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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT00539695 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Low Dose IL-2, Hematopoietic Stem Cell Transplantation, IL2 for GVHD

IL2 for GVHD
Start date: June 2007
Phase: Phase 2
Study type: Interventional

Patients are being asked to participate in this study because treatment for their disease requires a stem cell transplant (SCT). Stem cells are the source of normal blood cells found in the bone marrow and lead to recovery of blood counts after bone marrow transplantation. With stem cell transplants, regardless of whether the donor is a full match to the patient or not, there is a risk of developing graft-versus-host disease (GVHD). GVHD is a serious and sometimes fatal side effect of SCT. GVHD occurs when the new donor stem cells (graft) recognizes that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs. How much this happens and how severe the GVHD is depends on many things, including how different the donors cells are, the strength of the drugs given in preparation for the transplant, the quality of transplanted cells and the age of the person receiving the transplant. Typically, acute GVHD occurs in the first 100 days following transplant, while chronic GVHD occurs after day 100. Acute GVHD most often involves the skin, where it can cause anywhere from a mild rash to complete removal of skin; liver, where it can anywhere from a rise in liver function tests to liver failure; and the gut, where it can cause anywhere from mild diarrhea to profuse, life-threatening diarrhea. Most patients who develop GVHD experience a mild to moderate form, but some patients develop the severe, life-threatening form. Previous studies have shown that patients who receive SCT's can have a lower number of special T cells in their blood, called regulatory T cells, than people who have not received stem cell transplants. When regulatory T cells are low, there appears to be an increased rate of severe, acute GVHD. A drug known as IL-2 (Proleukin) has been shown to increase the number of regulatory T cells in patients following stem cell transplant, and in this study investigators plan to give low dose IL-2 after transplant. This study is called a phase II study because its major purpose is to find out whether using a low-dose of IL-2 will be effective in preventing acute GVHD. Other important purposes are to find out if this treatment helps the patient's immune system recover regulatory T cells faster after the transplant. This study will assess the safety and toxicity of low-dose IL-2 given to patients after transplantation and determine whether this drug is helpful in preventing GVHD.

NCT ID: NCT00538876 Completed - Clinical trials for Acute Myeloid Leukemia

Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML

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

This is an open label phase I study designed to explore the feasibility, safety and biologic activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin induction chemotherapy in younger patients with less-than-favorable risk AML. Primary Objective: To find an appropriate dose level for decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML. Secondary Objectives: 1. To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML. 2. To establish the optimal dose schedule of decitabine required to broadly demethylate cytosine residues in genomic regulatory regions. 3. To investigate, in selected cases, the molecular and cellular consequences of decitabine-induced hypomethylation by a) establishing the extent and degree of hypomethylation at specific genomic loci required to reactivate the expression of repressed genes and by b) determining the effect of hypomethylation on the differentiation and/or apoptosis of leukemic blasts.

NCT ID: NCT00536601 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors

Start date: June 29, 2006
Phase: N/A
Study type: Interventional

This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for the stem cell transplant. The stem cells are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy.

NCT ID: NCT00531232 Completed - Clinical trials for Myelodysplastic Syndromes

A Dose Confirmation Study of Oral Clofarabine for Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)

Start date: May 7, 2007
Phase: Phase 2
Study type: Interventional

There was no well accepted standard of care for participants who failed or were intolerant to any of the currently approved therapies for myelodysplastic syndromes (MDS). In this study, participants were initially assigned to receive 55 or 35 milligrams (mg) of oral clofarabine daily for 5 days. After safety review of the first participants enrolled, the dose was reduced to 25 milligrams per day (mg/day) for up to 8 cycles as long as the participants continued to benefit and in the absence of progressive disease.

NCT ID: NCT00530699 Completed - Clinical trials for Acute Myeloid Leukaemia

Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)

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

The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia who are not considered to be suitable for standard chemotherapy.

NCT ID: NCT00529360 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Allogeneic Stem Cell Transplant With Clofarabine, Ara-C and TBI for AML and ALL

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

Hypothesis: Myeloablative conditioning using a dose escalation of clofarabine in combination with cytarabine (ARA-C) and total body irradiation (TBI) will lead to improved survival for previously untransplanted children and adolescents with acute lymphoblastic leukemia (ALL) and acute non-lymphoblastic leukemia (ANLL)followed by allogeneic stem cell transplantation (AlloSCT).

NCT ID: NCT00528983 Completed - Clinical trials for Myelodysplastic Syndromes (MDS)

Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous Leukemia

Start date: September 11, 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether a tablet form of azacitidine that taken by mouth is safe. This Phase I study will also look at different doses and different treatment schedules in order to better understand the effects (positive and negative) of oral azacitidine on the body and on the disease MDS, AML and CMML.

NCT ID: NCT00528398 Completed - Leukemia Clinical Trials

Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

Start date: September 1994
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

NCT ID: NCT00528333 Completed - Clinical trials for Acute Myeloid Leukemia

A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML

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

The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.

NCT ID: NCT00516152 Completed - Multiple Myeloma Clinical Trials

Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

Start date: November 2002
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.