Chronic Myeloid Leukemia Clinical Trial
Official title:
An Open-label, Multicenter, Expanded Access Study of Oral AMN107 in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase.
| Verified date | August 2011 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Expanded Access |
This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia who are resistant or intolerant to imatinib and to provide patients access to this new drug until the drug becomes commercially available.
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | November 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - Imatinib-resistant or -intolerant Philadelphia chromosome-positive chronic myeloid leukemia in blast crisis, accelerated phase, or chronic phase. - Chronic myeloid leukemia patients who have been treated with an investigational tyrosine kinase inhibitor. - Laboratory values within normal limits. Exclusion criteria: - Impaired cardiac function. - Acute or chronic liver or renal disease considered unrelated to tumor. - Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol. - Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval or to inhibit the metabolism of AMN107 (CYP3A4/5 inhibitors). - Patients with a history of another malignancy that is currently clinically significant or currently requires active intervention. Other protocol-defined inclusion/exclusion criteria may apply. |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Saint Leonards | |
| Austria | Novartis Investigative Site | Graz | |
| Austria | Novartis Investigative Site | Innsbruck | |
| Austria | Novartis Investigative Site | Linz | |
| Austria | Novartis Investigative Site | Wels | |
| Austria | Novartis Investigative Site | Wien | |
| Belgium | Novartis Investigative Site | Aalst | |
| Belgium | Novartis Investigative Site | Antwerpen | |
| Belgium | Novartis Investigative Site | Arlon | |
| Belgium | Novartis Investigative Site | Brugge | |
| Belgium | Novartis Investigative Site | Brussels | |
| Belgium | Novartis Investigative Site | Bruxelles | |
| Belgium | Novartis Investigative Site | Edegem | |
| Belgium | Novartis Investigative Site | Gent | |
| Belgium | Novartis Investigative Site | Hasselt | |
| Belgium | Novartis Investigative Site | La Louviere | |
| Belgium | Novartis Investigative Site | Leuven | |
| Belgium | Novartis Investigative Site | Liege | |
| Belgium | Novartis Investigative Site | Roeselare | |
| Belgium | Novartis Investigative Site | Verviers | |
| Belgium | Novartis Investigative Site | Yvoir | |
| Brazil | Novartis Investigative Site | Belo Horizonte | |
| Brazil | Novartis Investigative Site | Brasilia-DF | |
| Brazil | Novartis Investigative Site | Campinas | |
| Brazil | Novartis Investigative Site | Curitaba | |
| Brazil | Novartis Investigative Site | Curitiba | |
| Brazil | Novartis Investigative Site | Porto Alegre-RS | |
| Brazil | Novartis Investigative Site | Ribeirao Preto | |
| Brazil | Novartis Investigative Site | Rio de Janeiro | |
| Brazil | Novartis Investigative Site | Sao Paulo | |
| Canada | Novartis Investigative Site | Edmonton | |
| Canada | Novartis Investigative Site | Halifax | |
| Canada | Novartis Investigative Site | Hamilton | |
| Canada | Novartis Investigative Site | Montreal | |
| Canada | Novartis Investigative Site | Ottawa | |
| Canada | Novartis Investigative Site | Toronto | |
| Canada | Novartis Investigative Site | Vancouver | |
| China | Novartis Investigative Site | Beijing | |
| China | Novartis Investigative Site | Guangzhou | |
| China | Novartis Investigative Site | Shanghai | |
| China | Novartis Investigative Site | Tianjing | |
| Czech Republic | Novartis Investigative Site | Brno | |
| Czech Republic | Novartis Investigative Site | Hradec Kralove | |
| Czech Republic | Novartis Investigative Site | Olomouc | |
| Czech Republic | Novartis Investigative Site | Plzen-Lochotin | |
| Czech Republic | Novartis Investigative Site | Praha 2 | |
| Denmark | Novartis Investigative Site | Copenhagen | |
| Denmark | Novartis Investigative Site | Vejle | |
| France | Novartis Investigative Site | Angers | |
| France | Novartis Investigative Site | Bordeaux | |
| France | Novartis Investigative Site | Caen | |
| France | Novartis Investigative Site | Clermont-Ferrand | |
| France | Novartis Investigative Site | Creteil | |
| France | Novartis Investigative Site | Dijon | |
| France | Novartis Investigative Site | Grenoble | |
| France | Novartis Investigative Site | Le Chesnay | |
| France | Novartis Investigative Site | Lille | |
| France | Novartis Investigative Site | Limoges | |
| France | Novartis Investigative Site | Lyon | |
| France | Novartis Investigative Site | Marseille | |
