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Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome Clinical research trials and Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome. Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome clinical trial. Human subjects often get the best healthcare available for their Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome  Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome
Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome
For Condition: Mycosis Fungoides,Sezary Syndrome
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: This study will investigate the safety and effectiveness of a modified donor stem cell transplantation procedure for treating advanced mycosis fungoides (MF), a lymphoma primarily affecting the skin, and Sezary syndrome (SS), a leukemic form of the disease. Donated stem cells (cells produced by the bone marrow that mature into the different blood components-white cells, red cells and platelets) can cure patients with certain leukemias and lymphomas and multiple myeloma. These cells generate a completely new, functioning bone marrow. In addition, immune cells from the donor grow and generate a new immune system to help fight infections. The new immune cells also attack any residual tumor cells left in the body after intensive chemotherapy. However, stem cell transplantation carries a significant risk of death, because it requires completely suppressing the immune system with high-dose chemotherapy and radiation. In addition, lymphocytes from the donor may cause what is called graft vs. host disease (GvHD), in which these cells see the patient's cells as foreign and mount an immune response to destroy them. To try to reduce these risks, patients in this study will be given low-dose chemotherapy and no radiation, a regimen that is easier for the body to tolerate and involves a shorter period of complete immune suppression. In addition, a monoclonal antibody called Campath-1H will be given to target lymphocytes, including those that have become cancerous. Patients with advanced MF or SS who are between 18 and 70 years of age and have a matched family donor 18 years of age or older may be eligible for this study. Candidates will have a medical history, physical examination and blood tests, lung and heart function tests, X-rays of the chest, eye examination, and bone marrow sampling (withdrawal through a needle of about a tablespoon of marrow from the hip bone), and small skin biopsy (surgical removal of a piece of tissue for microscopic examination) or needle biopsy of the tumor. Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF will be injected under the skin for several days to push stem cells out of the bone marrow into the bloodstream. Then, the stem cells will be collected by apheresis. In this procedure the blood is drawn through a needle placed in one arm and pumped into a machine where the required cells are separated out and removed. The rest of the blood is returned through a needle in the other arm. Before the transplant, a central venous line (large plastic tube) is placed into a major vein. This tube can stay in the body and be used the entire treatment period to deliver the donated stem cells, give medications, transfuse blood, if needed, and withdraw blood samples. Several days before the transplant procedure, patients will start a conditioning regimen of low-dose chemotherapy with Campath 1H, fludarabine, and, if necessary, cyclophosphamide. When the conditioning therapy is completed, the stem cells will be infused over a period of up to 4 hours. To help prevent rejection of donor cells and GvHD, cyclosporine and mycophenolate mofetil will be given by mouth or by vein for about 3 months starting 4 days before the transplantation. The anticipated hospital stay is 3 to 4 days, when the first 3 doses of Campath will be monitored for drug side effects. The rest of the procedures, including the transplant, can be done on an outpatient basis. Follow-up visits for the first 3 months after the transplant will be scheduled once or twice a week for a physical examination, blood tests and symptoms check. Then, visits will be scheduled at 6, 12, 18, 24, 30, 36, and 48 months post-transplant. Visits for the first 3 years will include blood tests, skin biopsies, and bone marrow biopsies.
