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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR NILOTINIB HYDROCHLORIDE

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Clinical Trials for Nilotinib Hydrochloride

Trial ID Title Status Sponsor Phase 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, Da Active, not recruiting National Cancer Institute (NCI) Phase 2 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, Da Active, not recruiting Fred Hutchinson Cancer Research Center Phase 2 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 Blood Related Cancers Completed Novartis Pharmaceuticals Phase 1/Phase 2 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) Active, not recruiting Novartis Phase 2 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) Active, not recruiting M.D. Anderson Cancer Center Phase 2 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.
NCT00384228 A Phase l/ll Study of AMN107 in Adult Patients With Glivec-intolerant CML or Relapsed-refractory Ph+ALL Completed Novartis Pharmaceuticals Phase 1/Phase 2 This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.
NCT00413270 Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant No longer available Novartis Pharmaceuticals Phase 3 This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Nilotinib Hydrochloride

Condition Name

Condition Name for Nilotinib Hydrochloride
Intervention Trials
Chronic Myeloid Leukemia 33
Chronic Myelogenous Leukemia 16
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 99
Leukemia 95
Leukemia, Myeloid 89
Philadelphia Chromosome 25
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Clinical Trial Locations for Nilotinib Hydrochloride

Trials by Country

Trials by Country for Nilotinib Hydrochloride
Location Trials
United States 318
Italy 179
Spain 90
Japan 89
Brazil 57
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Trials by US State

Trials by US State for Nilotinib Hydrochloride
Location Trials
Texas 28
California 22
Florida 17
New York 17
Massachusetts 15
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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 18
Phase 3 28
Phase 2 65
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Clinical Trial Status

Clinical Trial Status for Nilotinib Hydrochloride
Clinical Trial Phase Trials
Completed 52
Recruiting 38
Active, not recruiting 30
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Clinical Trial Sponsors for Nilotinib Hydrochloride

Sponsor Name

Sponsor Name for Nilotinib Hydrochloride
Sponsor Trials
Novartis Pharmaceuticals 65
Novartis 19
M.D. Anderson Cancer Center 8
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Sponsor Type

Sponsor Type for Nilotinib Hydrochloride
Sponsor Trials
Other 124
Industry 107
NIH 7
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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Deloitte
Farmers Insurance
McKesson
Covington
Fuji
Dow
Julphar

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