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Trial · NCT02835729

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySafety assessed by development of RLT, AEs and laboratory parameters of indoximod.6 monthsPhase 1
PrimaryComparison of serum concentrations (Cmax/Steady State) of indoximod freebase and indoximod salt formulation.6 monthsPhase 1
SecondaryMeasurable Residual Disease Rate2 years
SecondaryClinical response rate2 years
SecondaryDuration of complete response2 years
SecondaryEvent free survival2 yearsTime on study to induction failure, relapse or death
SecondaryCumulative incidence of relapse (CIR)2 years
SecondaryOverall survival (OS)2 years
SecondaryProportion of AML patients who become eligible for bone marrow transplantation2 years
SecondaryFrequency and severity of adverse events2 years
SecondaryPharmacokinetics: Serum concentrations (Cmax/Steady State)6 monthsCharacterize the pharmacokinetics (PK) of indoximod, idarubicin and cytarabine through analysis of blood samples
OtherSerum kynurenine and tryptophan levels2 yearsCharacterize the pharmacodynamic (PD) effect of indoximod
OtherIDO expression by immunohistochemistry in diagnostic and follow-up bone marrow biopsy specimens2 years
OtherIDO protein and mRNA expression in diagnostic and follow-up bone marrow aspirate samples2 years
OtherMethylation status of the IDO promoter in diagnostic and follow up bone marrow aspiration samples2 years

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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