View clinical trials related to Myelodysplastic Syndrome.
Filter by:T-cell and B-cell depletion in allogeneic peripheral blood stem cell transplantation by using immunomagnetic negative and positive selection procedures Background: Removal of T-cells from the donor graft (T-cell depletion) offers the possibility for prevention of GVHD and subsequently less transplant related morbidity and mortality after allogeneic stem cell transplantation (SCT). There are several techniques to deplete T-cells from the stem cell grafts e.g. physical, immunological and combined physical / immunological separation methods. All these techniques result in a stem cell graft with sufficient CD34+ stem cells combined with an adequate depletion of T and B cells. CD34+ selected stem cell grafts are very pure and do not contain any additional cell populations. In contrast, CD3+/CD19+ depleted grafts still contain NK-cells, monocytes and dendritic cells that are part of the innate immune system. Theoretically,the presence of these cells may positively influence immunological reconstitution and the graft-versus-leukaemia (GVL) effect, respectively, resulting in improved outcome after SCT Objectives: To evaluate the differences in immunological reconstitution, transplant related mortality, disease-free survival and overall survival after T-cell depleted allogeneic SCT for haematological malignancies using either immunomagnetic CD34+ selection or immunomagnetic CD3+/CD19+ depletion using the CliniMACS system in approximately 270 consecutive patients. Additionally in this study in 20 consecutive patients the kinetics of NK-cel reconstitution and differences in NK-cell repertoire will be monitored. NK-cell mediated anti-tumor reactivity will be monitored in patients transplanted with and without NK-cells in the stem cell graft (CD3+/CD19+ depletion, versus CD34+ selection). Secondary objectives are to evaluate the clinical relevance of minor histocompatibility-specific cytotoxic T-cell responses for the GVL effect, the kinetics of NK-cell reconstitution and differences in NK-cell repertoire using the different T-cell depletion protocols. Design: Single center prospective randomised phase III study Population: Patients eligible for allogeneic SCT according to the standard criteria of our institution who will receive an allogeneic T- and B-cell depleted SCT with peripheral stem cells of an HLA-identical sibling donor or an HLA-identical unrelated voluntary (VUD) donor. Intervention: T-cell depletion will be conducted using two different techniques: either immunomagnetic CD34+ selection or immunomagnetic CD3+/CD19+ depletion. Endpoints: Primary endpoints are immunological reconstitution, relapse, disease free survival and overall survival. Secondary endpoints: NK-cell reconstitution and NK-cell mediated anti-tumour reactivity. Cytotoxic T-cell responses for the GVL effect. Estimated efforts and risks for participating patients: We don't expect any extra patient efforts or risks because T-cell depletion is a standard procedure in our clinic for many years. There is extensive experience with immunological T-cell depletion techniques. We hypothesize CD3+/CD19+ depletion will favour stem cell transplant outcome. Immunological and molecular biological studies will be performed on blood samples already obtained as part of the standard protocol.
Primary Objective: A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus and MMF. B. To evaluate the incidence of grade II-IV GVHD associated with this treatment.
About 90% of patients with haemato-oncologic malignancy lose their body muscle mass and also lose weight either due to chemotherapy induced nausea/vomiting or the high catabolic state due to fever, sepsis or chemotherapy. This impacts tremendously on the days in hospital and also on the treatment-related complications. Studies with Human Growth hormone (hGH) have shown that it increases lean body mass in adult patients with AIDS and animal models of cancer. At the same time, in vitro studies have shown that hGH has no effect on tumor cell growth. This study is designed to see if the use of hGH in immunocompromised patients with haematological malignancies prevents the loss of muscle mass and weight loss to some extent. This will be a blinded 1:1, randomised study including 150 patients whereby the patients will either receive hGH or a placebo. The doctors and the nurses will not know what drug the patient is receiving. Both hGH and the placebo will be given intravenously (if patients are receiving other intravenous antibiotics or haemopoietic support ) or subcutaneously (if platelets are above 20 x 109/L) The treatment will start on the first day of treatment and continue for 6 weeks.
The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.
The goal of this clinical research study is to learn if clofarabine given by mouth on a weekly schedule can help to control MDS. The safety of clofarabine given by mouth will also be studied.
The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and CMV-seropositive recipient-only subjects (related or unrelated) to determine incidence rates of CMV infection, disease, and other complications from immunosuppression and/or transplantation. The outcomes for the groups receiving CMV vaccine will be compared to the outcomes for the group that received the placebo vaccine to see if there is a clinical benefit. For this trial, donors and recipients must have matched HLA genotype (matched at 5/6 or 6/6 HLA loci).
Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.
The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).
The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia.
The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.