Trials

Behavioral Intervention For BMT/SCT Survivors

BMT/SCT
Start date: January 2005
Phase: N/A
Study type: Observational

The purpose of this study is to understand how to help survivors of bone marrow transplant and stem cell transplant (BMT/SCT) with emotional distress. BMT/SCT has become a more common type of treatment for cancer or hematological disorder (blood disease). For this reason, there is concern that adjustment after treatment may be difficult for many persons. We have found that about 25% of BMT/SCT survivors still feel anxious and distressed about their illness and its treatment after at least one year following transplant. This study is one of the first to study the impact of counseling on BMT/SCT survivors. The study is being carried out at Memorial Sloan-Kettering Cancer Center, Mount Sinai Medical Center, and Hackensack University Medical Center.

NCT ID: NCT00579163 Active, not recruiting - Leukemia Clinical Trials

Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers

Start date: December 1994
Phase:
Study type: Observational

The purpose of this study is to better understand the genetic causes of cancer and the inherited tendency to develop cancer. To accomplish this, blood specimens and/or saliva samples and/or tumor and normal tissue blocks from patients and families of patients with cancer will be collected. Blood specimens will be frozen and stored for analysis at a later date. Tumor tissue and normal tissue will be stored for analysis at a later date. In order to perform this study, patients and members of their families will be asked to provide blood samples and/or saliva samples. Individuals will be asked to provide a history of cancer in their relatives at the time the blood sample is given. No relatives will be contacted before they have been asked by a family member if they wish to participate in this study. If they do wish to participate, the relatives should indicate this by returning the "Family Member Consent for Contact Form" After we receive this form, arrangements may be made for the family member to send in a blood and/or saliva sample or to come in person to provide the sample to us. Except for family history, no medical information provided by one member of a family will be discussed with other family members. At the end of this form, we will also ask for your permission to be contacted in the future to discuss information about your health, additional research with your samples and/or certain research findings possibly related to your sample.

NCT ID: NCT00579111 Terminated - Multiple Myeloma Clinical Trials

Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)

Start date: June 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are created in the bone marrow. They grow into different types of blood cells that the body needs, including red blood cells, white blood cells, and platelets. In a transplant, the body's stem cells would be killed and then replaced by stem cells from the donor. Usually, patients are given very high doses of chemotherapy (drugs which kill cancer cells) prior to receiving a stem cell transplant. However, patients that are older, have received several prior treatments, or have other organ diseases are at a high risk of getting life-threatening treatment-related side effects from high doses of chemotherapy. Over the past several years, some doctors have begun to use lower doses of chemotherapy for preparing patients for a stem cell transplant. A condition that can occur after a stem cell transplant from a donor is Graft Versus Host Disease (GVHD). It is a rare but serious disorder that can strike persons whose immune system is suppressed and have received either a blood transfusion or a bone marrow transplant. Symptoms may include skin rash, intestinal problems similar to inflammation of the bowel and liver dysfunction. This research study uses a combination of lower-dose chemotherapy agents that is slightly different from those that have been used before. The medicines that will be used in this study are Fludarabine, Busulfan, both chemotherapy medicines, and Campath. Campath is a monoclonal antibody (a type of substance produced in the laboratory that binds to cancer cells). It helps the immune system see the cancer cell as something that needs to be destroyed. This research study will help us learn if using Fludarabine, Busulfan and Campath prior to an allogeneic stem cell transplant can provide treatment for blood disorders while decreasing the incidence of side effects.

NCT ID: NCT00578942 Completed - Lymphoma Clinical Trials

Allo Non-myeloablative SCT Utilizing Matched Family Member Stem Cells Purged Using Campath

Start date: May 2005
Phase: Phase 2
Study type: Interventional

Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though the potential toxicities of the procedure remain high. We and others have shown that a less toxic preparative regimen allows reliable allogeneic engraftment for allogeneic transplantation. The primary purpose of this treatment trial is to follow subjects undergoing allogeneic transplantation for long term outcomes. The regimen used has been tested in our prior phase I / II trial which has completed accrual. The issues of engraftment and rate of graft versus host disease have been answered and our success has led to this regimen being a standard approach for less toxic allogeneic therapy.

