EA9181 (Acute Lymphoblastic Leukemia) - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to find out if an experimental combination of drugs is an effective treatment for ALL. The combination used in the study is blinatumomab (the study drug) + steroids and tyrosine kinase inhibitors (TKI). We want to know if this drug combination is more effective than the standard treatment of chemotherapy + steroids and TKI.
¿Cuál es la Condición que se está estudiando?
Newly Diagnosed (BCR-ABL-Positive) Acute Lymphoblastic Leukemia
¿Quién puede participar en el Estudio?
Adultos de 18 a 75 años que:
- Are diagnosed with Acute Lymphoblastic Leukemia and have a gene called BCR/ABL
- Have not received chemotherapy treatment for this type of leukemia
- Do not have serious epilepsy that needs to be treated
Para obtener más información sobre quién puede participar en este estudio, comuníquese con el equipo del estudio al 919-684-8964.
Grupo etario
Adultos
¿Qué Implica?
If you choose to join this study, you will get a random assignment to 1 of 2 treatment groups:
- One group will get the standard treatment of chemotherapy + steroids and TKI
- The other will get the study drug + steroids and TKI
Los participantes de ambos grupos:
- Someterse a exámenes físicos
- Tomar muestras de médula ósea
- Have a fluid sample taken from your spinal canal (lumbar puncture)
Detalles del Estudio
Título Completo
EA9181: A Phase III Randomized Trial of Steroids + TKI Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-positive ALL in Adults
Investigador Principal
Especialista en oncología hematológica
Número de Protocolo
IRB:
PRO00108100
NCT:
NCT04530565
Fase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
Participate
Call 919-681-4769