CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 50 enrolled
Drug / intervention
ITMHA +13 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02553460
NCT02553460Phase 2Active
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Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

St. Jude Children's Research Hospital·interventional·Posted Sep 17, 2015·Updated Jun 24, 2026

In Brief

A Phase 2 clinical trial evaluating ITMHA, Dexamethasone, and 12 other interventions for Acute Lymphoblastic Leukemia. Active but no longer recruiting, targeting 50 participants across 15 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia
CountriesCanada, United States
CollaboratorsGateway for Cancer Research, Baylor College of Medicine

Timeline

Phase 2Active
20162017201820192020202120222023202420252026202720282029203020312032
First PostedSep 17, 2015
Enrollment StartJan 29, 2016
Primary CompletionMay 10, 2022
Study CompletionOct 1, 2031
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 10.8 years ago

Interventions

ITMHAdrug

Given intrathecally (IT).

Dexamethasonedrug

Given orally (PO) or naso-gastrically (NG) or intravenously (IV).

Mitoxantronedrug

Given IV.

Pegaspargasedrug

Given IV. If participant is allergic to pegaspargase, Asparaginase Erwinia Chrysanthemi will be used.

Asparaginase Erwinia Chrysanthemidrug

Asparaginase Erwinia Chrysanthemi will be used in case of allergy or intolerance of participant to PEG-asparaginase. Given IV (preferred) or intramuscularly (IM).

Bortezomibdrug

Given IV.

Vorinostatdrug

Taken PO or NG.

Cyclophosphamidedrug

Given IV.

Mercaptopurinedrug

Given PO or NG.

Methotrexatedrug

Given IV, IM or PO.

Leucovorin Calciumdrug

Leucovorin rescue PO or IV.

Cytarabinedrug

Given IV.

Etoposidedrug

Given IV. In case of participant allergy, etoposide phosphate (Etopophos®) will be given.

Vincristinedrug

Given IV.