Leukemia Clinical Trials

December 2013 - December 2015
The use of peripheral blood stem cells(PBSCs) is rapidly growing in the allogeneic transplantation setting as an alternative to bone marrow (BM).It was found that the use of PBSCs is associated with faster hematologic recovery but have yielded differing results regarding the incidence of graft-versus-host-disease (GVHD) and relapse. The study hypothesis: transplantation of mobilized PBSC to haploidentical donor with standard-risk leukemia had comparable engraftment and non-relapse mortality to mobilized BM combined with PBSCs Sponsor: Peking University People's Hospital

November 2013 -
The goal of this clinical research study is to learn if giving genetically changed immune cells, called T-cells, after chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied. The process of changing the DNA (the genetic material in cells) of these T-cells is called "gene transfer." Researchers want to learn if these genetically-changed T-cells are effective in attacking cancer cells in patients with leukemia, myelodysplastic syndrome (MDS), lymphoma, Hodgkin disease, or multiple myeloma (MM), after they have received an allogeneic stem cell transplant. The chemotherapy patients will be given on study is fludarabine, melphalan, and alemtuzumab. These drugs are designed to stop the growth of cancer cells, which may cause the cancer cells to die. This chemotherapy is also designed to block the body's ability to reject the donor's stem cells. Researchers also want to learn if giving AP1903 will help the symptoms of graft-versus-host disease (GvHD) that may occur after the T-cell infusion. GvHD occurs when donor cells attack the cells of the person receiving the stem cell transplant. Sponsor: M.D. Anderson Cancer Center

October 2013 -
The goal of this clinical research study is to learn about the safety and effects of giving special kinds of immune cells, called natural killer (NK) cells, with high dose chemotherapy to AML patients. Researchers want to learn the maximum tolerable number of NK cells that can be given. These NK cells may react against the leukemia cells, particularly when they are mismatched for certain HLA tissue type proteins. In addition to NK cells, you will receive cytarabine and fludarabine to try to kill any cancer cells and prevent rejection of the NK cells. Sponsor: M.D. Anderson Cancer Center

June 2013 -
The goal of this clinical research study is to find the highest tolerable dose of immune cells called natural killer (NK) cells that can be given with chemotherapy and a stem cell transplant to patients with AML and MDS. Researchers want to learn if adding NK cells will help make the stem cell transplant more effective in treating the disease. The safety of this treatment will also be studied. NK cells may kill cancer cells that remain in your body after your last chemotherapy treatment. The NK cells will be separated from blood from a relative of yours, from a matched unrelated donor, or from umbilical cord blood. These separated NK cells will then be grown in the lab to increase the number of NK cells that can be given to you by vein. The chemotherapy given on this study will consist of the following drugs: - Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants. - Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer cells to die. - IL-2 (interleukin-2) is a naturally occurring protein (cytokine) that can enhance NK cell function. Sponsor: M.D. Anderson Cancer Center

June 2013 - October 2016
To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years). Sponsor: Novartis

May 2013 -
The goal of this clinical research study is to learn if erlotinib can help to control AML. The safety of this drug will also be studied. Sponsor: M.D. Anderson Cancer Center

May 2013 -
The goal of this clinical research study is to learn if giving cells called natural killer (NK) cells after receiving fludarabine, melphalan, lenalidomide, and a UCB transplant can improve response in patients with CLL. The safety of this treatment and whether NK cells can lessen the risk of graft vs. host disease (GVHD) will also be studied. The first 3 patients enrolled on this study will not receive NK cells but will receive a cord blood transplant. UCB and NK cells may be able to kill leukemia cells that remain in your body after chemotherapy treatment. The UCB cells are also designed to increase blood production and strengthen your immune system. Fludarabine and melphalan are designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. Lenalidomide is being used in this study because it may increase the NK cell activity. Sponsor: M.D. Anderson Cancer Center

May 2013 -
The goal of this clinical research study is to learn the highest tolerable dose of phenethyl isothiocyanate (PEITC) that can be given to patients who have a lymphoproliferative disorder that has been treated with fludarabine. The safety of PEITC will also be studied. Sponsor: M.D. Anderson Cancer Center

May 2013 -
This is a 2 part study. The goal of the first part of this clinical research study is to find the highest tolerable dose of ruxolitinib that can be given with a TKI that patient is already taking (such as gleevec, sprycel, or tasigna) as part of their standard of care treatment. The goal of the second part of this study is to learn if this drug combination can help to control CML. Although patient has a good response to therapy, the disease is still detectable at low levels (this is called "minimal residual disease"). Researchers believe that eliminating all detectable evidence of disease may decrease the chances that the leukemia will ever come back. The safety of the drug combination will also be studied in both parts. Ruxolitinib is designed to block a protein called Jak2 that may help keep some leukemia cells alive even with TKI therapy. Blocking this protein may cause the cells to die. Sponsor: M.D. Anderson Cancer Center

April 2013 - April 2019
In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA) matched related/sibling donor (MSD) or matched unrelated donor (MUD) identified, will receive a killer-immunoglobulin receptors (KIR) mismatched haploidentical donor HCT with additional natural killer (NK) cells. The investigators anticipate enrollment of 55 donors and 55 recipients. PRIMARY OBJECTIVE: - To estimate the rate of successful engraftment at day +42 post-transplant in patients who receive KIR mismatched haploidentical donor stem cell plus NK cell transplantation with TLI based conditioning regimen for high risk hematologic malignancy. SECONDARY OBJECTIVES: - Estimate the incidence of malignant relapse, event-free survival, and overall survival at one-year post-transplantation. - Estimate incidence and severity of acute and chronic (GVHD). - Estimate the rate of transplant related mortality (TRM) in the first 100 days after transplantation. Sponsor: St. Jude Children's Research Hospital