| France | Novartis Investigative Site | Nantes | |
| France | Novartis Investigative Site | Nice | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Poitiers | |
| France | Novartis Investigative Site | Reims | |
| France | Novartis Investigative Site | Rennes | |
| France | Novartis Investigative Site | Rouen | |
| France | Novartis Investigative Site | Strasbourg | |
| France | Novartis Investigative Site | Toulouse | |
| France | Novartis Investigative Site | Vandoeuvre | |
| France | Novartis Investigative Site | Vandoeuvre les Nancy | |
| Germany | Novartis Investigative Site | Aschaffenburg | |
| Germany | Novartis Investigative Site | Augsburg | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Braunschweig | |
| Germany | Novartis Investigative Site | Bremen | |
| Germany | Novartis Investigative Site | Bremerhaven | |
| Germany | Novartis Investigative Site | Chemnitz | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Essen | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Freiburg | |
| Germany | Novartis Investigative Site | Greifswald | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hannover | |
| Germany | Novartis Investigative Site | Heidelberg | |
| Germany | Novartis Investigative Site | Kiel | |
| Germany | Novartis Investigative Site | Koln | |
| Germany | Novartis Investigative Site | Leipzig | |
| Germany | Novartis Investigative Site | Mainz | |
| Germany | Novartis Investigative Site | Mannheim | |
| Germany | Novartis Investigative Site | Marburg | |
| Germany | Novartis Investigative Site | Munchen | |
| Germany | Novartis Investigative Site | Oldenburg | |
| Germany | Novartis Investigative Site | Osnabruck | |
| Germany | Novartis Investigative Site | Regensburg | |
| Germany | Novartis Investigative Site | Stuttgart | |
| Germany | Novartis Investigative Site | Tubingen | |
| Germany | Novartis Investigative Site | Ulm | |
| Germany | Novartis Investigative Site | Weiden | |
| Germany | Novartis Investigative Site | Wiesbaden | |
| Greece | Novartis Investigative Site | Athens | |
| Hong Kong | Novartis Investigative Site | Pokfulam | |
| Hungary | Novartis Investigative Site | Budapest | |
| Ireland | Novartis Investigative Site | Dublin | |
| Italy | Novartis Investigative Site | Ancona | |
| Italy | Novartis Investigative Site | Bari | |
| Italy | Novartis Investigative Site | Bologna | |
| Italy | Novartis Investigative Site | Bolzano | |
| Italy | Novartis Investigative Site | Brescia | |
| Italy | Novartis Investigative Site | Cagliari | |
| Italy | Novartis Investigative Site | Campobasso | |
| Italy | Novartis Investigative Site | Catania | |
| Italy | Novartis Investigative Site | Catanzaro | |
| Italy | Novartis Investigative Site | Ferrara | |
| Italy | Novartis Investigative Site | Firenze | |
| Italy | Novartis Investigative Site | Genova | |
| Italy | Novartis Investigative Site | Milano | |
| Italy | Novartis Investigative Site | Monza | |
| Italy | Novartis Investigative Site | Napoli | |
| Italy | Novartis Investigative Site | Novara | |
| Italy | Novartis Investigative Site | Nuoro | |
| Italy | Novartis Investigative Site | Orbassano | |
| Italy | Novartis Investigative Site | Padova | |
| Italy | Novartis Investigative Site | Palermo | |
| Italy | Novartis Investigative Site | Pavia | |
| Italy | Novartis Investigative Site | Perugia | |
| Italy | Novartis Investigative Site | Pesaro | |
| Italy | Novartis Investigative Site | Pescara | |
| Italy | Novartis Investigative Site | Pisa | |
| Italy | Novartis Investigative Site | Reggio Calabria | |
| Italy | Novartis Investigative Site | Reggio Emilia | |
| Italy | Novartis Investigative Site | Rionero in Vulture | |
| Italy | Novartis Investigative Site | Roma | |
| Italy | Novartis Investigative Site | Ronciglione | |
| Italy | Novartis Investigative Site | San Giovanni Rotundo | |
| Italy | Novartis Investigative Site | Siena | |
| Italy | Novartis Investigative Site | Tarante | |
| Italy | Novartis Investigative Site | Torino | |
| Italy | Novartis Investigative Site | Udine | |
| Italy | Novartis Investigative Site | Via Pansini | |
| Korea, Republic of | Novartis Investigative Site | Daegu | |
| Korea, Republic of | Novartis Investigative Site | Deajeon | |
| Korea, Republic of | Novartis Investigative Site | Jeollanam-do | |
| Korea, Republic of | Novartis Investigative Site | Pusan | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Lebanon | Novartis Investigative Site | Beirut | |
| Malaysia | Novartis Investigative Site | Georgetown, Penang | |
| Malaysia | Novartis Investigative Site | Kuala Lumpur | |
| Malaysia | Novartis Investigative Site | Pulau Pinang | |
