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Leukemia, Myeloid clinical trials

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NCT ID: NCT01180426 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

Start date: June 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.

NCT ID: NCT01180322 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Trial Evaluating Induction Therapy With Idarubicin and Etoposide Plus Sequential or Concurrent Azacitidine and Maintenance Therapy With Azacitidine

azacitidine
Start date: November 2010
Phase: Phase 2
Study type: Interventional

This is a randomized phase II, four-arm, open-label, multi-center study in adult patients with acute myeloid leukemia (AML) as defined in inclusion/exclusion criteria. The primary efficacy objective is to evaluate the impact of sequential or concurrent addition of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on the complete remission (CR) rate Sample size: 336 patients The treatment duration of an individual patient randomized into one of the three experimental arms (Arm B, C, D) (in case of application of induction, consolidation and maintenance therapy with Azacitidine) is about 30 months. The treatment duration for patients randomized into the standard arm of the study (Arm A) is about 7 months (in case of application of induction, consolidation and 2-yrs observation as maintenance (without treatment with Azacitidine)). In case of induction followed by consolidation with allogeneic Stem cell transplantation (SCT) the treatment duration per patient is about 6 months. Every patient will be followed until month 54 after inclusion into the study. Duration of the study for an individual patient including treatment (induction, consolidation [chemotherapy or allogeneic SCT], maintenance [experimental arm with Azacitidine or observation]) and follow-up period: 54 months

NCT ID: NCT01177540 Terminated - Clinical trials for Pediatric Acute Myelogenous Leukemia (AML)

Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects

Start date: March 3, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is currently unavailable.

NCT ID: NCT01177371 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma

Start date: March 1988
Phase: Phase 2
Study type: Interventional

RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor bone marrow transplant helps stop the growth of cancer cells. It may also 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 cyclosporine, methylprednisolone, and methotrexate after transplant may stop this from happening. PURPOSE: This clinical trial studies high-dose busulfan and high-dose cyclophosphamide followed by donor bone marrow transplant in treating patients with leukemia, myelodysplastic syndrome, multiple myeloma, or recurrent Hodgkin or Non-Hodgkin lymphoma.

NCT ID: NCT01175785 Completed - Clinical trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Infusion of Off-the-Shelf Expanded Cord Blood Cells to Augment Cord Blood Transplant in Patients With Hematologic Malignancies

Start date: August 2010
Phase: Phase 2
Study type: Interventional

This phase II trial is studying the safety and potential efficacy of infusing non-human leukocyte antigen matched ex vivo expanded cord blood progenitors with one or two unmanipulated umbilical cord blood units for transplantation following conditioning with fludarabine phosphate, cyclophosphamide and total body irradiation, and immunosuppression with cyclosporine and mycophenolate mofetil for patients with hematologic malignancies. Chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation given before an umbilical cord blood transplant stops the growth of leukemia cells and works to prevent the patient's immune system from rejecting the donor's stem cells. The healthy stem cells from the donor's umbilical cord blood help the patient's bone marrow make new red blood cells, white blood cells, and platelets. It may take several weeks for these new blood cells to grow. During that period of time, patients are at increased risk for bleeding and infection. Faster recovery of white blood cells may decrease the number and severity of infections. Studies have shown that counts recover more quickly when more cord blood cells are given with the transplant. We have developed a way of growing or "expanding" the number of cord blood cells in the lab so that there are more cells available for transplant. We are doing this study to find out whether or not giving these expanded cells along with one or two unexpanded cord blood units is safe and if use of expanded cells can decrease the time it takes for white blood cells to recover after transplant. We will study the time it takes for blood counts to recover, which of the two or three cord blood units makes up the patient's new blood system, and how quickly immune system cells return.

NCT ID: NCT01174888 Completed - Clinical trials for Acute Myeloid Leukemia

Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia

Start date: August 2010
Phase: Phase 1
Study type: Interventional

RATIONALE: Bortezomib and midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, 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 bortezomib and midostaurin together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with midostaurin with or without combination chemotherapy in treating patients with relapsed or refractory acute myeloid leukemia.

NCT ID: NCT01170598 Completed - Clinical trials for Acute Myeloid Leukemia

Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy

Start date: June 2010
Phase: Phase 2
Study type: Interventional

Fatigue, reduced quality of life and declines in physical function are common in patients undergoing chemotherapy for acute myeloid leukaemia (AML). Studies in other cancer patients undergoing treatment have shown that exercise improves these symptoms, but there are limited studies in AML. This study of a hospital-based exercise program will help determine if exercise is both feasible and helpful in improving symptoms among for AML patients undergoing chemotherapy.

NCT ID: NCT01169753 Terminated - Clinical trials for Chronic Myeloid Leukemia

Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients

Start date: May 2011
Phase: N/A
Study type: Interventional

The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with CML. The safety of this drug will also be studied.

NCT ID: NCT01169363 Completed - Leukemia Clinical Trials

Biomarkers in Bone Marrow and Blood Samples From Older Patients With Acute Myeloid Leukemia Treated With Cytarabine-Based Therapy

Start date: July 8, 2010
Phase: N/A
Study type: Observational

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with cytarabine-based therapy.

NCT ID: NCT01169012 Completed - Clinical trials for Acute Myeloid Leukemia

PK Study of Oral and IV Clofarabine in High Risk Myelodysplasia+Acute Leukemias

Start date: September 2010
Phase: Phase 1
Study type: Interventional

This is a non-blinded, non-randomized pharmacokinetic study to determine the oral bioavailability of clofarabine, and the effect of cimetidine on clofarabine pharmacokinetics in patients with poor-risk acute leukemias and myelodysplastic syndrome (MDS).