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Expanded Access Program of Ponatinib (AP24534) for Patients With Refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Colección de datos

Quiénes son elegibles

Enfermedades de la Médula Ósea+9

+ Enfermedades hemáticas y linfáticas

+ Enfermedad Crónica

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo se puede acceder

Completado

Disponible bajo solicitud por un médico con licencia
Acceso Ampliado
Ver detalles del protocolo

Resumen

Patrocinador PrincipalAriad Pharmaceuticals
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

This protocol will allow expanded access of ponatinib to patients ≥18 years with CML or Ph+ALL who have failed all available treatment options. Patients with chronic (CP) or accelerated phase (AP) CML must be previously treated with and resistant or intolerant to imatinib, dasatinib and nilotinib or develop the T315I mutation after any tyrosine kinase inhibitor (TKI) therapy. Patients with blast phase (BP) CML and Ph+ ALL must be previously treated with and resistant or intolerant to imatinib and dasatinib or develop the T315I mutation after any TKI therapy. No formal analysis will be performed on any data obtained. Safety information will be collected and adverse events will be tabulated for reporting purposes only.

Título OficialExpanded Access Program of Ponatinib (AP24534) for Patients With Refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia
NCT01592136
Patrocinador PrincipalAriad Pharmaceuticals
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Condiciones

Patología

Enfermedades de la Médula ÓseaEnfermedades hemáticas y linfáticasEnfermedad CrónicaEnfermedades HematológicasLeucemia MieloideLeucemiaTrastornos MieloproliferativosNeoplasiasNeoplasias por tipo histológicoProcesos PatológicosCondiciones Patológicas, Signos y SíntomasLeucemia Mieloide Crónica BCR-ABL Positiva

Criterios

Main Inclusion Criteria: 1. CP-CML and AP-CML patients previously treated with and resistant or intolerant to imatinib, dasatinib and nilotinib or those who developed the T315I mutation after any TKI therapy. BP-CML and Ph+ ALL patients previously treated with and resistant or intolerant to imatinib and dasatinib or those who developed the T315I mutation after any TKI therapy. 2. Patients must be ≥ 18 years old. 3. Provide written informed consent. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 5. Men and women of childbearing potential must agree to effective contraception from the time of signing informed consent through the Follow-up Visit, approximately 30 days after last dose of ponatinib. Main Exclusion Criteria: Patients are not eligible for participation in the study if they meet any of the following exclusion criteria: 1. Are eligible for an ongoing and accessible clinical trial of ponatinib 2. Have not adequately recovered from AEs due to agents previously administered 3. Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy. 4. Have previously been treated with ponatinib. 5. Have significant or active cardiovascular disease, specifically including, but not restricted to: * Myocardial infarction within 3 months prior to first dose of ponatinib, * History of clinically significant atrial arrhythmia or any ventricular arrhythmia, * Unstable angina within 3 months prior to first dose of ponatinib, * Congestive heart failure within 3 months prior to first dose of ponatinib. 6. Have abnormal QTcF (\> 450 ms for males or \> 470 ms for females) 7. Have a significant bleeding disorder unrelated to CML or Ph+ ALL. 8. Have a history of pancreatitis or alcohol abuse 9. Have elevated amylase or lipase (\> 1.5 x ULN for institution) at entry. 10. Have inadequate hepatic function or any of the following: * Total bilirubin \> 1.5 x ULN for institution at entry * Alanine aminotransferase and aspartate aminotransferase \> 2.5 x ULN for institution at entry * Prothrombin time \>1.5 x ULN for institution at entry 11. Have inadequate renal function or serum creatinine \> 2.5 x ULN for institution at entry 12. Have uncontrolled hypertriglyceridemia or triglycerides \> 450 mg/dL at entry. 13. Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of orally administered ponatinib. 14. Women who are pregnant or lactating. 15. Underwent major surgery within 14 days prior to the first dose of ponatinib. 16. Have ongoing or active infection (including known history of human immunodeficiency virus \[HIV\], hepatitis B virus \[HBV\], or hepatitis C virus \[HCV\]). 17. Suffer from any condition or illness that, in the opinion of the Investigator would compromise patient safety or interfere with the evaluation of the safety of the study drug.

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 33 ubicaciones

Suspendido

Moores UCSD Cancer Center, Site #165

La Jolla, United StatesAbrir Moores UCSD Cancer Center, Site #165 en Google Maps
Suspendido

Southern California Permanente Medical Group, Site #161

San Marcos, United States
Suspendido

Kaiser Permanente Medical Center, Site #158

Vallejo, United States
Suspendido

Smilow Cancer Hospital at Yale New Haven, Site #182

New Haven, United States
Completado33 Centros de Estudio