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NCT05106296

Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 12 versions: 10 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Sep 30, 2028 to Dec 28, 2029
    • Eligibility criteria expanded, about 21 words
    • Publications: details revised at 2 of 2 entries
  2. Primary completion date: Aug 2026 to Mar 30, 2028v11 Show 4 more changesShow less
    • Primary endpoints: 2 to 4
    • Study completion date: Sep 2026 to Sep 30, 2028
    • Interventions: Cyclophosphamide (Drug), Etoposide (Drug), Ibrutinib (Drug), Indoximod (Drug) to Cyclophosphamide (Drug), Etoposide (Drug), Ibrutinib (Drug), Ibrutinib (Drug), Indoximod (Drug), Temozolomide (Drug)
    • Study arms: 1 to 2
  3. Site contact updatedv10
  4. Collaborators: 1 to 3v9
  5. Site contact updatedv7
Show 4 earlier versionsHide 4 earlier versions
  1. Site contact updatedv6
  2. Publications revised (2)v5
  3. Primary completion date: Mar 2025 to Aug 2026
    • Study completion date: Apr 2025 to Sep 2026
    • Secondary endpoints: details revised at 3 of 8 entries
    • Eligibility criteria shortened, about 4 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2022 to Feb 8, 2022
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of regimen-limiting toxicity (RLT) for Regimen A
Timeframe: First 90 days of treatment
Objective Response Rate (ORR) for Regimen A
Timeframe: Up to 5 years
Incidence of regimen-limiting toxicity (RLT) for Regimen B
Timeframe: First 90 days of treatment
Objective Response Rate (ORR) for Regimen B
Timeframe: Up to 5 years

Secondary (8)

Adverse events (AEs)
Frequency of cycle delays for toxicity
Frequency of dose-reductions of the chemotherapy regimen
Complete Response Rate (CRR)
Partial Response Rate (PRR)
Show 3 moreShow less
Modified Objective Response Rate (mORR)
iRANO-PFS
Overall Survival (OS)

Arms and interventions

Regimen AExperimental

Patients will be treated with ibrutinib plus indoximod, cyclophosphamide, and etoposide. Cycles are a minimum of 28 days.

Regimen BExperimental

Patients will be treated with ibrutinib plus indoximod and temozolomide. Cycles are a minimum of 28 days.

Drugs: Indoximod, Ibrutinib, Cyclophosphamide, Etoposide, Temozolomide

Sites

1 site in 1 country

  • Augusta University, Georgia Cancer CenterAugusta, Georgia, United States