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Leukemia, Myeloid clinical trials

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NCT ID: NCT01366612 Terminated - Clinical trials for Myelodysplastic Syndrome

PRO#1278: Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation

FLUBUTBI
Start date: June 16, 2010
Phase: Phase 3
Study type: Interventional

This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan and low dose total body irradiation in patients undergoing allogeneic stem cell transplantation. A study population of 80 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will be randomly assigned to receive one of 2 conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total body irradiation (TBI). Subjects will be followed until 1 year post transplantation to assess the relapse rate in each arm and transplant-related toxicity. The combination of fludarabine and busulfan is the current standard of care for patients with myeloid malignancies (AML, CML and other myeloproliferative disorders, or MDS) undergoing allogeneic transplantation at HUMC. In this study we will be comparing in a randomized fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.

NCT ID: NCT01342887 Terminated - Clinical trials for Recurrent Adult Acute Myeloid Leukemia

Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of etoposide and mitoxantrone hydrochloride when given together with cyclosporine and pravastatin sodium and to see how well they work in treating patients with relapsed or refractory acute myeloid leukemia (AML). Cyclosporine may inhibit efflux of cancer drugs out of cancer cells and may thereby improve chemotherapy treatment for AML. Pravastatin sodium may stop the growth of cancer cells by blocking some of the nutrients needed for cell growth. Drugs used in chemotherapy, such as etoposide and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving cyclosporine together with pravastatin sodium, etoposide, and mitoxantrone hydrochloride may kill more cancer cells

NCT ID: NCT01339910 Terminated - Clinical trials for Leukemia, Myelocytic, Acute

Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The study is designed as a Phase III, multicenter trial comparing outcomes after allogeneic hematopoietic stem cell transplantation (HCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) between patients receiving myeloablative conditioning (MAC) versus reduced intensity conditioning (RIC) regimens.

NCT ID: NCT01326728 Terminated - Clinical trials for Acute Lymphoblastic Leukemia

Relapsed Malignant Blood Cancer After Allogeneic Hematopoietic Stem Cell Transplantation

Start date: March 30, 2011
Phase:
Study type: Observational

Background: Allogeneic hematopoietic stem cell transplantation (or allotransplant; donor blood stem cells) have been used with varying degrees of success as an immune therapy for blood-system cancers (leukemias, myelodysplastic syndrome, lymphomas, multiple myeloma, etc.). Some people s cancer remains active (comes back or continues to spread) after an allotransplant, while other peoples cancer disappears and they are hopefully cured. National Institutes of Health (NIH) researchers are studying the reasons for these different treatment outcomes, and trying to develop better cancer treatments for people with active cancer after allotransplant. Researchers are collecting data from people who have had allotransplants for a cancer of the blood, whether or not the cancer is in remission, and from their donors. Those with active cancers may be eligible to participate in one of several NIH studies testing treatments for active cancer after allotransplant. Objectives: - To develop a systematic, comprehensive evaluation of individuals with relapsed malignant blood cancers after allotransplant (and, if available, their donors) to identify potential treatment study options - To compare the immune system after allotransplant between people whose cancers are growing with people whose cancers remain in remission. - To compare the immune system after cancer relapse/progression treatment between people whose cancer responds to treatment with those whose cancers continue to grow. Eligibility: - Individuals whose blood system cancer grows or comes back after receiving allotransplant treatment. - Individuals whose blood system cancer is responding or in remission 100 days or more after receiving allotransplant treatment. - Related stem-cell donors of eligible allotransplant recipients. Design: - Participants will be evaluated with a full physical examination, detailed medical history (for recipients, including a history of allotransplant treatment process, side-effects, etc.), and blood tests. Recipients will also have imaging studies, possible tissue biopsies, quality of life questionnaires/assessments, and other tests to evaluate the current state of their cancer, whether active or in remission. In some cases, it may be possible to substitute results from recent tests and/or biopsies. - Healthy related donors will have apheresis to provide white blood cells for study and/or for use in potential treatment options. If stem cells would be medically helpful to a recipient, their donors might be asked to take injections of filgrastim before the apheresis procedure to stimulate the production of stem cells for collection. - As feasible, all recipients will be asked to return to the NIH for detailed follow-up visits in conjunction with 6, 12, and 24 months post-allotransplant evaluations, and may be monitored between visits. - Recipients whose cancers are active and who are found to be eligible for treatment protocols at the NIH will continue to be monitored on this study while participating on treatment protocols. Return visits and follow-up tests for this study will be coordinated with those required by the treatment protocol. - Participants may return in the future to be evaluated for new treatment study options (recipients) or additional cell donations for therapy (donors).

