Clinical Research Directory
Browse clinical research sites, groups, and studies.
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
Sponsor: St. Jude Children's Research Hospital
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.
Key Details
Gender
All
Age Range
Any - 365 Days
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2016-01-29
Completion Date
2031-10
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
ITMHA
Given intrathecally (IT).
Dexamethasone
Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
Mitoxantrone
Given IV.
Pegaspargase
Given IV. If participant is allergic to pegaspargase, Asparaginase Erwinia Chrysanthemi will be used.
Asparaginase Erwinia Chrysanthemi
Asparaginase Erwinia Chrysanthemi will be used in case of allergy or intolerance of participant to PEG-asparaginase. Given IV (preferred) or intramuscularly (IM).
Bortezomib
Given IV.
Vorinostat
Taken PO or NG.
Cyclophosphamide
Given IV.
Mercaptopurine
Given PO or NG.
Methotrexate
Given IV, IM or PO.
Leucovorin Calcium
Leucovorin rescue PO or IV.
Cytarabine
Given IV.
Etoposide
Given IV. In case of participant allergy, etoposide phosphate (Etopophos®) will be given.
Vincristine
Given IV.
Locations (15)
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States
St. Jude Affiliate-Charlotte
Charlotte, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Children's Hospital of the King's Daughters (CHKD)
Norfolk, Virginia, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
The Montreal Children's Hospital (MUHC-McGill)
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada