MM1YA-A04: Adding Venetoclax or GO to 7+3 in AML - Clinical Trial

¿Cuál es el Propósito de este estudio?

In this study, people will be placed into treatment groups by a computer. They will be assigned by chance to receive either the usual treatment or a treatment that includes a study medicine called venetoclax. The usual treatment includes cancer medicines called gemtuzumab ozogamicin, cytarabine, and daunorubicin. The study treatment includes venetoclax along with cytarabine and daunorubicin.

Researchers want to compare these treatment options to see which works better and how safe they are for people with this type of leukemia.

¿Cuál es la Condición que se está estudiando?

This study is for people who have a type of blood cancer called acute myeloid leukemia. Their cancer has specific changes in genes called RUNX1 RUNX1T1 or CBFB MYH11. These gene changes are part of a group called core binding factor acute myeloid leukemia. Researchers want to learn more about this type of leukemia and improve treatment for people who have it.

¿Quién puede participar en el Estudio?

People can join this study if they are between 18 and 59 years old and have a type of blood cancer called acute myeloid leukemia with certain genetic changes. They cannot have received previous treatment for acute myeloid leukemia or a related blood condition called myelodysplastic syndrome. Participants must be healthy enough to do most daily activities, even if they need some help. They cannot be pregnant or breastfeeding. Doctors will also review other health conditions to make sure the study is safe for them.

Grupo etario
Adultos

¿Qué Implica?

This study is being done to find out if a new treatment plan works better than the usual treatment for a type of blood cancer called core binding factor acute myeloid leukemia. Researchers will compare the usual treatment to a treatment that includes a medicine called venetoclax.

The goal is to see which treatment helps more people reach a complete remission, meaning no signs of active leukemia can be found, and whether very small amounts of leukemia are also gone after the first phase of treatment. This information may help doctors choose the best treatment for people with this type of leukemia in the future.

Detalles del Estudio

Título Completo
MM1YA-A04: Phase II Study of Cytarabine + Daunorubicin (7+3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7+3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy ( NCT:06917911)
Investigador Principal
Harry P. Erba, MD, PhD
Especialista en oncología hematológica
Número de Protocolo
IRB: PRO00120488
NCT: NCT06917911
Fase
Phase II
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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Contribuya a Duke Health