31 Graft-versus-Host-Disease 1 1 0 11 11 252 http://clinicaltrials.dfhcc.harvard.edu/trials/252 Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission RATIONALE: Giving chemotherapy, such as thiotepa and cyclophosphamide, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps 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 tacrolimus, methotrexate, and sirolimus after the transplant may stop this from happening. It is not yet known whether tacrolimus and methotrexate are more effective with or without sirolimus in preventing graft-versus-host disease. PURPOSE: This randomized phase III trial is studying tacrolimus, methotrexate, and sirolimus to see how well they work compared to tacrolimus and methotrexate in preventing graft-versus-host disease in young patients who are undergoing donor stem cell transplant for intermediate-risk or high-risk acute lymphoblastic leukemia in second complete remission. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- Phase 3 206 http://clinicaltrials.dfhcc.harvard.edu/trials/206 Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease The purpose of this research study is to determine the effectiveness of bortezomib (Velcade) plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this drug combination in this patient population. Chronic GVHD is a medical condition that may occur after allogeneic stem cell transplantation. The donor's immune system may recognize the participants body (the host) as foreign and attempt to "reject" it. Bortezomib has been used in other research studies, and information from those studies suggests that this drug may help to control the abnormal immune responses that underlie cGVHD. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- Phase 2 232 http://clinicaltrials.dfhcc.harvard.edu/trials/232 Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD) Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- Phase 2 349 http://clinicaltrials.dfhcc.harvard.edu/trials/349 UVB Phototherapy Treatment of Oral Chronic GVHD The purpose of this trial is to find out how effective Narrow Band-Ultraviolet Light B (NB-UVB) phototherapy is in treating oral cGVHD. NB-UVB Phototherapy involves exposing the inside of the mouth to light of a particular spectrum (a specific wavelength of light, 311nm) of the ultraviolet band, called NB-UVB. It is known that narrow band ultraviolet light therapy can improve symptoms in patients with skin chronic GVHD. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- Phase 2 186 http://clinicaltrials.dfhcc.harvard.edu/trials/186 Rituximab for Prevention of Chronic GVHD The purpose of this trial is to determine if administration of rituximab after allogeneic stem cell transplantation can reduce the incidence of chronic GVHD. Chronic GVHD is a medical condition that can occur after bone marrow or stem cells are transplanted form one individual to another. After the transplant, the donor immune system may recognize the recipient body as foreign and may attempt to "reject" the body. Rituximab is a drug that interferes with the immune system function by specifically targeting B cells and killing them. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- Phase 1/Phase 2 330 http://clinicaltrials.dfhcc.harvard.edu/trials/330 Bortezomib Plus Tacrolimus and Methotrexate to Prevent GVHD After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation The purpose of this study is to determine if Velcade (also known as bortezomib) can help prevent graft versus host disease (GVHD) developing after transplantation. This is done by using a combination of three immune suppressive medications: Velcade, tacrolimus and methotrexate. Stem cell transplantation is one of the options for patients with cancer of the blood or blood forming organs. Recently, allogeneic stem cell transplants have been performed using lower doses of chemotherapy and radiotherapy: non-myeloablative or "mini" transplants. GVHD is a significant problem that may occur even after "mini" transplantations. Information from other research studies, suggests that Velcade may help to reduce the risk of developing GVHD when given early after transplantation. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- Phase 1/Phase 2 31 http://clinicaltrials.dfhcc.harvard.edu/trials/31 Campath in Chronic GVHD The CD52 antigen, which is targeted by alemtuzumab, is highly expressed on mature T lymphocytes, monocytes and monocyte-derived dendritic cells as well as on mature B cells. Due to its more promiscuous effect on immune cells, alemtuzumab not only targets antibody producing B lymphocytes as does rituximab, but also targets alloreactive T lymphocytes and dendritic cells that also contribute to the complex pathogenesis of chronic GVHD. Our hypothesis is that alemtuzumab will be effective in the treatment of chronic GVHD through its promiscuous depletion of alloreactive T lymphocytes, dendritic cells as well as antibody producing mature B-lymphocytes. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- Phase 1 74 http://clinicaltrials.dfhcc.harvard.edu/trials/74 Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease The purpose of this research study is to determine the safety of IL-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (GVHD). Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize their body (the host) as foreign and attempt to "reject" it. Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to control chronic GVHD. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- Phase 1 796 http://clinicaltrials.dfhcc.harvard.edu/trials/796 Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying how well rasburicase works in preventing graft-versus-host disease in patients with hematologic cancer or other disease undergoing donor stem cell transplant. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- N/A 1183 http://clinicaltrials.dfhcc.harvard.edu/trials/1183 Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease- 1208 http://clinicaltrials.dfhcc.harvard.edu/trials/1208 Efficacy and Safety of Prochymal™ Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD This is a Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of Prochymal™ versus placebo in combination with corticosteroids as initial therapy for acute GVHD. Corticosteroids have been the primary therapy for patients with previously untreated acute GVHD and the historical published data define an expected 35% complete response (CR) at Day +28 using this therapy. Recruiting 31 Graft-versus-Host-Disease http://clinicaltrials.dfhcc.harvard.edu/diagnoses/31-graft-versus-host-disease-