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Leukemia, Lymphoid clinical trials

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NCT ID: NCT01047020 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Motor Proficiency And Physical Activity in Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

Start date: June 2009
Phase: N/A
Study type: Observational

The primary goal of this study is to provide comprehensive and objective information on impairments of musculoskeletal health, sensory function, and fitness among a large group of childhood ALL survivors, and to define high risk groups by assessing treatment factors that contribute to impaired function. This study includes a direct, objective evaluation of musculoskeletal function, sensory capacity, fitness, and physical activity patterns among adults who were treated for childhood ALL at St. Jude Children's Research Hospital (SJCRH) between 1980 and 1999. Among 899 ALL survivors, all of whom are eligible for an institutionally funded clinical study of medical late effects, the study will recruit 364 to participate in our evaluations. The study will also recruit 364 individuals for a comparison group, frequency matching on race/ethnicity, age and gender.

NCT ID: NCT01045382 Terminated - Multiple Myeloma Clinical Trials

MSC and HSC Coinfusion in Mismatched Minitransplants

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

The present project aims at evaluating the capacity of MSC to improve one-year overall survival of patients transplanted with HLA-mismatched PBSC from related or unrelated donors after non-myeloablative conditioning. Co-infusion of MSC has been shown to facilitate engraftment of hematopoietic stem cell (HSC) in an immunodeficient mouse model. In addition, it has been shown that infusion of third party MSC in HSC transplantation could be successfully used as treatment for grade II-IV steroid-refractory acute graft versus host disease. One hundred and twenty patients with HLA-mismatched donors will be included over 6 years at multiple centers across Belgium through the transplant committee of the Belgian Hematological Society. The conditioning regimen will consist of fludarabine and 2 Gy TBI, followed by the infusion of donor HSC. Patients will be randomized 1/1 in double-blind fashion to receive or not MSC (1.5-.3.0 x106/kg) from third-party (either haploidentical family members or unrelated volunteer) donors on day 0. Postgrafting immunosuppression will combine tacrolimus and MMF. Except for the collection, expansion and infusion of MSC, the clinical management of the patient will not differ from that of routine NM-HCT.

NCT ID: NCT01044745 Terminated - Clinical trials for Graft Versus Host Disease

Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer

Start date: December 10, 2009
Phase: Phase 2
Study type: Interventional

This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop 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 a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening

NCT ID: NCT01044069 Active, not recruiting - Leukemia Clinical Trials

Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

Start date: January 5, 2010
Phase: Phase 1
Study type: Interventional

This study is an investigational approach that uses immune cells, called "T cells", to kill leukemia. These T cells are removed from blood, modified in a laboratory, and then put back in the body. T cells fight infections and can also kill cancer cells in some cases. However, right now T cells are unable to kill the cancer cells. For this reason we will put one gene into the T cells that allows them to recognize and kill the leukemia cells. This gene will be put in the T cells by a weakened virus. The gene will produce proteins in the T cells that help the T cells recognize the leukemia cells and possibly kill them. The doctors have found that T cells modified in this way can cure an ALL-like cancer in mice. The main goals of this study is to determine the safety and appropriate dose of these modified T cells in patients with ALL. This will be done in a "clinical trial." The dose of modified T-cells will depend on if you have disease present in your bone marrow or not. The patient will also receive chemotherapy before the T cells. We will use normally chemotherapy that is used in patients with leukemia. The chemotherapy is given to reduce leukemia and to allow the T cells to live longer.

NCT ID: NCT01041508 Completed - Clinical trials for Acute Myeloid Leukemia

Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.

Start date: January 29, 2010
Phase: Phase 1
Study type: Interventional

Stem cell transplant is an important therapeutic option for pediatric patients with relapsed or refractory leukemia. Although, full myeloablative transplants are widely used for patients with acute leukemia, myeloablative chemo-radiotherapy may not be feasible in some specific settings. These settings include 1) patients with pre-existing health issues and organ toxicities; 2) patients who have relapsed post-ablative transplant and need a second stem cell transplant; and 3) leukemia patients with advanced disease who have been heavily pre-treated. Clofarabine, a new purine nucleoside anti-metabolite, has the advantage of significant antileukemic activity in addition to its possible immuno-suppressive properties. In this study we plan to determine the maximum feasible dose (MFD) of Clofarabine in combination with total body irradiation that can achieve durable donor engraftment without causing excessive toxicity.