| Malaysia | Novartis Investigative Site | Subang Jaya, Selangor | |
| Mexico | Novartis Investigative Site | Mexico D.F. | |
| Netherlands | Novartis Investigative Site | Amsterdam | |
| Netherlands | Novartis Investigative Site | Enschede | |
| Netherlands | Novartis Investigative Site | Leiden | |
| Netherlands | Novartis Investigative Site | Maastricht | |
| Netherlands | Novartis Investigative Site | Rotterdam | |
| Norway | Novartis Investigative Site | Oslo | |
| Poland | Novartis Investigative Site | Gdansk | |
| Poland | Novartis Investigative Site | Krakow | |
| Poland | Novartis Investigative Site | Poznan | |
| Poland | Novartis Investigative Site | Szczecin | |
| Poland | Novartis Investigative Site | Warszawa | |
| Russian Federation | Novartis Investigative Site | Chelyabinsk | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Novosibirsk | |
| Russian Federation | Novartis Investigative Site | Saint-Petersburg | |
| Russian Federation | Novartis Investigative Site | Samara | |
| Russian Federation | Novartis Investigative Site | Ufa | |
| Singapore | Novartis Investigative Site | Singapore | |
| Slovakia | Novartis Investigative Site | Bratislava | |
| Slovakia | Novartis Investigative Site | Kosice | |
| South Africa | Novartis Investigative Site | Cape Town | |
| South Africa | Novartis Investigative Site | Johannesburg | |
| South Africa | Novartis Investigative Site | Roodepoort, Gauteng | |
| Spain | Novartis Investigative Site | Baracaldo, Pais Vasco | |
| Spain | Novartis Investigative Site | Barcelona, Cataluna | |
| Spain | Novartis Investigative Site | Cataluna | |
| Spain | Novartis Investigative Site | Granada, Andalucia | |
| Spain | Novartis Investigative Site | Las Palmas de Gran Canaria | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | |
| Spain | Novartis Investigative Site | Murcia | |
| Spain | Novartis Investigative Site | Salamanca, Castilla y Leon | |
| Spain | Novartis Investigative Site | San Sabastian, Pais Vasco | |
| Spain | Novartis Investigative Site | Santiago de Compostela | |
| Spain | Novartis Investigative Site | Valencia | |
| Spain | Novartis Investigative Site | Zaragoza | |
| Sweden | Novartis Investigative Site | Goteborg | |
| Sweden | Novartis Investigative Site | Linkoping | |
| Sweden | Novartis Investigative Site | Lund | |
| Sweden | Novartis Investigative Site | Stockholm | |
| Sweden | Novartis Investigative Site | Uppsala | |
| Switzerland | Novartis Investigative Site | Basel | |
| Switzerland | Novartis Investigative Site | Bern | |
| Switzerland | Novartis Investigative Site | Lausanne | |
| Switzerland | Novartis Investigative Site | Zurich | |
| Taiwan | Novartis Investigative Site | Chiayi | |
| Taiwan | Novartis Investigative Site | Kaohsiung | |
| Taiwan | Novartis Investigative Site | Taichung | |
| Taiwan | Novartis Investigative Site | Tainan | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Thailand | Novartis Investigative Site | Bangkok | |
| Turkey | Novartis Investigative Site | Ankara | |
| Turkey | Novartis Investigative Site | Istanbul | |
| Turkey | Novartis Investigative Site | Malatya | |
| Turkey | Novartis Investigative Site | Samsun | |
| United Kingdom | Novartis Investigative Site | Cambridge | |
| United Kingdom | Novartis Investigative Site | Leeds | |
| United Kingdom | Novartis Investigative Site | Liverpool | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | Manchester | |
| United Kingdom | Novartis Investigative Site | Nottingham | |
| United States | University of New Mexico Health Sciences Center | Albuquerque | New Mexico |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Emory University Cancer Institute | Atlanta | Georgia |
| United States | Medical College of Georgia | Augusta | Georgia |
| United States | University of Colorado | Aurora | Colorado |
| United States | St. Agnes Hospital | Baltimore | Maryland |
| United States | St. Francis Hospital & Health Centers | Beech Grove | Indiana |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Charleston Hematology Oncology | Charleston | South Carolina |
| United States | MUSC Hollings Cancer Center | Charleston | South Carolina |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Stroger Cook County Hospital | Chicago | Illinois |
| United States | University of Chicago Hospital | Chicago | Illinois |
| United States | University of Illinois at Chicago | Chicago | Illinois |
| United States | Three Medical Park | Columbia | South Carolina |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Rocky Mountain Cancer Center | Denver | Colorado |
| United States | Wayne State University | Detroit | Michigan |
