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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR NILOTINIB HYDROCHLORIDE


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All Clinical Trials for Nilotinib Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00036738 ↗ Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D Completed National Cancer Institute (NCI) Phase 2 2001-07-13 This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00036738 ↗ Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D Completed Fred Hutchinson Cancer Research Center Phase 2 2001-07-13 This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00109707 ↗ A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies Completed Novartis Pharmaceuticals Phase 1/Phase 2 2005-04-01 The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions: Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1) Group A - Imatinib failure only (arms 2, 3 and 4) - imatinib-resistant or intolerant CML - Chronic Phase (CP) - imatinib-resistant or intolerant CML - Accelerated Phase (AP) - imatinib-resistant or intolerant CML - Blast Crisis (BC) Group B - Imatinib and other TKI failure (arms 2, 3 and 4) - imatinib-resistant or intolerant CML - Chronic Phase (CP) - imatinib-resistant or intolerant CML - Accelerated Phase (AP) - imatinib-resistant or intolerant CML - Blast Crisis (BC) Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5) Systemic mastocytosis (Sm) (arm 6)
NCT00129740 ↗ Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) Completed Novartis Phase 2 2005-06-27 The goal of this clinical research study is to learn if an experimental agent, AMN107 (nilotinib), can help to control CML in chronic phase. The safety of this experimental agent will also be studied.
NCT00129740 ↗ Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) Completed M.D. Anderson Cancer Center Phase 2 2005-06-27 The goal of this clinical research study is to learn if an experimental agent, AMN107 (nilotinib), can help to control CML in chronic phase. The safety of this experimental agent will also be studied.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nilotinib Hydrochloride

Condition Name

Condition Name for Nilotinib Hydrochloride
Intervention Trials
Chronic Myeloid Leukemia 40
CHRONIC MYELOGENOUS LEUKEMIA 17
Leukemia 11
Gastrointestinal Stromal Tumors 10
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Condition MeSH

Condition MeSH for Nilotinib Hydrochloride
Intervention Trials
Leukemia, Myelogenous, Chronic, BCR-ABL Positive 115
Leukemia 113
Leukemia, Myeloid 105
Philadelphia Chromosome 32
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Clinical Trial Locations for Nilotinib Hydrochloride

Trials by Country

Trials by Country for Nilotinib Hydrochloride
Location Trials
United States 434
Italy 219
Japan 104
Spain 102
France 67
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Trials by US State

Trials by US State for Nilotinib Hydrochloride
Location Trials
Texas 34
California 25
New York 22
Florida 20
Maryland 19
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Clinical Trial Progress for Nilotinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Nilotinib Hydrochloride
Clinical Trial Phase Trials
Phase 4 17
Phase 3 32
Phase 2 83
[disabled in preview] 47
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Clinical Trial Status

Clinical Trial Status for Nilotinib Hydrochloride
Clinical Trial Phase Trials
Completed 89
Recruiting 31
Terminated 24
[disabled in preview] 35
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Clinical Trial Sponsors for Nilotinib Hydrochloride

Sponsor Name

Sponsor Name for Nilotinib Hydrochloride
Sponsor Trials
Novartis Pharmaceuticals 69
Novartis 20
National Cancer Institute (NCI) 14
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Sponsor Type

Sponsor Type for Nilotinib Hydrochloride
Sponsor Trials
Other 170
Industry 129
NIH 15
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