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Last Updated: June 26, 2022

CLINICAL TRIALS PROFILE FOR DELTASONE


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505(b)(2) Clinical Trials for Deltasone

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 Completed National Cancer Institute (NCI) Early Phase 1 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 Completed Texas Children's Hospital Early Phase 1 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 Completed Baylor College of Medicine Early Phase 1 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.
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Deltasone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002618 ↗ Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma Completed National Cancer Institute (NCI) Phase 3 1994-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00002618 ↗ Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma Completed Children's Oncology Group Phase 3 1994-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00003389 ↗ Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma Completed National Cancer Institute (NCI) Phase 3 1999-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.
NCT00003389 ↗ Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma Completed Eastern Cooperative Oncology Group Phase 3 1999-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Deltasone

Condition Name

Condition Name for Deltasone
Intervention Trials
Acute Lymphoblastic Leukemia 15
Lymphoma 15
Leukemia 13
Prostate Cancer 13
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Condition MeSH

Condition MeSH for Deltasone
Intervention Trials
Lymphoma 58
Prostatic Neoplasms 38
Leukemia 36
Precursor Cell Lymphoblastic Leukemia-Lymphoma 34
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Clinical Trial Locations for Deltasone

Trials by Country

Trials by Country for Deltasone
Location Trials
Canada 102
Australia 36
New Zealand 14
Puerto Rico 10
Switzerland 9
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Trials by US State

Trials by US State for Deltasone
Location Trials
Texas 66
California 56
New York 53
Illinois 48
Ohio 45
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Clinical Trial Progress for Deltasone

Clinical Trial Phase

Clinical Trial Phase for Deltasone
Clinical Trial Phase Trials
Phase 4 6
Phase 3 29
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Deltasone
Clinical Trial Phase Trials
Completed 48
Recruiting 45
Active, not recruiting 32
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Clinical Trial Sponsors for Deltasone

Sponsor Name

Sponsor Name for Deltasone
Sponsor Trials
National Cancer Institute (NCI) 94
M.D. Anderson Cancer Center 24
Children's Oncology Group 11
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Sponsor Type

Sponsor Type for Deltasone
Sponsor Trials
Other 150
NIH 98
Industry 78
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