| United States | City of Hope National Medical Center | Duarte | California |
| United States | Duke University | Durham | North Carolina |
| United States | The Jones Clinic | Germantown | Tennessee |
| United States | Cancer Center of the Carolinas | Greenville | South Carolina |
| United States | St. John Hospital and Medical Center | Grosse Pointe | Michigan |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
| United States | Antelope Valley Cancer Center | Lancaster | California |
| United States | Nevada Cancer Institute | Las Vegas | Nevada |
| United States | Southeast Nebraska Cancer Center | Lincoln | Nebraska |
| United States | Louisville Oncology Research | Louisville | Kentucky |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | Osler Medical Inc./Osler Clinical Research | Melbourne | Florida |
| United States | Advanced Medical Specialties | Miami | Florida |
| United States | Winthrop Hematology/Oncology | Mineola | New York |
| United States | University of South Alabama Cancer Research Institute | Mobile | Alabama |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | Weill Cornell Medical Center | New York | New York |
| United States | Cancer Care Associates | Oklahoma City | Oklahoma |
| United States | Nebraska Methodist Cancer Center | Omaha | Nebraska |
| United States | Integrated Community | Orange Park | Florida |
| United States | Florida Hospital Cancer Institute | Orlando | Florida |
| United States | MD Anderson Cancer Center | Orlando | Florida |
| United States | Stanford University | Palo Alto | California |
| United States | Hematology Oncology Assoc. | Pensacola | Florida |
| United States | Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania |
| United States | Oregon Health Sciences University | Portland | Oregon |
| United States | Mayo Clinic Hospital | Rochester | Minnesota |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | Utah Cancer Specialists | Salt Lake City | Utah |
| United States | Cancer Institute of New Mexico | Santa Fe | New Mexico |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | LSU Health Sciences Center | Shreveport | Louisiana |
| United States | Arizona Cancer Center | Tucson | Arizona |
| United States | Cancer Care Associates | Tulsa | Oklahoma |
| United States | Georgetown University Medical Center-Lombardi Cancer Center | Washington | District of Columbia |
| United States | Washington Cancer Institute | Washington | District of Columbia |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| United States | Wake Forest University | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Korea, Republic of, Lebanon, Malaysia, Mexico, Netherlands, Norway, Poland, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom,
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
| Completed |
NCT02057185 -
Occupational Status and Hematological Disease
|
||
| Recruiting |
NCT03326310 -
Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
|
Phase 1 | |
| Recruiting |
NCT04621851 -
Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
|
||
| Completed |
NCT01207440 -
Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)
|
Phase 2 | |
| Not yet recruiting |
NCT06409936 -
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
|
Phase 2 | |
| Active, not recruiting |
NCT02917720 -
2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients
|
Phase 2 | |
| Not yet recruiting |
NCT02883036 -
Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia
|
N/A | |
| Withdrawn |
NCT01188889 -
RAD001 in Patients With Chronic Phase Chronic Myeloid Leukemia w/ Molecular Disease.
|
Phase 1/Phase 2 | |
| Completed |
NCT01795716 -
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
|
Phase 1 | |
| Completed |
NCT00988013 -
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
|
N/A | |
| Approved for marketing |
NCT00905593 -
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
|
Phase 3 | |
| Terminated |
NCT00573378 -
Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia
|
Phase 2 | |
| Terminated |
NCT00522990 -
Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
|
Phase 1/Phase 2 | |
| Completed |
NCT00469014 -
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
|
Phase 2 | |
| Unknown status |
NCT00598624 -
Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
|
Phase 2 | |
| Completed |
NCT00257647 -
Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML)
|
N/A | |
| Completed |
NCT00219739 -
STI571 ProspectIve RandomIzed Trial: SPIRIT
|
Phase 3 | |
| Completed |
NCT06148493 -
Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
|
||
| Completed |
NCT00375219 -
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
|
Phase 2 |