A Phase 1 Study of Selinexor and Venetoclax with Chemotherapy in Children, Teens, and Young Adults with Acute Leukemia

Full Title

SELCLAX: A Phase I and Expansion Cohort Study of Selinexor and Venetoclax in Combination with Chemotherapy in Pediatric and Young Adult Patients with Refractory or Relapsed Acute Myeloid Leukemia

Purpose

Past studies have shown that giving venetoclax or selinexor with different types of chemotherapy can work well against leukemia. However, this treatment does not work for many people with leukemia. Researchers think that combining both venetoclax and selinexor with chemotherapy may work better.

In this study, researchers will find the best doses of venetoclax and selinexor to give with chemotherapy. The people in this study have acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL). They have cancer that came back or keeps growing even after treatment.

Venetoclax blocks a protein called Bcl-2 in cancer cells that helps them survive and resist the effects of cancer treatments. Selinexor works by trapping proteins inside cancer cells that block tumor growth. Selinexor also makes it easier for the immune system to work against cancer cells and stop their resistance to venetoclax.

Who Can Join

To join this study, there are a few conditions. You or your child must:

• Have AML or ALAL that came back or keeps growing after treatment.
• Have good organ function.
• Not be receiving chemotherapy when you enter the study.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 2-30.

 

Contact

For more information and to see if you or your child can join this study, please call 833-MSK-KIDS.