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Leukemia clinical trials

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NCT ID: NCT00591526 Completed - Clinical trials for Leukemia, Promyelocytic, Acute

A Randomized Trial Assessing the Roles of AraC in Newly Diagnosed APL Promyelocytic Leukemia (APL)

Start date: June 2000
Phase: Phase 3
Study type: Interventional

The first purpose of this randomized trial will be to compare the best treatment group of APL 93 trial (ATRA with early introduction of anthracycline-AraC chemotherapy, followed by 2 consolidation anthracycline-AraC courses and maintenance combining continuous chemotherapy and intermittent ATRA) to the same regimen, but without AraC. It is hoped that the investigational arm, with anthracycline alone chemotherapy (without AraC), will have reduced toxicity without increasing the incidence of relapse, by comparison with a classical induction/consolidation anthracycline-AraC regimen Thus : the main end point for this first randomization is relapse at 2 years secondary end points are : complete remission rate ; survival and event free survival at 2 years, and quality-adjusted survival (Q-TWiST). 2) Because patients with initial WBC counts > 10000/mm3 (ie very high counts for APL) appear to remain at relatively high risk of relapse even with the current reference treatment, they will not be included in this trial that assesses the reduction of chemotherapy. On the contrary: i) they will all receive the standard chemotherapy (best treatment group of APL 93 trial); Thus : the main end point for this second randomization is relapse at 2 years secondary end points are : survival and event free survival at 2 years 3)Elderly patients with initial WBC ≤ 10000/m3 will receive consolidation chemotherapy without AraC during the first chemotherapy course, and reduced doses of AraC during the second and third course, followed by G-CSF.

NCT ID: NCT00590837 Completed - Clinical trials for Acute Myeloid Leukemia

Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old

LAM-SA 2007
Start date: February 2008
Phase: Phase 3
Study type: Interventional

A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

NCT ID: NCT00590187 Completed - Clinical trials for Acute Myeloid Leukemia

Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

Start date: December 2007
Phase: Phase 2
Study type: Interventional

The objective is to treat elderly AML and MDS patients with sapacitabine.

NCT ID: NCT00589563 Completed - Lymphoma Clinical Trials

Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer

Start date: May 2007
Phase: Phase 2
Study type: Interventional

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops 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). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, antithymocyte globulin, and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte globulin work in preventing graft-versus-host disease in patients undergoing a donor stem cell transplant for hematological cancer .

NCT ID: NCT00588809 Completed - Clinical trials for Myelodysplastic Syndromes

Selumetinib in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia

Start date: December 2007
Phase: Phase 2
Study type: Interventional

This phase II clinical trial is studying how well selumetinib works in treating patients with recurrent or refractory acute myeloid leukemia. Selumetinib may stop the growth of cancer by blocking some of the enzymes needed for cell growth

NCT ID: NCT00587054 Completed - Leukemia Clinical Trials

Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders

Start date: June 2001
Phase: Phase 2
Study type: Interventional

This is a phase II, single-center study to evaluate the efficacy of a novel cytoreductive regimen followed by CD34+E- selected T cell depleted allogeneic stem cell (or soybean agglutinated and E-rosetted BM) transplant as treatment for patients with acute and chronic leukemias, lymphoma and myelodysplstic syndrome/PNH. The impact of the change in conditioning regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and mortality and disease free survival will be assessed.

NCT ID: NCT00586924 Completed - Hairy Cell Leukemia Clinical Trials

A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia

Start date: May 10, 2007
Phase: Phase 1
Study type: Interventional

A dose-escalation study to identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), defined as the highest dose that can safely be given to a participant and establish the safest dose based on the highest tolerated dose for clinical testing.

NCT ID: NCT00586547 Completed - Cancer Clinical Trials

Evaluating the Use of RFT5-dgA to Deplete Alloreactive Cells Prior to Haploidentical Stem Cell Transplantation

Start date: July 2000
Phase: Phase 1
Study type: Interventional

This study is designed to determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result in a rate of Grade III/IV GVHD of < / = 25%, to analyze immune reconstitution in these patients, and to measure their overall and disease free survival, at 100 days and at 1 year.

NCT ID: NCT00582933 Completed - Leukemia Clinical Trials

Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related or Unrelated Donor

Start date: May 2001
Phase: Phase 2
Study type: Interventional

The purpose of this research study is:(1) to determine if high doses of chemotherapy without total body irradiation can allow selected stem cells to take and grow,(2) to determine if selected stem cells from the blood or marrow can take and not cause a complication called graft-versus-host disease (GvHD) and (3) to evaluate the side effects of the combination of chemotherapy drugs used for these transplants. In the last 10 years we have developed chemotherapy combinations to be used for this T-cell depleted transplant protocol. By using three chemotherapy drugs (IV busulfan, melphalan and fludarabine), we hope to have a good chemotherapy combination to kill cancer cells, and to make the graft take, without the side effects of total body irradiation. The chemotherapy drugs to be tested in this protocol are busulfan, melphalan and fludarabine, all of which have been used successfully for stem cell transplantation, but not given together as in this specific regimen. This is what is being tested in this study. Our initial trials in the 1980's with T-cell depleted transplants showed less GvHD, but the overall results of the transplants were not better. The reason for this was that the stem cells did not take and engraft in 15% of our adult patients. This failure of the stem cells to take can leave patients without bone marrow or blood cells necessary for life. Most stem cell transplants were done using bone marrow (BMA) obtained from the donors. However, if we give a medication called G-CSF by shots to the donor, we can collect peripheral blood stem cells (PBSC) and use them for transplant. The advantage of this approach is that we can collect 2-20 times more stem cells than that obtained from the marrow. It has been proven that a larger number of stem cells in the graft make it more difficult for the patient to reject the stem cells. Some donors may be too small to provide peripheral blood stem cells or they may not want to take G-CSF shots. In these cases the donors will have their marrow collected in the operating room under general anesthesia. Stem cell transplants can lead to a condition known as acute graft-versus-host disease or GvHD. This disease is caused by an assault by certain cells in the marrow or blood (T-cells) of the donor (graft) against your body (the host). These T-cells see your body as foreign and attack it. The disease causes a skin rash, liver disease, and diarrhea. Methods were developed at this institution to prevent GvHD. These methods take out most of the T-cells (responsible for GvHD) from the marrow or blood stem cells before transplant. This is called "T-cell depletion" or "stem cell selection". In this hospital, we use two types of methods of T-cell depletion: one method is used with peripheral blood stem cells and one for bone marrow. Both these techniques have been successful in preventing both acute and chronic GvHD. You will receive a T-cell depleted stem cell transplant.

NCT ID: NCT00581646 Completed - Leukemia Clinical Trials

Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance

Start date: September 2006
Phase: N/A
Study type: Observational

This study aims to learn about the needs and feelings of women who are infertile. Being infertile means not being able to have a child without the help of a third party. There are other options for building a family. The researchers are interested in the participants' thoughts about these options and want to learn about the experiences of infertile women due to cancer treatment as well as women who are infertile due to other causes. The researchers hope that what they learn will allow them to better care for infertile women in the future.