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Aplastic Anemia Clinical Trials

The following clinical research studies being conducted for patients with aplastic anemia. The information is offered to patients as a resource, not as an endorsement of any treatment, doctor, or medical center.

Bone Marrow Transplant Clinical Trials Network, Multiple Locations
Fludarabine-based Conditioning for Allogenic Marrow Transplantation From HLA-compatible Unrelated Donors in Severe Aplastic Anemia
BMT CTN 0301. This is a phase I/II trial using fludarabine, cyclophosphamide, total body irradiation, and ant-thymocyte globulin (ATG) to evaluate the efficacy of fludarabine and lower the dose of cyclophospahmide in patients with severe aplastic anemia who require an unrelated donor bone marrow transplant. The addition of fludarabine should improve engraftment and lowering the dose of cyclophosphamide may reduce transplant-related complications thereby improving survival. Eligible patients must have a suitable matched unrelated donor, be less than 65 years of age and have severe aplastic anemia. Contact Dr. Paolo Anderlini, Principal Investigator at panderli@mdanderson.org. For more information about this protocol, eligibility criteria, and a list of locations, visit http://spitfire.emmes.com/. 11/2005

Case Western Reserve University, Ireland Cancer Center, Cleveland, Ohio
Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia
CWRU-5Y97. This is a phase II trial using unrelated umbilical cord blood to evaluate the efficacy of allogeneic transplantation for MDS and Severe Aplastic Anemia. Patients with MDS or Severe Aplastic Anemia who require allogeneic transplant and are eligible to receive full myeloablative conditioning with busulfan and cyclophosphamide. Eligible patients must have MDS or SAA and have failed medical therapy. Contact Mary J. Laughlin, MD, Principal Investigator, at 216.368.5693 or mjl13@case.edu. 11/2005

Case Western Reserve University, Ireland Cancer Center, Cleveland, Ohio
Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders
CWRU 6Y01. This is a phase I trial using Umbilical Cord Blood to evaluate the efficacy of Allogeneic Transplantation to treat myelodysplastic syndrome or Severe Aplastic Anemia. The rationale for this study is to investigate whether transplantation of more than one UCB unit is safe and whether this approach may overcome the current problems of primary graft failure and delayed engraftment with single unit UCB. This concept will be evaluated in the setting of non-myeloablative conditioning in attempt to decrease the risk of mortality in the event of primary graft failure. Eligible patients must have hematologic cancer including MDS or Severe Aplastic Anemia requiring allogeneic transplantation. Contact Mary J. Laughlin, MD, Principal Investigator, at 216.368.5693 or mary.laughlin@case.edu. 11/2005

Duke University Medical Center, Durham, North Carolina
Phase II Trial of Non-Myeloablative Allogeneic Transplantation
2875. Our trial is a phase I-II trial to assess the value of non-myeloablative allogeneic therapy (mini bone marrow transplant) for patients with aplastic anemia or myelodysplastic syndromes. Patients must have severe disease to be eligible and may have either a matched sibling, mismatched family member, or large cord blood unit found for use on our trial. Contact David A. Rizzieri, MD at Rizzi003@mc.duke.edu. 11/2005

Fred Hutchinson Cancer Research Center, Seattle, Washington
Conditioning Regimens for Patients with Severe Aplastic Anemia Transplanted with Marrow from an Unrelated Donor
FHCRC #800. This is a phase I/II trial. Patients with severe aplastic anemia who do not have HLA-matched related donor and who have failed immunosuppressive therapy. A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan plus ATG and the TBI dose is escalated or de-escalated dependent upon engraftment and toxicity. Eligible patients must have severe aplastic anemia without sustained response to immunosuppressive therapy. Contact: H.J. Deeg, MD at 206.288.1024. Contact: Clinical Coordinator's Office 206.288.1024. 11/2005

Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York
Phase II Study of Allogeneic Umbilical Cord and Placental Blood Transplantation in Patients with Chronic Myeloid Leukemia, Acute Leukemia, Lymphoma, Myeloma, Myelodysplasia, Aplastic Anemia, Fanconi's Anemia, Histiocytosis, Hereditary Immunodeficiency, or Storage Disorder
CAMP 21 (CHNY 01-514). This is a phase II trial using umbilical cord blood transplant with standard myeloablative conditioning regimens to evaluate the efficacy of this alternative stem cell source to treat hematologic malignancies, myelodysplastic syndrome, and aplastic anemia. Eligible patients must have physiologic age less than 60 years; eligible for standard allogeneic stem cell transplant but lacking a suitable marrow or peripheral blood stem cell donor; no serious infections, seronegative for HIV, hepatitis B, and hepatitis C; serum bilirubin less than twice normal and no other evidence of severe liver disease; serum creatinine less than twice normal for age; no other serious medical or psychiatric illness; and having available a cord blood unit from an established storage center or family donor which is mismatched for 0, 1, or 2 HLA loci, contains at least 1 x 10E7 nucleated cells per kg ideal body weight of recipient, and is seronegative for HIV, hepatitis B, and hepatitis C. This is a single location trial. For more information contact David G. Savage, MD, Principal Investigator at 212.305.9783 or dgs5@columbia.edu or James H. Garvin, MD, PhD, Co-Investigator, Columbia University Medical Center, at 212.305.5872 or jhg1@columbia.edu. 11/2005

M.D. Anderson Cancer Center, Houston, Texas
A Randomized Three Arm Study of ATG versus ATG + Fludarabine versus ATG + Cyclosporine A to Treat Myelodysplastic Syndrome
ID99-059. This is a phase II trial using ATG/CSA; ATG/Fludarabine to evaluate the efficacy of immunosuppression to treat aplastic anemia and myelodysplastic syndromes patients. Eligible patients must have MDS of subtype RA, blasts < 5% in bone marrow that require > unit of PRBC/month for > 2 months, platelet count < 50,000/m3, or neutrophil count < 500/m3, IPSS score >2. Contact Jeffery Molldrem, MD or Rosa Rios, RN at 713.792.7346 or jmolldre@mdanderson.org. 11/2005

M.D. Anderson Cancer Center, Houston, Texas
A Pilot Study of Purine Analog-based Conditioning for Unrelated Donor Stem Cell Transplantation in Patients with Severe Aplastic Anemia
IDP00-266. This is a pilot trial using reduced-intensity conditioning ("minitransplant") to evaluate the efficacy of allogeneic marrow transplant to treat aplastic anemia unresponsive to immunosuppression; HLA-compatible related or unrelated donor; good general conditions. Contact Paolo Anderlini,MD at panderli@mdanderson.org. 11/2005

M.D. Anderson Cancer Center, Houston, Texas

Phase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and GCSF in Patients with Newly Diagnosed Aplastic Anemia or with Hypoplastic Myelodysplastic Syndrome

MDA 2005-0115. This is a phase II trial using Thymoglobulin and Cyclosporine to evaluate the efficacy of Thymoglobulin and Cyclosporine to treat severe aplastic anemia and hypoplastic MDS. Patients with previously untreated severe aplastic anemia or hypoplastic MDS (with bone marrow cellularity less than 30%) who have adequate liver and kidney function are eligible to participate. Contact Dr. Farhad Ravandi at 713.745.0394 or fravandi@mdanderson.org. 11/2005

National Heart, Lung, and Blood Institute (NHLBI), Bethesda, Maryland
Hepatitis-Associated Aplastic Anemia
03-H-0051. Researchers at the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), a part of the Department of Health and Human Services (DHHS) are conducting laboratory studies on blood, bone marrow, stool and/or liver tissue samples from subjects with hepatitis-associated aplastic anemia to improve our understanding of the disease and possibly identify one or more causative viral agents. If you or someone you know has been diagnosed with hepatitis-associated aplastic anemia you may be able to participate in this clinical trial. To find out if you qualify, please contact Olga Nunez at 301.496.4462 or email us at nunezo@nih.gov. 11/2005

