Clinical Trial: NCT02553460
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | St. Jude Children's Research Hospital |
| Information Provided By: | St. Jude Children's Research Hospital |
| Last Update Posted: | 2026-06-24 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: ITMHA
- Drug: Dexamethasone
- Drug: Mitoxantrone
- Drug: Pegaspargase
- Drug: Asparaginase Erwinia Chrysanthemi
- Drug: Bortezomib
- Drug: Vorinostat
- Drug: Cyclophosphamide
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Leucovorin Calcium
- Drug: Cytarabine
- Drug: Etoposide
- Drug: Vincristine
Other Study ID Numbers
- TINI
- NCI-2015-01493
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | St. Jude Children's Research Hospital |
| Information Provided By: | St. Jude Children's Research Hospital |
| Last Update Posted: | 2026-06-24 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: ITMHA
- Drug: Dexamethasone
- Drug: Mitoxantrone
- Drug: Pegaspargase
- Drug: Asparaginase Erwinia Chrysanthemi
- Drug: Bortezomib
- Drug: Vorinostat
- Drug: Cyclophosphamide
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Leucovorin Calcium
- Drug: Cytarabine
- Drug: Etoposide
- Drug: Vincristine
Other Study ID Numbers
- TINI
- NCI-2015-01493