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Last Updated: November 4, 2024

CLINICAL TRIALS PROFILE FOR TRISENOX


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505(b)(2) Clinical Trials for TRISENOX

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 NCT00225992 ↗ Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS) Terminated Oncology Specialties, Alabama Phase 2 2004-02-01 In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule. Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for TRISENOX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003934 ↗ Tretinoin, Cytarabine, and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia Completed National Cancer Institute (NCI) Phase 3 1999-06-01 This randomized phase III trial is studying tretinoin and combination chemotherapy to see how well they work compared to tretinoin, combination chemotherapy, and arsenic trioxide in treating patients with acute promyelocytic leukemia that has not been treated previously. Drugs used in chemotherapy, such as daunorubicin, cytarabine, mercaptopurine, methotrexate, and arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Tretinoin may help leukemia cells develop into normal white blood cells. It is not yet known which regimen is more effective for acute promyelocytic leukemia.
NCT00005786 ↗ Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia Terminated National Cancer Institute (NCI) N/A 2001-01-01 Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory lymphoma or leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
NCT00006092 ↗ Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia Terminated National Cancer Institute (NCI) Phase 2 2000-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.
NCT00006092 ↗ Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia Terminated H. Lee Moffitt Cancer Center and Research Institute Phase 2 2000-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TRISENOX

Condition Name

Condition Name for TRISENOX
Intervention Trials
Leukemia 4
Multiple Myeloma 3
Acute Promyelocytic Leukemia With PML-RARA 2
Untreated Adult Acute Myeloid Leukemia 2
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Condition MeSH

Condition MeSH for TRISENOX
Intervention Trials
Leukemia 14
Leukemia, Promyelocytic, Acute 7
Leukemia, Myeloid 5
Neoplasms, Plasma Cell 5
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Clinical Trial Locations for TRISENOX

Trials by Country

Trials by Country for TRISENOX
Location Trials
United States 124
Canada 11
Australia 5
Puerto Rico 2
New Zealand 2
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Trials by US State

Trials by US State for TRISENOX
Location Trials
Texas 10
California 9
New York 7
Illinois 6
Ohio 5
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Clinical Trial Progress for TRISENOX

Clinical Trial Phase

Clinical Trial Phase for TRISENOX
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2 19
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Clinical Trial Status

Clinical Trial Status for TRISENOX
Clinical Trial Phase Trials
Completed 18
Terminated 11
Withdrawn 3
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Clinical Trial Sponsors for TRISENOX

Sponsor Name

Sponsor Name for TRISENOX
Sponsor Trials
National Cancer Institute (NCI) 16
Cephalon 7
The University of Texas Medical Branch, Galveston 3
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Sponsor Type

Sponsor Type for TRISENOX
Sponsor Trials
Other 37
NIH 17
Industry 14
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