Clinical trial · Interventional
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asparaginase Erwinia Chrysanthemi | Drug | — | UNRESOLVED |
| Bortezomib | Drug | Bortezomib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| ITMHA | Drug | — | UNRESOLVED |
| Leucovorin Calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Participants who meet eligibility requirements will receive remission induction, consolidation treatment, reinduction, reintensification and maintenance therapy. Interventions: ITMHA, dexamethasone, mitoxantrone, pegaspargase or asparaginase Erwinia chrysanthemi, bortezomib, vorinostat, cyclophosphamide, mercaptopurine, methotrexate, leucovorin calcium, cytarabine, etoposide, and vincristine.
- interventionNames
- Drug: ITMHA
- Drug: Dexamethasone
- Drug: Mitoxantrone
- Drug: Pegaspargase
- Drug: Asparaginase Erwinia Chrysanthemi
- Drug: Bortezomib
- Drug: Vorinostat
- Drug: Cyclophosphamide
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Leucovorin Calcium
- Drug: Cytarabine
- Drug: Etoposide
- Drug: Vincristine
Primary outcomes (1)
- measure
- Percentage of Treatment-related Mortality (TRM)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 365 Days
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGruber 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. PMID 41692013