Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
Status:
Recruiting
Trial end date:
2031-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the good and bad effects of the study drugs bortezomib
and vorinostat when they are given in combination with chemotherapy commonly used to treat
acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease
the number of leukemia cells, but it could also cause additional side effects. Bortezomib and
vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other
cancers in adults, but they have not been approved for treating children with leukemia. With
this research, we plan to meet the following goals:
PRIMARY OBJECTIVE:
- Determine the tolerability of incorporating bortezomib and vorinostat into an ALL
chemotherapy backbone for newly diagnosed infants with ALL.
SECONDARY OBJECTIVES:
- Estimate the event-free survival and overall survival of infants with ALL who are
treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone.
- Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.
- Compare end of induction, end of consolidation, and end of reinduction MRD levels to
Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant
outcomes.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborators:
Baylor College of Medicine Gateway for Cancer Research Texas Children's Hospital