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

• Status: Recruiting
• Trial end date: 2031-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborators: Baylor College of Medicine; Gateway for Cancer Research; Texas Children's Hospital
• Treatments: 6-Mercaptopurine; Asparaginase; BB 1101; Bortezomib; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate; Hydrocortisone; Leucovorin; Levoleucovorin; Mercaptopurine; Methotrexate; Mitoxantrone; Pegaspargase; Vincristine; Vorinostat

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.