Details: Primary cutaneous T-cell lymphomas (CTCL) are a group of lymphoproliferative disorders characterized by localization of neoplastic T cells to the skin at presentation. Mycosis fungoides (MF) and its leukemic variant Sezary syndrome (SS) are the most prevalent forms of CTCL. While early stage MF is restricted to patches and plaques involving the skin, most patients eventually develop cutaneous tumors, generalized erythroderma, or dissemination to peripheral blood, lymph nodes or visceral organs. Currently existing therapy of tumor-stage and disseminated CTCL is palliative, with most patients dying within 1-5 years. The presence of CD8+ cells in close proximity to dermal neoplastic infiltrates in early stages of the disease, and the clinical response seen with some immunomodulatory agents suggests that CTCL may be potential targets for immunotherapy-based interventions. Allogeneic stem cell transplantation is a curative treatment modality successfully employed in a number of hematologic malignancies. The curative effect of this approach is in part mediated by donor-derived T lymphocytes with reactivity for patient leukemic cells. The power of this graft versus leukemia effect (GVL) is best illustrated in patients with relapsed CML after an allogeneic bone marrow transplant, in whom a single donor lymphocyte infusion can induce remission. We hypothesize that neoplastic T cells in MF/SS may similarly be susceptible to a graft vs tumor (GVT) effect. Unfortunately, advanced patient age and a 25% to 35% risk of transplant related mortality (TRM) preclude the use of conventional 'dose- intensive' allogeneic peripheral blood stem cell transplantation (PBSCT) in patients with advanced CTCL who might otherwise benefit from this approach. The risk of TRM related to conditioning can be circumvented at least partially by using a reduced-intensity conditioning regimen to prepare the patient for transplantation. In this study, we will treat male and non-pregnant female patients between the ages of 18 and 70 years suffering from advanced MF/SS with an allogeneic peripheral blood stem cell transplant from an HLA-identical sibling. A low intensity, nonmyeloablative conditioning regimen employing the anti-CD52 monoclonal antibody Campath-1H and fludarabine +/- cyclophosphamide will be used to induce host immunosuppression to facilitate donor hematopoietic and lymphoid engraftment. We anticipate minimal host myelosuppression and consequently reduced early transplant toxicity with this conditioning regimen. Immune and hematopoietic reconstitution will be achieved by infusion of unmanipulated donor-derived granulocyte colony stimulation factor (G-CSF) mobilized peripheral blood stem cells (PBSC). The conditioning regimen will be dose-escalated in a phase I fashion should stable donor engraftment be <80%. Infusions of donor lymphocytes in incremental doses will be used to promote engraftment or disease regression when indicated. Cyclosporine A will be used as prophylaxis against graft vs host disease (GVHD), with dose adjustments made as necessary to favor complete donor chimerism and disease regression. A total of up to 58 patients will be treated on this protocol. The primary end point of this study is engraftment. Other end points include assessment of donor-host chimerism in various hematopoietic and lymphoid cells, disease response, incidence of acute and chronic GVHD, graft failure, assessment of lymphoid subset reconstitution, transplant related morbidity and mortality and disease-free and overall survival.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: RECIPIENT: Ages 18-70 years Stages IIb to IVb patients with MF (biopsy diagnostic or consistent with MF) who have progressed despite at least one treatment regimen and all patients with SS AND anticipated median survival less than 5 years or debilitation as a result of their disease. No prior treatment for MF/SS within 30 days HIV negative ECOG performance status of 1 or less. No major organ dysfunction precluding transplantation. DLCO greater than or equal to 60 percent predicted Left ventricular ejection fraction greater than or equal to 40 percent. Less than 25 percent of liver involved with metastatic tumor by CT scan. 6/6 HLA matched family donor available Ability to comprehend the investigational nature of the study and provide informed consent. Durable power of attorney signed DONOR: 6/6 HLA- matched family donor Age greater than or equal to 18 years Fit to receive G-CSF and give peripheral blood stem cells (normal blood counts, normotensive, no history of stroke) Ability to comprehend the investigational nature of the study and provide informed consent. EXCLUSION CRITERIA (ANY OF THE FOLLOWING): PATIENT: Patient pregnant or lactating Age greater than 70 or less than 18 years ECOG performance status of 2 or more. Psychiatric disorder or mental deficiency of the patient or donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible. Major anticipated illness or organ failure incompatible with survival from BMT and where survival is considered insufficient to assess transplant outcome (i.e. less than 3 months). DLCO less than 60 percent predicted Left ventricular ejection fraction less than 40 percent Serum creatinine greater than 2.0 mg/dl Serum bilirubin greater than 4 mg/dl, transaminases greater than 5x upper limit of normal HIV positive History of other malignancies in the last five years with the exception of basal cell or squamous carcinoma of the skin Disease which is not evaluable either clinically or radiographically Evidence for CNS metastatic disease Disease involving greater than 25 percent of the liver radiographically. DONOR: Donor pregnant or lactating Age less than 18 years HIV positive (donors who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-1) will be used at the discretion of the investigator following counseling and approval from the recipient). History of malignancy within 5 years except basal cell or squamous carcinoma of the skin. Donor unfit to receive G-CSF and undergo apheresis (Uncontrolled hypertension, history of stroke, thrombocytopenia).
Total Enrollment: 58
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020250; 02-H-0250
Study Start Date: July 30, 2002
Record last reviewed: July 10, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042640
Other Sezary Syndrome Studies:
1. Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients.
2. Study of T Cell Genes in Patients with Sezary Syndrome and Mycosis Fungoides
3. Open label study of ONTAK (denileukin diftitox) in previously treated Cutaneous T-cell Lymphoma patients.
4. Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome
Related Studies:
Other Sezary Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Stem Cell Transplant Therapy with Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome
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