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Fish and Richardson
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Harvard Business School
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Generated: November 15, 2018

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CLINICAL TRIALS PROFILE FOR DEXAMETHASONE

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Clinical Trials for Dexamethasone

Trial ID Title Status Sponsor Phase Summary
NCT00000563 Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. Secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care.
NCT00000621 Feasibility of Retinoic Acid Treatment in Emphysema (FORTE) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 To conduct feasibility studies on the use of retinoids in the treatment of emphysema. Specific objectives are to identify optimal patient populations, retinoids, doses, dosing schedules, routes of administration, and outcome measures preparatory to conducting a larger, controlled, clinical trial on the efficacy of retinoid therapy in the management of emphysema.
NCT00000658 A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma Completed Schering-Plough Phase 3 To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000658 A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000689 Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 To determine the toxicity and effectiveness of adding sargramostim (recombinant granulocyte-macrophage colony stimulating factor; GM-CSF) to a standard chemotherapy drug combination (methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone) known as mBACOD in the treatment of non-Hodgkin's lymphoma in patients who are infected with HIV. Treatment of patients with AIDS-associated lymphoma is achieving inferior results when compared with outcomes for non-AIDS patients. Treatment with mBACOD has been promising, but the toxicity is very high. Patients treated with mBACOD have very low white blood cell counts. GM-CSF has increased the number of white blood cells in animal studies and preliminary human studies. It is hoped that including GM-CSF among the drugs given to lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Dexamethasone

Condition Name

Condition Name for Dexamethasone
Intervention Trials
Multiple Myeloma 446
Leukemia 89
Lymphoma 81
Acute Lymphoblastic Leukemia 43
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Condition MeSH

Condition MeSH for Dexamethasone
Intervention Trials
Multiple Myeloma 639
Neoplasms, Plasma Cell 614
Lymphoma 209
Leukemia 199
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Clinical Trial Locations for Dexamethasone

Trials by Country

Trials by Country for Dexamethasone
Location Trials
Canada 536
Netherlands 87
Belgium 70
Brazil 63
Poland 60
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Trials by US State

Trials by US State for Dexamethasone
Location Trials
Texas 321
New York 304
California 288
Massachusetts 233
Florida 207
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Clinical Trial Progress for Dexamethasone

Clinical Trial Phase

Clinical Trial Phase for Dexamethasone
Clinical Trial Phase Trials
Phase 4 281
Phase 3 433
Phase 2/Phase 3 42
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Clinical Trial Status

Clinical Trial Status for Dexamethasone
Clinical Trial Phase Trials
Completed 794
Recruiting 516
Active, not recruiting 240
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Clinical Trial Sponsors for Dexamethasone

Sponsor Name

Sponsor Name for Dexamethasone
Sponsor Trials
National Cancer Institute (NCI) 244
M.D. Anderson Cancer Center 121
Celgene Corporation 115
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Sponsor Type

Sponsor Type for Dexamethasone
Sponsor Trials
Other 2448
Industry 965
NIH 302
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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Chinese Patent Office
Covington
Johnson and Johnson
Teva
Cipla
Deloitte
Mallinckrodt
Dow

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