NCT ID: NCT00578539 Terminated - Leukemia Clinical Trials

T-Reg Cell Kinetics, Stem Cell Transplant, REGALE

REGALE
Start date: October 2007
Phase: N/A
Study type: Interventional

Patients have a type of blood cell disorder that is very hard to cure. We are now suggesting a treatment that might help patients live longer without disease than other treatment plans would. This treatment is known as a stem cell transplant. We believe this may help patients as it allows us to give much stronger doses of drugs and radiation to kill the diseased cells than we could give without the transplant. We also think that the healthy cells may help fight any diseased cells left after the transplant. Stem Cells are special "mother" cells that are found in the bone marrow (the spongy tissue inside bones), although some are also found in the bloodstream (peripheral blood). As they grow, they become either white blood cells which fight infection, red blood cells which carry oxygen and remove waste products from the organs and tissues or platelets, which enable the blood to clot. For the transplant to take place, we will collect these stem cells from a "donor" (a person who agrees to donate these cells) and give them to recipient. Patients do not have a sibling that is a perfect match, so the stem cells will come from a donor who is the best match available. This person may be a close relative or an unrelated person whose stem cells best "matches" the patients, and who agrees to donate stem cells. Before the transplant, two very strong drugs plus total body irradiation will be given to the patient (pre-conditioning). This treatment will kill most of the blood-forming cells in the bone marrow. We will then give the patient the healthy stem cells. Once these healthy stem cells are in the bloodstream they will move to the bone marrow (graft) and begin producing blood cells that will eventually mature into healthy red blood cells, white blood cells and platelets. This research study will also use CAMPATH-1H as a pre-treatment. CAMPATH-1H is an antibody against certain types of blood cells. CAMPATH-1H is important because it stays active in the body for a long time after infusion, which means it may work longer at preventing GvHD symptoms. The stem cell transplant described above is considered to be "standard" treatment. We would like to collect additional blood as described below in order to evaluate how the immune system is recovering. We are asking permission to draw blood from the patient so that we can measure the number of certain blood cells called T regulatory cells. T regulatory cells are special immune cells that can control or regulate the body's immune response. We want to determine whether T regulatory cells are important participants in graft versus host disease (GVHD), infection and relapse. In GVHD, certain cells from the donated marrow or blood (the graft) attack the body of the transplant patient (the host). GVHD can affect many different parts of the body. The skin, eyes, stomach and intestines are affected most often. GVHD can range from mild to life-threatening. We do not know whether T regulatory cells can modify these conditions. We want to measure these T regulatory cells and learn if these cells do influence these conditions. If we learn that T regulatory cells do affect these conditions, then it may be possible to modify these cells for the benefit of transplant patients.

NCT ID: NCT00578461 Terminated - Cancer Clinical Trials

T-Regulatory Cell Kinetics, Stem Cell Transplantation, REGKINE

REGKINE
Start date: October 2007
Phase: N/A
Study type: Interventional

Patients are being asked to participate in this study because they have a cancer in their blood (such as leukemia or lymphoma) or myelodysplastic/myeloproliferative (pre-leukemia). We suggest a treatment that might help them live longer without disease than other treatment plans would. This treatment is known as a stem cell transplant. We believe this may help the patient as it allows us to give much stronger doses of drugs and radiation to kill the diseased cells than we could give without the transplant. We also think that the healthy cells may help fight any diseased cells left after the transplant. Stem Cells are special "mother" cells that are found in the bone marrow (the spongy tissue inside bones), although some are also found in the bloodstream (peripheral blood). As they grow, they become either white blood cells which fight infection, red blood cells which carry oxygen and remove waste products from the organs and tissues or platelets, which enable the blood to clot. For the transplant to take place, we will collect these stem cells from a "donor" (a person who agrees to donate these cells) and give them to the patient. The patient has a type of blood cell cancer or other blood problem that is very hard to cure with standard treatments and they will receive a stem cell transplant (SCT). If they have a brother or sister that is a perfect match and agrees to donate, the stem cells will come from him/her. Before the transplant, two very strong drugs plus total body irradiation will be given to the patient (pre-conditioning). This treatment will kill most of the blood-forming cells in the bone marrow. We will then give the patient the healthy stem cells. Once these healthy stem cells are in the bloodstream they will move to the bone marrow (graft) and begin producing blood cells that will eventually mature into healthy red blood cells, white blood cells and platelets. Also, we will ask permission to draw blood from the patient so that we can measure the number of certain blood cells called T regulatory cells. T regulatory cells are special immune cells that can control or regulate the body's immune response. We want to determine whether T regulatory cells are important participants in graft versus host disease (GVHD), infection and relapse. In GVHD, certain cells from the donated marrow or blood (the graft) attack the body of the transplant patient (the host). GVHD can affect many different parts of the body. The skin, eyes, stomach and intestines are affected most often. GVHD can range from mild to life-threatening. We do not know whether T regulatory cells can modify these conditions. We want to measure these T regulatory cells and learn if these cells do influence these conditions. If we learn that T regulatory cells do affect these conditions, then it may be possible to modify these cells for the benefit of transplant patients.

NCT ID: NCT00577694 Terminated - Leukemia Clinical Trials

Clofarabine and Gemtuzumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Start date: November 2007
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving clofarabine together with gemtuzumab may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with gemtuzumab in treating patients with relapsed or refractory acute myeloid leukemia.

NCT ID: NCT00577278 Completed - Lymphoma Clinical Trials

A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan

Start date: October 3, 2007
Phase: Phase 2
Study type: Interventional

RATIONALE: Giving monoclonal antibody therapy, radioimmunotherapy, and chemotherapy before a donor 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 the stem cells from a related donor that do not exactly match the patient's blood, 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 also make an immune response against the body's normal cells. Giving tacrolimus and sirolimus before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and how well giving indium In 111 ibritumomab tiuxetan and yttrium y 90 ibritumomab tiuxetan together with rituximab, fludarabine, melphalan, and donor stem cell transplant works in treating patients with B-cell non-Hodgkin lymphoma.

NCT ID: NCT00576979 Active, not recruiting - Leukemia Clinical Trials

Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Start date: March 4, 2008
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as etoposide and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. It also helps 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. Giving IMRT together with chemotherapy before transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy (IMRT) when given together with etoposide and cyclophosphamide followed by donor stem cell transplant and to see how well they work in treating patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).