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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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 facts

Study ID: NCT02553460
Run by: St. Jude Children's Research Hospital
People needed: 50
Starts: 2016-01-29
Expected to finish: 2031-10-01
Last updated by the study team: 2026-06-24

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is ≤ 365 days of age at the time of diagnosis.
Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid.
Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy.
Written informed consent following Institutional Review Board, NCI, FDA, and Office for Human Research Protections (OHRP) Guidelines.

You may not qualify if…

Patients with prior therapy, other than therapy specified in the Inclusion Criteria.
Patients with mature B-cell ALL or acute myelogenous (AML).
Patients with Down syndrome.
Inability or unwillingness of legal guardian/representative to give written informed consent.

Where it is running

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

Full record on ClinicalTrials.gov

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