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Leukemia clinical trials

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NCT ID: NCT00353860 Completed - Leukemia Clinical Trials

Stem Cell Transplantation and T-Cell Add-Back to Treat Bone Marrow Malignances

Start date: January 23, 2002
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and effectiveness of stem cell transplantation in which the donor s T cells (a type of lymphocyte, or white blood cell) have been removed and then added back. Certain patients with bone marrow malignancies undergo transplantation of donated stem cells (cells produced by the bone marrow that mature into the different blood components white cells, red cells and platelets) to generate new and normally functioning bone marrow. However, T-cells from the donor may see the patient s cells as foreign and mount an immune response to reject them, causing what is called graft-versus-host-disease (GVHD). Therefore, in this study, T-cells are removed from the donor cells to prevent this complication. Nevertheless, there are disadvantages of removing the T-cells, since they are important in fighting viral infections as well as any remaining malignant cells. The attack against the malignant cells is called a graft-versus-leukemia effect. Therefore, donor T cells are given to the patient (added back) later (45 and 100 days after the transplant) when they can provide needed immunity with less risk of causing GVHD. Patients between 10 and 55 years of age with chronic myelogenous leukemia, acute lymphoblastic leukemia, acute myelogenous leukemia, a myelodysplastic syndrome, myeloproliferative disorders, or chronic lymphocytic leukemia may be eligible for this study. Prospective participants and their donors are screened with a medical history and physical examination, blood tests (including a test to match for genetic compatibility), breathing tests, chest and sinus X-rays, and tests of heart function. They also undergo a bone marrow biopsy and aspiration. For this procedure, done under local anesthetic, about a tablespoon of bone marrow is withdrawn through a needle inserted into the hipbone. Participants may undergo apheresis to collect lymphocytes for research studies. This procedure involves collecting blood through a needle in the arm, similar to donating a unit of blood. The lymphocytes are then separated and removed by a cell separator machine, and the rest of the blood is returned through a needle in the other arm. Before treatment begins, patients have a central venous catheter (flexible plastic tube) placed in a vein. This line remains in place during the stem cell transfusion and recovery period for drawing and transfusing blood, giving medications, and infusing the donated cells. Preparation for the transfusion includes irradiation and chemotherapy. Patients undergo total body irradiation in 8 doses given in two 30-minute sessions a day for 4 days. Four days before the transfusion, they begin taking cyclophosphamide, and 9days before the procedure they start fludarabine. These are anti-cancer drugs that kill the cancer cells and prevent rejection of the donated cells. While the patient is receiving chemotherapy, the donor receives daily injections for 6 days of G-CSF, a drug that moves stem cells from the bone marrow into the blood stream. On days 1 and 2 after chemotherapy is completed, the stem cells are infused into the patient through the central line. Patients usually stay in the hospital about 20 to 30 days after the transplant to recover from treatment side effects, which may include fever, nausea, diarrhea and mouth pain, and receive blood transfusions, if needed. Treatment with cyclosporine, a drug that helps prevents both rejection of donated cells and GVHD, is started on day 44 one day before the first T-cell add-back. Patients return to the clinic for follow-up with various tests, treatments and examinations as required, with a minimum of visits at least once or twice a week for 2 to 4 months after the transplant; then at 4, 6, 9, and 12 months, and then yearly for at least 3 years.

NCT ID: NCT00352677 Completed - Clinical trials for Chronic Myeloid Leukemia

Safety and Tolerability Study of INNO-406 to Treat Chronic Myeloid Leukemia or Acute Lymphocytic Leukemia

Start date: July 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and effectiveness of INNO-406 in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.

NCT ID: NCT00352365 Completed - Clinical trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

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

This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

NCT ID: NCT00352001 Completed - Leukemia Clinical Trials

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes

Start date: May 2006
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving lenalidomide together with azacitidine may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide and azacitidine in treating patients with advanced myelodysplastic syndromes.

NCT ID: NCT00351975 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases

Start date: June 2006
Phase: Phase 1
Study type: Interventional

This phase I trial is studying the side effects and best dose of belinostat when given together with azacitidine in treating patients with advanced hematologic cancers or other diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving belinostat together with azacitidine may kill more cancer cells.

NCT ID: NCT00350818 Completed - Leukemia Clinical Trials

Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation (Allo BMT)

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

Primary Objective: -To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance treatment after allogeneic transplantation for high-risk AML / MDS. Secondary Objective: -To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML / MDS.

NCT ID: NCT00350181 Completed - Leukemia Clinical Trials

Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT

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

GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL

NCT ID: NCT00349596 Completed - Clinical trials for Acute Lymphocytic Leukemia

A Study of Low-Dose Decitabine in Relapsed or Refractory Acute Lymphocytic Leukemia (ALL)

Start date: July 2006
Phase: Phase 1
Study type: Interventional

The goal of this clinical research study is to find the safety of decitabine in patients with acute lymphocytic leukemia. Upon agreement of the patient, additional blood and bone marrow samples to be used to evaluate the effect of the treatment on leukemic cells. Also, with agreement of the patient, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia.

NCT ID: NCT00349349 Completed - Clinical trials for Leukaemia, Lymphocytic, Chronic

HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

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

The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.

NCT ID: NCT00348985 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

PXD101 and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas

Start date: March 2006
Phase: Phase 1
Study type: Interventional

This phase I trial is studying the side effects and best dose of PXD101 and bortezomib in treating patients with advanced solid tumors or lymphomas. PXD101 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PXD101 may also cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving PXD101 together with bortezomib may kill more cancer cells.