NCT ID: NCT01300611 Terminated - Clinical trials for Chronic Lymphocytic Leukemia

TXA127 in Enhancement of Engraftment in Adult Double Cord Blood Transplantation

USBTXA127CBT
Start date: January 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of TXA127 on neutrophil and platelet counts in adult patients who have undergone a double cord blood transplant. The study will also evaluate the effect of TXA127 on chemotherapy-induced mucositis, an inflammation of the mucous membranes in the digestive tract (mouth to anus) and immune reconstitution which helps patients fight infections. For patients undergoing CBT, both neutrophil and platelet normalization and immune reconstitution can be delayed. TXA127 has shown to be well tolerated by patients and appears to induce a rapid production of neutrophils and platelets in the bloodstream as well as increase the immune system components. It has also been shown to reduce the severity of chemotherapy-induced mucositis.

NCT ID: NCT01289678 Terminated - Clinical trials for Acute Myelogenous Leukemia

Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia

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

Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.

NCT ID: NCT01265199 Terminated - Clinical trials for Acute Myelogenous Leukemia (AML)

Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk Acute Myelogenous Leukemia (AML)

Start date: February 2011
Phase: Phase 1
Study type: Interventional

The main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help determine how AT-406 works. Side effects will also be studied in an effort to make sure that this drug is safe to take.

NCT ID: NCT01260714 Terminated - Clinical trials for Recurrent Adult Acute Myeloid Leukemia

Azacitidine, Mitoxantrone Hydrochloride, and Etoposide in Treating Older Patients With Poor-Prognosis Acute Myeloid Leukemia

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

This phase I trial studies the best dose of azacitidine and to see how well it works with mitoxantrone hydrochloride and etoposide in treating older patients with acute myeloid leukemia that has a lower chance of responding to treatment or higher risk of returning (poor prognosis). Drugs used in chemotherapy, such as azacitidine, mitoxantrone hydrochloride, and etoposide, 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.

NCT ID: NCT01246752 Terminated - Clinical trials for Leukemia, Myeloid, Acute

Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR

AML
Start date: February 10, 2011
Phase: Phase 3
Study type: Interventional

Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy

NCT ID: NCT01222143 Terminated - Clinical trials for Acute Myeloid Leukemia

Safety and Efficacy Study of Nilotinib Combined With Mitoxantrone, Etoposide, and High-dose Cytarabine Induction Chemotherapy Followed by Consolidation for Patients With C-kit Positive Acute Myeloid Leukemia

Start date: October 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II open-label study that is evaluating the toxicity and efficacy of nilotinib combined with mitoxantrone, etoposide, and high-dose cytarabine (NOVE-HiDAC) chemotherapy for patients with poor-risk acute myeloid leukemia (AML). There are two parts to the study. The first part (Phase I) will determine the maximum dose of nilotinib that can safely be given when combined with NOVE-HiDAC. This dose will then be used in combination with the NOVE-HiDAC regimen in the second part of the study (Phase II), which will evaluate the antileukemic activity of the treatment. The patients who achieve complete remission from the induction therapy (1 cycle) will then receive consolidation therapy combined with nilotinib (maximum of 2 cycles). The patient population for this study will have AML and will fall into a poor risk category. This means they have persistent leukemia after induction therapy, they relapse within two years of achieving complete remission with induction therapy, or they have certain poor risk features at diagnosis. The AML cells will also be positive for c-kit (a stem cell factor receptor), which is involved in cancer cell growth. Nilotinib is a drug that blocks the effects of c-kit. Using this drug in combination with chemotherapy may improve ability of the chemotherapy drugs to kill leukemia cells. This may then increase the chances of the leukemia going into complete remission.