NCT ID: NCT01039376 Terminated - Clinical trials for Leukaemia, Lymphocytic, Chronic

Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy

PROLONG
Start date: May 6, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.

NCT ID: NCT01037764 Terminated - Clinical trials for Acute Lymphoid Leukemia

Donor-specific Allogeneic Hematopoietic Cell Transplantation for Acute Lymphoblastic Leukemia (ALL)

AHCTALL
Start date: January 2010
Phase: Phase 2
Study type: Interventional

[Study Objectives] - To evaluate the efficacy of allogeneic hematopoietic cell transplantation (HCT) in patients with acute lymphoblastic leukemia (ALL) in the first or second complete remission (CR). The efficacy of the treatment will be measured in terms of the frequency of relapse and duration of remission (the primary endpoints). - The secondary end points of the study include; engraftment, donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, transplantation-related mortality, leukemia free survival, and overall survival.

NCT ID: NCT01037556 Active, not recruiting - Clinical trials for Acute Myelogenous Leukemia

PR104 in Treating Patients With Refractory/Relapsed Acute Leukemia

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

The current understanding of PR104 justifies the evaluation of PR104 in subjects with relapsed/refractory AML and ALL. These include: - Hypoxia. Leukemic bone marrow is likely to demonstrate a level of hypoxia sufficient to activate PR104 to its active metabolites PR104H and PR104M. - Myelotoxicity as the primary toxicity at MTD. In prior clinical studies in subjects with solid tumors PR104 has demonstrated myelotoxicity as the primary toxicity. This observation suggests that PR104 will exert a similar effect on leukemic cells. - AKR1C3. AML has been reported to exhibit high levels of AKR1C3 which should lead to selective activation of PR104 within both hypoxic and oxic leukemic cells. - Preclinical data. PR104 has demonstrated impressive activity in an initial study using primary human ALL in a mouse model. The initial dose finding phase of the study will provide estimates of the activity and toxicity of PR104 in subjects with refractory/relapsed AML, and determine the optimal individualized dose to give each subject based on his/her covariates (prior CR duration, prior number of salvage therapies, age). Once a potentially beneficial dose has been determined, an expanded cohort of subjects with AML or ALL will receive PR104 at a uniform dose. This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity and acceptable safety in AML to warrant future phase II or phase III studies in this indication. Primary objectives - Determine the toxicities and recommended dose of PR104 when administered IV to subjects with relapsed/refractory AML and ALL. Secondary objectives - Evaluate the pharmacokinetics (PK) of PR104 and a series of PR104 metabolites - Evaluate any anti-tumor effects of PR104 - Evaluate the expression of AKR1C3 in bone marrow and leukemic cells - Evaluate potential biomarkers of hypoxia

NCT ID: NCT01036009 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies

Start date: October 2009
Phase: Phase 2
Study type: Interventional

There is no curative therapy once acute leukemia patients relapse after transplant. Patients who develop clinically significant graft versus host disease (GVHD) have a lower rate of relapse than those who do not develop GVHD. We are initiating this study of post-transplant fast withdrawal of immunosuppression and donor lymphocyte infusions, with a goal of achieving full donor chimerism in children with hematologic malignancies. If our hypothesis that full donor chimerism results in leukemia-free survival is correct, using immune modulation to achieve full donor chimerism should decrease relapse rate and thus increase survival. The goal of this Phase II study is to identify if achieving full donor chimerism in whole blood CD3+ and leukemia-specific (CD14/15+, CD19+, CD33+ and CD34+) subset may decrease the risk of relapse of patients undergoing allogeneic transplant for hematologic malignancy.

NCT ID: NCT01035216 Terminated - Leukemia Clinical Trials

A Phase I Study of GNKG168 in Patient With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Start date: September 2009
Phase: Phase 1
Study type: Interventional

This is an open-label, dose escalation study designed to characterize the safety, tolerability, efficacy, and pharmacokinetics of GNKG168 in patients with B-CLL that has relapsed or is refractory to all prior standard therapy, or for which no standard therapy exists.