CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 24 enrolled
Drug / intervention
Ixazomib +7 moredrug
Likely dose
Vincristine 1.5mg/m2from 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/NCT03817320
NCT03817320Phase 2Active
CompareCT.gov

A TACL Phase 1/2 Study of PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma IND# 140730

Therapeutic Advances in Childhood Leukemia Consortium·interventional·Posted Jan 25, 2019·Updated Jun 17, 2025

In Brief

A Phase 2 clinical trial evaluating Ixazomib, Vincristine, and 6 other interventions for ALL, Childhood and 2 related conditions. Active but no longer recruiting, targeting 24 participants across 18 sites in 2 countries.

Detailed Summary

This is a phase 1/2 study of a drug called Ixazomib in combination with cytotoxic chemotherapy consisting of Vincristine, Dexamethasone, Asparaginase, and Doxorubicin (VXLD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALL, Childhood, Lymphoblastic Lymphoma, Childhood, Lymphoblastic Leukemia, Acute, Childhood
CountriesAustralia, United States
CollaboratorsTakeda, Children's Hospital Los Angeles

Timeline

Phase 2ActiveOverdue
20192020202120222023202420252026
First PostedJan 25, 2019
Enrollment StartFeb 12, 2019
Primary CompletionDec 3, 2023
Study CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.4 years ago

Interventions

Ixazomibdrug

Days 1, 4, 8, and 11. Note: at least 72 hours must have elapsed between doses Dose Phase 1 - Assigned upon study entry. Phase 2 - PO formulation at RP2D

Vincristinedrug

IV push over 1 minute or infusion via minibag as per institutional policy Days 1, 8, 15 and 22 Dose: ≥ 1 year: 1.5mg/m2/dose (maximum dose 2mg) ≥ 6 months and \< 1 year: 1.2mg/m2/dose \< 6 months: 1mg/m2/dose

Dexamethasonedrug

Days 1-14 Dose: ≥ 1 year: 10mg/m2/day, divided BID (i.e., 5mg/m2/dose, BID) ≥ 6 months and \< 1 year: 8mg/m2/day, divided BID (i.e., 4 mg/m2/dose, BID) \< 6 months: 7mg/m2/day, divided BID (i.e., 3.5 mg/m2/dose, BID)

Asparaginasedrug

Days 2, 15 Dose ≥ 1 year: 2,500 International units (IU)/m2/dose ≥ 6 months and \< 1 year: 2,000 IU/m2/dose \< 6 months: 1,750 IU/m2/dose Patient with allergic reaction to Pegaspargase can be given Erwinase IM/IV on Mon/Wed/Fri (or every other day per institutional standard) x 6 doses for each dose of Pegaspargase. Dosing guideline for Erwinase: * 1 year: 25,000 IU/m2/dose * 6 months and \< 1 year: 20,000 IU/m2/dose \< 6 months: 17,500 IU/m2/dose

Doxorubicindrug

Day 1 Dose ≥ 1 year: 60mg/m2/dose ≥ 6 months and \< 1 year: 48 mg/m2/dose \< 6 months: 42mg/m2/dose

Methotrexate (IT)drug

For patients with CNS 1 or CNS 2, on Days 1, 15, and 29

Triple IT (Methotrexate, Hydrocortisone, Cytarabine)drug

For patients with CNS 3, on Days 1, 8, 15, 22, and 29

Leucovorindrug

For patients with Down syndrome only, on Days 2, 9, 16, 23, and 30 (based on dates when IT Methotrexate or Triple IT is given)