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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR FLUDARA

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Clinical Trials for Fludara

Trial ID Title Status Sponsor Phase Summary
NCT00001832 Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma Completed National Cancer Institute (NCI) Phase 2 This experiment will test the safety and effectiveness of a treatment for melanoma in which certain lymphocytes (a type of white blood cell) are taken from the patient, grown in the laboratory, and returned after the patient's immune system has been weakened with immune-suppressing drugs. Some patients will also receive interleukin-2 (IL-2), a drug that may enhance the activity of the re-infused lymphocytes. Patients with metastatic melanoma (melanoma whose tumor has spread) who have been treated unsuccessfully with gp100 vaccination may participate in this study. They will undergo apheresis or a tumor biopsy, or both, to collect lymphocytes. In apheresis, whole blood is drawn through a needle in the arm. A machine separates the blood components and removes the white cells. The rest of the blood is returned to the donor through a needle in the other arm. A biopsy is a surgical procedure to remove a small piece of tumor tissue. Several weeks before the lymphocytes are collected, patients will receive injections of growth colony stimulating factor (G-CSF) every day for five days. This drug stimulates white cell production, permitting as many cells as possible to be obtained during collection. The lymphocytes will then be grown in larger numbers in the laboratory. Seven days before the cells are re-infused, the patient is admitted to the hospital and a catheter (small tube) is placed in a large vein in the chest or neck. Two drugs, cyclophosphamide and fludarabine, are given through the tube. These drugs suppress the immune system so that it will not interfere with the work of the reinfused lymphocytes. The lymphocytes are then injected through the catheter over a 30-minute period. After the infusion, patients who receive IL-2 will be given the drug in a high dose over a 15-minute period every eight hours for up to five days. Patients whose condition does not permit high-dose IL-2, such as those with a heart condition or lung problem, may receive a low-dose regimen, with the drug given as a shot under the skin of the thigh or abdomen for five days followed by a 2-day break, continuing for a total of six weeks. These patients receive a higher dose the first week and then half that dose the next five weeks. Blood and tissue samples will be taken before and during the study to evaluate the size of the tumor and assess treatment. If, 3-5 weeks after therapy is completed, the patient's tumor has stabilized or shrunk, the entire treatment, except for chemotherapy, may be repeated two more times.
NCT00034528 Stem Cell Transplantation After Reduced-Dose Chemotherapy for Patients With Sickle Cell Disease or Thalassemia Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 The purpose of this study is to find out if using a lower dose of chemotherapy before stem cell transplantation can cure patients of sickle cell anemia or thalassemia while causing fewer severe side effects than conventional high dose chemotherapy with transplantation.
NCT00038831 Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS Completed M.D. Anderson Cancer Center Phase 1/Phase 2 The goal of this clinical research study is to find the highest safe dose of Mylotarg that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation. Researchers will study the effects of this treatment combination on patients with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome. Primary Objective: 1. To determine the safety and maximum tolerated dose of Mylotarg as part of a reduced-intensity preparative regimen patients undergoing related, mismatched-related or matched unrelated donor transplantation. Secondary Objectives: 1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy. 2. To evaluate the incidence and severity of GVHD in this population 3. To evaluate disease-free and overall survival and relapse rates.
NCT00038844 Safety and Efficacy of Campath in Nonmyeloablative Transplantation Completed M.D. Anderson Cancer Center N/A Objective of the low-dose transplant regimen must produce the following effects: 1. Suppression of the patient's immune system to prevent rejection of the donor cells; 2. Control of the lymphoma. The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur.
NCT00038857 Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases Completed M.D. Anderson Cancer Center Phase 2 Donor: This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies. The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease [GvHD] (grade III-IV). Secondary objectives include assessments of recipient having donor derived platelet engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival, clinical safety and device performance of the CliniMACS CD34 selection device.
NCT00043810 Study of Gelonin Purging of Autologous Stem Cells for Transplantation Terminated M.D. Anderson Cancer Center Phase 1/Phase 2 Patients with Acute Myelogenous Leukemia or Myelodysplastic are able to achieve a complete remission but fail to achieve a prolonged disease-free survival. High dose chemotherapy and autologous bone marrow transplantation has been shown to be effective in this group of patients but hematopoietic recovery is slow, and infectious or bleeding complications are common. The delay in hematopoietic recover is accentuated by the use of purging techniques. This is a novel purging approach for autologous stem cell transplantation in patients with Acute Myelogenous Leukemia or Myelodysplastic syndrome to allow for rapid engraftment with a lower relapse rate therefore improving the therapeutic outcomes
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Fludara

Condition Name

Condition Name for Fludara
Intervention Trials
Leukemia 60
Lymphoma 32
Chronic Lymphocytic Leukemia 27
Myelodysplastic Syndrome 26
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Condition MeSH

Condition MeSH for Fludara
Intervention Trials
Leukemia 106
Leukemia, Lymphoid 63
Leukemia, Myeloid, Acute 58
Leukemia, Myeloid 58
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Clinical Trial Locations for Fludara

Trials by Country

Trials by Country for Fludara
Location Trials
United States 370
Japan 16
Canada 11
Australia 6
Denmark 6
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Trials by US State

Trials by US State for Fludara
Location Trials
Texas 92
Minnesota 38
New York 18
Maryland 18
Massachusetts 17
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Clinical Trial Progress for Fludara

Clinical Trial Phase

Clinical Trial Phase for Fludara
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Fludara
Clinical Trial Phase Trials
Recruiting 92
Completed 59
Terminated 25
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Clinical Trial Sponsors for Fludara

Sponsor Name

Sponsor Name for Fludara
Sponsor Trials
M.D. Anderson Cancer Center 81
National Cancer Institute (NCI) 33
Masonic Cancer Center, University of Minnesota 32
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Sponsor Type

Sponsor Type for Fludara
Sponsor Trials
Other 273
Industry 78
NIH 45
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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Chubb
Colorcon
McKesson
Express Scripts
Boehringer Ingelheim
McKinsey
Cantor Fitzgerald
Cerilliant

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