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Approved For Marketing No phase listed Expanded access

Expanded Access Program of Ponatinib

NCT01592136
Conditions
Chronic Myeloid Leukemia (CML), Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Interventions
ponatinib
Drug
Lead sponsor
Ariad Pharmaceuticals
Industry
Eligibility
18 Years and older
U.S. locations
33
States / cities
La Jolla, California • San Marcos, California • Vallejo, California + 28 more
Conditions
Myeloid Leukemia, Chronic, Accelerated Phase, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Interventions
dasatinib
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years and older
Enrollment
638 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2013
U.S. locations
26
States / cities
Birmingham, Alabama • Loma Linda, California • Los Angeles, California + 21 more
Conditions
B-cell Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia (CML) in Lymphoid Blast Crisis, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL
Interventions
ABL001, Dasatinib, Prednisone, Blinatumomab
Drug
Lead sponsor
Marlise Luskin, MD
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2027
U.S. locations
4
States / cities
Chicago, Illinois • Boston, Massachusetts • Buffalo, New York
Conditions
Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
Interventions
Bosutinib, Imatinib
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
536 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2020
U.S. locations
65
States / cities
Anaheim, California • Atlanta, Georgia • Honolulu, Hawaii + 40 more
Conditions
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Interventions
Cyclophosphamide, Psoralen, Thiotepa, Allogeneic bone marrow transplantation, In vitro-treated peripheral blood stem cell transplantation (PBSCT), Radiation Therapy (RT)
Drug · Procedure · Radiation
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
Up to 49 Years
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2002
U.S. locations
3
States / cities
Chicago, Illinois • St Louis, Missouri • Houston, Texas
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Myeloid Leukemia in Remission, Adult Erythroleukemia (M6a), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Adult Pure Erythroid Leukemia (M6b), Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Erythroleukemia (M6), Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Myeloid Leukemia in Remission, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Cutaneous B-cell Non-Hodgkin Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Philadelphia Chromosome Negative Chronic Myelogenous Leukemia, Post-transplant Lymphoproliferative Disorder, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage III Multiple Myeloma, Testicular Lymphoma, Waldenström Macroglobulinemia
Interventions
cyclophosphamide, cyclosporine, peripheral blood stem cell transplantation, total-body irradiation, fludarabine phosphate, busulfan, allogeneic hematopoietic stem cell transplantation
Drug · Procedure · Radiation
Lead sponsor
Fred Hutchinson Cancer Center
Other
Eligibility
Up to 65 Years
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
1
States / cities
Seattle, Washington
Conditions
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Interventions
anti-thymocyte globulin, cyclophosphamide, cyclosporine, fludarabine phosphate, methylprednisolone, UV light therapy, allogeneic bone marrow transplantation, peripheral blood stem cell transplantation
Biological · Drug · Procedure
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
18 Years to 120 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2003
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia, Adult Acute Lymphoblastic Leukemia in Complete Remission, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive, Untreated Adult Acute Lymphoblastic Leukemia
Interventions
Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Methotrexate, Ponatinib, Ponatinib Hydrochloride, Prednisone, Rituximab, Vincristine, Vincristine Sulfate
Drug · Other · Biological
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2027
U.S. locations
1
States / cities
Houston, Texas
Conditions
Leukemia
Interventions
filgrastim, cytarabine, etoposide, hydroxyurea, mitoxantrone hydrochloride, peripheral blood stem cell transplantation
Biological · Drug · Procedure
Lead sponsor
Fred Hutchinson Cancer Center
Other
Eligibility
17 Years to 65 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1994 – 2000
U.S. locations
1
States / cities
Seattle, Washington
Conditions
Leukemia
Interventions
Azacitidine (AZA), Tyrosine kinase inhibitor (TKI), Azacitidine
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
16 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2019
U.S. locations
1
States / cities
Houston, Texas
Conditions
Leukemia
Interventions
Dasatinib, Imatinib
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
45
States / cities
Huntsville, Alabama • Little Rock, Arkansas • Alhambra, California + 39 more
Conditions
CML, Chronic Phase, CML (Chronic Myelogenous Leukemia, CML - Philadelphia Chromosome, Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic Phase
Interventions
Bosutinib, Dasatinib, Imatinib, Nilotinib
Drug
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Conditions
Myeloid Leukemia, Chronic, Chronic-Phase
Interventions
dasatinib
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 90 Years
Enrollment
724 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2014
U.S. locations
40
States / cities
Birmingham, Alabama • Alhambra, California • Anaheim, California + 33 more
Conditions
Leukemia
Interventions
imatinib mesylate
Drug
Lead sponsor
Novartis
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2000
U.S. locations
1
States / cities
East Hanover, New Jersey
Conditions
Leukemia
Interventions
Arsenic Trioxide
Drug
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2000 – 2003
U.S. locations
1
States / cities
Tampa, Florida
Conditions
Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST), Acute Lymphoblastic Leukemia (ALL), Receptor Tyrosine Kinase (KIT) Mutated Melanoma
Interventions
Nilotinib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
Not listed
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2023
U.S. locations
2
States / cities
Albany, New York • Houston, Texas
Conditions
Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
Interventions
Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
405 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2031
U.S. locations
13
States / cities
Denver, Colorado • Fort Myers, Florida • Tallahassee, Florida + 9 more
Conditions
Chronic Myelogenous Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Interventions
Asciminib (ABL001), Nilotinib, Imatinib, Dasatinib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
326 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2023
U.S. locations
6
States / cities
Boston, Massachusetts • Ann Arbor, Michigan • New York, New York + 3 more
Conditions
Leukemia
Interventions
imatinib mesylate
Drug
Lead sponsor
Novartis
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2000 – 2002
U.S. locations
1
States / cities
East Hanover, New Jersey
Conditions
Leukemia
Interventions
recombinant interferon alfa, sargramostim
Biological
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1998 – 2010
U.S. locations
1
States / cities
Baltimore, Maryland
Conditions
Previously Treated PH + CML
Interventions
Bosutinib
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
163 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2020
U.S. locations
13
States / cities
Los Angeles, California • Deerfield Beach, Florida • Miami, Florida + 6 more
Conditions
Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive
Interventions
Asciminib single agent
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
1 Year to 18 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
4
States / cities
New Brunswick, New Jersey • New York, New York • Cincinnati, Ohio + 1 more
Conditions
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Chronic Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Philadelphia Chromosome Negative Chronic Myelogenous Leukemia, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Relapsing Chronic Myelogenous Leukemia
Interventions
decitabine, vorinostat, laboratory biomarker analysis, pharmacological study
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2006
U.S. locations
1
States / cities
Houston, Texas
Conditions
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Interventions
Laboratory Biomarker Analysis, Ponatinib Hydrochloride, Quality-of-Life Assessment
Other · Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2030
U.S. locations
1
States / cities
Houston, Texas