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Last Updated: August 14, 2020

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CLINICAL TRIALS PROFILE FOR NEOSAR

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505(b)(2) Clinical Trials for Neosar

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
OTC NCT03742258 Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Not yet recruiting National Cancer Institute (NCI) Phase 1 2018-12-29 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 your disease. Other objectives include measuring the amount of the study drug in your body at different times after taking the study drug. Your participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. You will receive the study treatment for up to 18 weeks, as long as you are benefitting.
OTC NCT03742258 Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Not yet recruiting Northwestern University Phase 1 2018-12-29 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 your disease. Other objectives include measuring the amount of the study drug in your body at different times after taking the study drug. Your participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. You will receive the study treatment for up to 18 weeks, as long as you are benefitting.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Neosar

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002836 Filgrastim Plus Chemotherapy Compared With Filgrastim Alone In Treating Women Undergoing Peripheral Stem Cell Transplantation For Breast Cancer Completed National Cancer Institute (NCI) Phase 3 1995-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus filgrastim with filgrastim alone in treating women undergoing peripheral stem cell transplantation for stage II, stage III, or metastatic breast cancer.
NCT00002836 Filgrastim Plus Chemotherapy Compared With Filgrastim Alone In Treating Women Undergoing Peripheral Stem Cell Transplantation For Breast Cancer Completed M.D. Anderson Cancer Center Phase 3 1995-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus filgrastim with filgrastim alone in treating women undergoing peripheral stem cell transplantation for stage II, stage III, or metastatic breast cancer.
NCT00429143 A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative Completed Sidney Kimmel Cancer Center at Thomas Jefferson University Phase 1/Phase 2 2006-01-01 The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/or radiation to treat their disease. They will also receive their donor's cells in 2 parts. During the first part, the donor's lymphocytes will be exposed to one of the chemotherapy agents to help the patient become tolerant to the lymphocytes. In the second part of the transplant, the patient will receive their donor's stem cells to help recover their peripheral blood counts and establish long-term engraftment. The hypothesis of this study is that in partially-matched allogeneic transplant, there is a defined number of donor T-cells that can be treated and given to the recipient to avoid post-transplant infection without causing severe graft-versus-host disease.
NCT00651755 Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients Completed Merck Sharp & Dohme Corp. N/A 2008-03-01 The goal of this clinical research study is to learn the effect of combining aprepitant with CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed or has come back. Researchers also want to see if aprepitant can help to prevent nausea and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these patients. CHOP consists of four drugs - Cyclophosphamide (also called Cytoxan/Neosar), Doxorubicin (or Adriamycin), Vincristine (Oncovin) and Prednisolone while R-CHOP includes Rituximab and CHOP.
NCT00651755 Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients Completed M.D. Anderson Cancer Center N/A 2008-03-01 The goal of this clinical research study is to learn the effect of combining aprepitant with CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed or has come back. Researchers also want to see if aprepitant can help to prevent nausea and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these patients. CHOP consists of four drugs - Cyclophosphamide (also called Cytoxan/Neosar), Doxorubicin (or Adriamycin), Vincristine (Oncovin) and Prednisolone while R-CHOP includes Rituximab and CHOP.
NCT00671658 Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia Completed M.D. Anderson Cancer Center Phase 2 2002-11-01 The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Neosar

Condition Name

Condition Name for Neosar
Intervention Trials
Acute Lymphoblastic Leukemia 13
Myelodysplastic Syndrome 8
Recurrent Diffuse Large B-Cell Lymphoma 7
Recurrent Plasma Cell Myeloma 7
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Condition MeSH

Condition MeSH for Neosar
Intervention Trials
Lymphoma 39
Leukemia 36
Leukemia, Lymphoid 31
Precursor Cell Lymphoblastic Leukemia-Lymphoma 29
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Clinical Trial Locations for Neosar

Trials by Country

Trials by Country for Neosar
Location Trials
United States 98
Brazil 5
Canada 3
Czechia 1
Korea, Republic of 1
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Trials by US State

Trials by US State for Neosar
Location Trials
Texas 27
California 20
Washington 12
Pennsylvania 6
New York 5
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Clinical Trial Progress for Neosar

Clinical Trial Phase

Clinical Trial Phase for Neosar
Clinical Trial Phase Trials
Phase 3 7
Phase 2/Phase 3 1
Phase 2 37
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Clinical Trial Status

Clinical Trial Status for Neosar
Clinical Trial Phase Trials
Not yet recruiting 65
Recruiting 23
Completed 5
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Clinical Trial Sponsors for Neosar

Sponsor Name

Sponsor Name for Neosar
Sponsor Trials
National Cancer Institute (NCI) 60
M.D. Anderson Cancer Center 27
City of Hope Medical Center 12
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Sponsor Type

Sponsor Type for Neosar
Sponsor Trials
Other 95
NIH 60
Industry 28
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