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

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.

Timeline

Start

2016-01-29

Primary completion

2022-05-10

Completion

2031-10

Publications

• Gruber TA, Jeha S, Deyell RJ, Lewis V, Chang BH, Lowe EJ, Frediani J, Vezina C, Michon B, Richards M, Breese EH, Tran TH, Lacayo N, Bolen C, Desai S, Pauley JL, Huang M, Ashcraft E, Cheng C, Schultz KR, Stork L, Schlis K, Huynh VT, Gossai N, Messinger YH, Bittencourt H, Horton TM, Athale U, Stearns D, Schiff D, Gaynon PS. Bortezomib and vorinostat in combination with mitoxantrone, dexamethasone, and pegasparaginase during induction and reinduction for infants with acute lymphoblastic leukaemia: a multicentre single-arm phase 1/2 study. Lancet Haematol. 2026 Mar;13(3):e144-e156. doi: 10.1016/S2352-3026(25)00357-6. Epub 2026 Feb 12.

Drugs

Indications