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Last Updated: January 22, 2021

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CLINICAL TRIALS PROFILE FOR CYCLOPHOSPHAMIDE

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505(b)(2) Clinical Trials for Cyclophosphamide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT01760226 Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Recruiting National Cancer Institute (NCI) N/A 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Recruiting Texas Children's Hospital N/A 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Recruiting Baylor College of Medicine N/A 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cyclophosphamide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000361 Autoimmunity in Inner Ear Disease Terminated National Institute on Deafness and Other Communication Disorders (NIDCD) Phase 3 1998-03-01 The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.
NCT00000420 Safety of Estrogens in Lupus: Birth Control Pills Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 3 1997-06-01 Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We will determine this by looking at the effects of oral contraceptives (birth control pills, also known as "the pill") on disease activity and severity in women with SLE. The results of the study will show whether it is safe for women with SLE to use the pill.
NCT00000420 Safety of Estrogens in Lupus: Birth Control Pills Completed Office of Research on Women's Health (ORWH) Phase 3 1997-06-01 Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We will determine this by looking at the effects of oral contraceptives (birth control pills, also known as "the pill") on disease activity and severity in women with SLE. The results of the study will show whether it is safe for women with SLE to use the pill.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cyclophosphamide

Condition Name

Condition Name for Cyclophosphamide
Intervention Trials
Breast Cancer 405
Lymphoma 354
Leukemia 297
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Condition MeSH

Condition MeSH for Cyclophosphamide
Intervention Trials
Lymphoma 761
Leukemia 603
Breast Neoplasms 574
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Clinical Trial Locations for Cyclophosphamide

Trials by Country

Trials by Country for Cyclophosphamide
Location Trials
United States 9,931
Canada 821
Australia 386
China 384
United Kingdom 331
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Trials by US State

Trials by US State for Cyclophosphamide
Location Trials
Texas 484
California 480
Maryland 465
New York 454
Illinois 324
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Clinical Trial Progress for Cyclophosphamide

Clinical Trial Phase

Clinical Trial Phase for Cyclophosphamide
Clinical Trial Phase Trials
Phase 4 85
Phase 3 549
Phase 2/Phase 3 85
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Clinical Trial Status

Clinical Trial Status for Cyclophosphamide
Clinical Trial Phase Trials
Completed 1035
Recruiting 765
Not yet recruiting 428
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Clinical Trial Sponsors for Cyclophosphamide

Sponsor Name

Sponsor Name for Cyclophosphamide
Sponsor Trials
National Cancer Institute (NCI) 853
M.D. Anderson Cancer Center 144
Children's Oncology Group 93
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Sponsor Type

Sponsor Type for Cyclophosphamide
Sponsor Trials
Other 3622
NIH 990
Industry 975
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