A Phase 1/2 Study of Venetoclax and Navitoclax in Children, Adolescents, and Young Adults With Leukemia

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Full Title

RAVEN: A Phase I/II Trial treating Relapsed Acute Lymphoblastic Leukemia with Venetoclax and Navitoclax

Purpose

Researchers want to see if adding venetoclax and navitoclax to chemotherapy works well against leukemia in young people. The people in this study are children, adolescents, and young adults with acute lymphoblastic leukemia (ALL). The ALL has come back or keeps growing even with treatment.

Venetoclax and navitoclax block proteins in cancer cells called BCL-2 and BCL-xL, which help cancer cells survive. These two drugs may make cancer cells more sensitive to chemotherapy.

People in this study will first get venetoclax and navitoclax with standard chemotherapy. The chemotherapy drugs include dexamethasone, vincristine, calaspargase, dasatinib, blinatumomab, and mercaptopurine. The chemotherapy drugs you get or your child gets will depend on the specific features of your type of leukemia.

Next, you or your child will get different combinations of medications depending on whether the leukemia cells have a protein called CD19. After this part of the study, some participants will receive different combinations of medications, depending on their response to the first treatments.

Who Can Join

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

  • Have ALL that came back or keeps getting worse even after treatment.
  • Have recovered from the serious side effects of prior therapies before getting the study treatment.
  • Be age 4-29.

Contact

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

Protocol

24-023

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05192889