National Heart, Lung, and Blood Institute (NHLBI), Bethesda, Maryland
Peripheral Blood Stem Cell Transplant (PBSCT) for Patients with Aplastic Anemia
99-H-0050. If you have been diagnosed with aplastic anemia or paroxysmal nocturnal hemoglobinuria (PNH), you may be able to participate in a stem cell transplant clinical trial designed to evaluate methods to decrease graft versus host disease, promote engraftment, and improve immune system recovery following a bone marrow stem cell transplant procedure. You must have an HLA-matched family member to participate. You will be given chemotherapy followed by a transfusion of stem cells and lymphocytes from your donor, which will replace your immune system with the immune system of your healthy donor. Post transplant therapy is designed to reduce the risk of graft versus host disease. We do the blood testing free of charge to see if your family member is a match. We pay for all medical costs related to the transplant procedure. You must be available to live near NIH for approximately 3 months. We also provide a daily allowance to help with living expenses while you are on the study and living away from home. To find out if you qualify, please contact Rose Goodwin at 301.594.8013. 11/2005

National Heart, Lung, and Blood Institute (NHLBI), Bethesda, Maryland
Daclizumab for Aplastic Anemia
00-H-0029. If you or someone you know has been diagnosed with aplastic anemia you may be able to participate in a clinical trial evaluating a new immunosuppressive therapy. Hematologists are evaluating whether daclizumab, a genetically engineered human monoclonal antibody, can increase blood counts, reduce anemia symptoms, and/or reduce dependence on immunosuppressive medications and transfusions. This protocol now only accrues for moderate aplastic anemia and pure red cell aplasia. To find out if you qualify, please contact Barbara Weintein at 301.594.4180 or email us at nunezo@nih.gov. 11/2005

National Heart, Lung, and Blood Institute, Bethesda, Maryland
Alemtuzumab (Campath®) for Refractory or Relapsed Severe Aplastic Anemia
05-H-0242. Hematologists at the National Heart, Lung, and Blood Institute are investigating a new treatment for severe Aplastic Anemia. The study drug, a monoclonal antibody, may help increase blood counts, reduce anemia symptoms, and/or reduce dependence on transfusions. If eligible to participate, consenting subjects will receive an intravenous infusion of study medication alemtuzumab (Campath®) once a day for 10 days. Subjects will be admitted to the NIH Clinical Center hospital for study drug initiation. If the study drug infusion is tolerated well, the subject may be discharged and receive the remainder of the treatment course as an outpatient. If you have been diagnosed with SAA and have received prior immunosuppressive therapy and have either failed to respond or have relapsed following treatment, you may be able to participate in this clinical trial. To find out if you qualify, please call our study coordinator at 301.496.4462 or email us at Bloodstudy@nhlbi.nih.gov. 11/2005

National Heart, Lung, and Blood Institute, Bethesda, Maryland
Rituximab (Rituxan®) for Moderate Aplastic Anemia
05-H-0244. If you or someone you know has been diagnosed with aplastic anemia you may be able to participate in a clinical trial evaluating a new immunosuppressive therapy. Hematologists are evaluating whether rituximab (Rituxan®), a genetically engineered monoclonal antibody therapy, can increase blood counts, reduce anemia symptoms, and/or reduce dependence on immunosuppressive medications and transfusions. If you are determined eligible to participate, you will be treated with an infusion of rituximab once every week for a total of 4 doses and then followed to evaluate for response. This protocol is also for Diamond Blackfan Anemia and Pure Red Cell Aplasia. To find out if you qualify, please contact our research coordinator Barbara Weinstein, RN at 301.594.4180 or email us at Bloodstudy@nhlbi.nih.gov. 11/2005

National Heart, Lung, and Blood Institute (NHLBI), Bethesda, Maryland
Feasibility of Stem Cell Mobilization in Patients with Severe Aplastic Anemia
01-H-0083. If you have been diagnosed with aplastic anemia, successfully treated with immunosuppressive drugs, and are now in remission, you may be eligible to participate in a study evaluating the feasibility of mobilizing and harvesting your blood stem cells. Under evaluation is the ability to collect sufficient number of stem cells from recovered aplastic anemia patients. If successful, your stem cells will be frozen and may be given back to you on another research study should your disease return. Patients will under go a complete history and physical exam, blood tests, up to 10 days of daily injections of G-CSF under the skin, and a procedure to collect the stem cells. Eligible patients are not asked to pay for their medical treatment, hospital costs, or stem cell storage fees. To find out if you qualify, please contact Olga Nunez at 301.496.4462 or email us at nunezo@nih.gov. 11/2005

National Heart, Lung, and Blood Institute (NHLBI), Bethesda, Maryland
Randomized Trial of Campath versus r-ATG/CsA for Severe Aplastic Anemia
03-H-0249. Researchers at the National Heart, Lung, and Blood Institute of the National Institutes of Health, a part of the Department of Health and Human Services, are investigating a new method of treatment for severe aplastic anemia. Hematologists are comparing the effectiveness of a new immunosuppressive treatment (Campath-1H) with rabbit ATG and Cyclosporine (CsA) therapy for patients with severe aplastic anemia. The study may help increase blood counts, reduce anemia symptoms, and/or reduce dependence on immunosuppressive medications and transfusions. If you are determined eligible to participate, you will be selected by a process based on chance to receive either (1) Campath-1H for 10 days or (2) rabbit ATG for 5 days + CsA for 6 months. If you have been diagnosed with severe aplastic anemia and are over the age of 2, you may be able to participate in this clinical trial. This protocol is for patients who have received treatment with horse ATG and have not responded or have had minimal response. To find out if you qualify, please contact Olga Nunez at 301.496.4462 or email us at nunezo@nih.gov. 11/2005

New York – Presbyterian Hospital, New York, New York
CHNY 01-509. This is a phase II trial using fludarabine, cyclophosphamide, and Thymoglobulin (anti-thymocyte globulin) to evaluate the efficacy of reduced-intensity allogeneic stem cell transplant to treat aplastic anemia. Eligible patients must have 1) severe aplastic anemia; 2) age less than 56 years; 3) adequate organ function; 4) matched family donor (6/6 or 5/6), unrelated donor(6/6 or 5/6), related or unrelated cord blood. Contact James Garvin, MD at 212.305.5808 or jhg1@columbia.edu. 11/2005

Roswell Park Cancer Institute, Buffalo, New York
Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Aplastic Anemia or Hematologic Cancer
NCT00003816. This is a phase II/III trial to determine safety and toxicity of this form of treatment in a patient population that is usually not eligible for full myeloblative allogeneic transplant. To evaluate the evidence of graft versus host disease effect, graft versus host disease, chimerism of non-myeloblative peripheral blood stem cell transplantation, cord blood transplantation for the treatment of hematological malignancies in aplastic anemia. For more information call 716-845-8707 or contact Philip McCarthy, MD, Principal Investigator at philp.mccarthy@roswellpark.org, Dorothy Macchio at dorothy.macchio@roswellpark.org, or Joyce Yasko at joyce.yasko@roswellpark.org. 11/2005

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland
High Dose Cyclophosphamide For Severe Aplastic Anemia (SAA) and Paroxysmal Nocturnal Hemoglobinuria (PNH)
JHOC-9611. Newly diagnosed and previously treated patients with SAA are eligible for this NIH-sponsored phase II clinical trial. PNH patients with severe cytopenias and/or thrombosis are also eligible for the trial. When used as first-line therapy for SAA more than 70% of patients have achieved a durable remission. High-dose cyclophosphamide can also salvage patients who have relapsed or are unresponsive to ATG and cyclosporine. Patients up to age 70 years old are eligible for the trial. Contact Richard J. Jones at 410-955-2813 or Robert Brodsky, MD at 410.614.2809. 11/2005

St. Jude Children's Research Hospital, Memphis, Tennessee
Partially Matched Stem Cell Transplantation for Patients with Refractory Severe Aplastic Amenia or Refractory Cytopenias
SAAHAP. This protocol involves hematopoietic stem cell transplantation for children (>21 years old) with refractory severe aplastic anemia (failure to respond to intensive immunosuppression that includes ATG within 6 months), Kostmann syndrome refractory to G-CSF, Diamond-Blackfan anemia refractory to corticosteroids and/or cyclosporine, or amegakaryocytic thrombocytopenia. Patients with one of these conditions who lack HLA-matched sibling donors or 10/10 allele-matched unrelated donors are eligible. The donor source is mismatched parental donors. Principal Investigator is Paul Woodard, M.D. Contact 866.278.5833 or info@stjude.org for more information and eligibility requirements. 12/2005


Additional listings

ClinicalTrials.gov: Studies for aplastic anemia patients (United States) – www.clinicaltrials.gov

ClinicalTrials.gov: Studies for aplastic anemia patients (U.S. and non-U.S.) – www.clinicaltrials.gov


 

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