A Phase I Study of Ribociclib plus Everolimus and Dexamethasone in Children and Young Adults with Relapsed Acute Lymphoblastic Leukemia

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Full Title

Phase I trial of Ribociclib in Combination with Everolimus and Dexamethasone in Children and Young Adults with Relapsed Acute Lymphoblastic Leukemia

Purpose

The purpose of this study is to find the best doses of the anticancer drugs ribociclib and everolimus to use in combination with dexamethasone in children and young adults with acute lymphoblastic leukemia (ALL) that has come back despite prior therapy. Ribociclib is a chemotherapy drug used to treat certain types of breast cancer. It works by blocking the activity of proteins in cancer cells called CDKs which drive cancer growth. Some studies suggest that ribociclib may be effective for treating people with relapsed ALL.

Everolimus is used to treat several types of cancer, including kidney and breast cancer. It works by blocking a cell signaling pathway called mTOR that cancer cells use to grow and survive. The use of these two drugs in this study is considered investigational. Ribociclib, everolimus, and dexamethasone are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is for patients older than one year of age and no older than 30.
  • Patients must have ALL that came back or continued to grow despite treatment.
  • Patients should recover from the serious side effects of prior treatments before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please contact Dr. Maria Luisa Sulis at 212-639-5175.

Protocol

19-482

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators