Who is sponsoring NCT02553460?

NCT02553460 is sponsored by St. Jude Children's Research Hospital.

What condition does NCT02553460 study?

NCT02553460 studies Acute Lymphoblastic Leukemia.

What drugs are being tested in NCT02553460?

Interventions: ITMHA, Dexamethasone, Mitoxantrone, Pegaspargase, Asparaginase Erwinia Chrysanthemi, Bortezomib, Vorinostat, Cyclophosphamide, Mercaptopurine, Methotrexate, Leucovorin Calcium, Cytarabine, Etoposide, Vincristine.

What is the status of NCT02553460?

NCT02553460 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-12-03 · How we verify

Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

NCT02553460 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING Results posted

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.

Details

Lead sponsor	St. Jude Children's Research Hospital
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	50
Start date	2016-01-29
Completion	2031-10

Conditions

Acute Lymphoblastic Leukemia

Interventions

ITMHA
Dexamethasone
Mitoxantrone
Pegaspargase
Asparaginase Erwinia Chrysanthemi
Bortezomib
Vorinostat
Cyclophosphamide
Mercaptopurine
Methotrexate

Primary outcomes

Percentage of Treatment-related Mortality (TRM) — At the end of reinduction (up to 5 months after start of therapy)
Number of treatment related deaths divided by total number of patients during induction or reinduction therapy. Presented as percentage

Countries

United States, Canada