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Leukemia clinical trials

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NCT ID: NCT01287104 Completed - Lymphoma Clinical Trials

A Phase I Study of NK Cell Infusion Following Allogeneic Peripheral Blood Stem Cell Transplantation From Related or Matched Unrelated Donors in Pediatric Patients With Solid Tumors and Leukemias

Start date: January 29, 2011
Phase: Phase 1
Study type: Interventional

Background: - Bone marrow stem cells, which are found in the bone marrow and blood stream, can be collected and transplanted to treat a variety of types of cancer in a process known as hematopoietic stem cell transplantation (HSCT). When stem cells are taken from one person, most commonly a sibling or a family member, and then given to another person, this is referred to as allogeneic HSCT. Allogeneic HSCT has proven to be an especially effective treatment for patients with some types of cancers of the blood (leukemia) and certain solid tumors. The transplanted stem cells travel to the patient's bone marrow and begin producing normal blood cells, and also attack patients cancer cells. - Because allogenic HSCT does not always prevent the cancer from returning, researchers are interested in determining whether another type of immune cell taken from the stem cell donors white blood cells, called a "natural killer" (NK) cell, can be given in addition to the HSCT to help fight the tumor. In the laboratory, NK cells have been shown to kill tumor cells, but it is not yet know if this will occur when given to patients after HSCT. Objectives: - To determine the safety, effectiveness, and immune system response of giving NK white blood cells to individuals who have received allogeneic HSCT. - To identify possible side effects from the treatment. Eligibility: - Donors: Stem cell donors whose blood matches one of the recipients on six out of six human leukocyte antigen (HLA) (blood immune marker) types. The donor may not be the identical twin of a recipient. - Recipients: Individuals between 4 and 35 years of age who have been diagnosed with pediatric solid tumors that have not responded to standard treatment, or individuals between 4 and 18 years of age who have been diagnosed with leukemia that has not responded to standard treatment. - Other eligibility requirements which include a physical exam and blood laboratory evaluation are included to make sure it is safe for both the donor to donate and the recipient to undergo the transplant procedure. Design: - Donors and recipients will be screened with a full medical history and physical examination, and will provide blood and urine samples; recipients will have tumor imaging studies and other tests as required by the researchers. - Donors: - Participants will receive filgrastim injections (to stimulate the bone marrow) for 1 week to make stem cells travel from bone marrow to blood. - Participants will provide stem cells and NK cells through apheresis. - Recipients: - Participants will have three cycles of chemotherapy to treat the underlying cancer and weaken the immune system so that it will accept the donor cells. - Participants will then receive preparative chemotherapy for the transplant and two days after the last dose of chemotherapy, participants will have allogenic HSCT using the donated stem cells. - Participants will receive an infusion of NK cells on days 7 and 35 after the HSCT. - Participants will remain in the hospital for monitoring after the HSCT and NK cell treatments, and will be followed closely as outpatients for the first 6 months after the transplant and then less frequently for at least 5 years.

NCT ID: NCT01284010 Completed - Leukemia Clinical Trials

Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia

Start date: February 2011
Phase:
Study type: Observational

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia.

NCT ID: NCT01283386 Terminated - Clinical trials for Lymphocytic Leukemia, Chronic

A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Start date: April 27, 2011
Phase: Phase 4
Study type: Interventional

This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously [IV] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.

NCT ID: NCT01281735 Recruiting - Clinical trials for Chronic Myeloid Leukemia

International Chronic Myeloid Leukemia Pediatric Study

ICMLPed
Start date: January 2011
Phase:
Study type: Observational

The purpose of the study is to describe and characterize CML in a large pediatric cohort of patients.

NCT ID: NCT01280786 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia

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

This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.

NCT ID: NCT01279707 Unknown status - Clinical trials for Recurrent or Refractory B Cell Acute Lymphoblastic Leukaemia

Monoclonal Antibodies in Recurrent or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL) (MARALL)

MARALL
Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The treatment of adult B-cell acute lymphoblastic leukaemia (ALL) has progressed considerably in the past 3 decades, particularly due to intensification of chemotherapies, improved supportive care and the incorporation of stem cell transplantation. However, the maximum tolerability of standard chemotherapeutics has been reached in ALL. Using conventional chemotherapy, 80-85% of adults with ALL will achieve a complete remission (CR). Unfortunately treatment at relapse is generally unsuccessful and rarely results, in long-term survival (7% survival at 5 years). Therefore, the investigators are exploring novel treatment strategies through the use of monoclonal antibodies (MoAbs) directed at surface antigens on leukaemic blasts. Using MoAbs directed against surface proteins on B cells has had excellent results in other B-cell diseases such as low and high grade non-Hodgkin lymphomas, without additional toxicity. There has also been limited evidence from small studies and case reports of the efficacy of MoAbs in ALL. This is a Phase I/II study to determine the safety and tolerability of the combination of veltuzumab and epratuzumab with intensive chemotherapy in patients with relapsed B-cell ALL. A maximum of 51 patients will be treated with a combination of UKALL XII induction chemotherapy and the monoclonal antibodies veltuzumab and epratuzumab. Veltuzumab and epratuzumab are humanised monoclonal antibodies that target CD20 and CD22 surface proteins, respectively. Both of these proteins are expressed on ALL tumour B cells. One group of patients will receive modified UKALL XII chemotherapy + veltuzumab; a second, modified UKALL XII chemotherapy + epratuzumab and if limited toxicity is found in these first 2 groups, a third group will receive, modified UKALL XII chemotherapy + both veltuzumab and epratuzumab. Patients will be assessed for safety, tolerability and disease response. Safety and tolerability will be measured by the number of Dose Limiting Toxicities (DLTs) in each group. Disease response will be measured by the microscopic appearance of patient bone marrow samples at day 29, and by molecular tests for tumour cells in bone marrow.

NCT ID: NCT01279473 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)

Start date: August 2005
Phase: Phase 1/Phase 2
Study type: Interventional

This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.

NCT ID: NCT01279252 Completed - Clinical trials for Chronic Lymphocytic Leukaemia (CLL)

CLL Empirical Antibiotic Regimen

CLEAR
Start date: July 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether patients with previously untreated, early stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis that occult bacterial infections are involved in the induction and maintenance of CLL.

NCT ID: NCT01279096 Completed - Clinical trials for Acute Lymphoid Leukemia Relapse

Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia

Vandevol
Start date: January 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).

NCT ID: NCT01274533 Completed - Clinical trials for Adult T Cell Leukemia/Lymphoma

Lenalidomide in HTLV-1 Adult T-Cell Leukemia

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

This is a research study for subjects who have been diagnosed with Adult T cell Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of this research study is to evaluate the use of the investigational drug lenalidomide in the treatment of Adult T cell Leukemia/Lymphoma. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.