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Trial · NCT01644253

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryIncidence and severity of adverse eventsany time point during the study up to 18 months
PrimaryCLL Cysteine 481 mutation statusCLL patients in Cohort 7 will be followed for 9 months unless no cysteine 481 mutation is detected.The primary endpoint for Cohort 7 is the elimination of the cysteine 481 mutant clone (\<1%).
SecondaryOverall Response Rate (ORR)any time point during the study up to 18 months
SecondaryProgression-free survival (PFS)any time point during the study up to 18 months
SecondaryOverall survival (OS)any time point during the study up to 18 months
SecondaryDuration of response (DOR)any time point during the study up to 18 months
SecondaryResolution of disease-related symptomsany time point during the study up to 18 months
Resolution of disease-related symptoms which are common to the disease include fever, weight loss, night sweats, fatigue, loss of appetite pain, and pruritus; symptoms will be assessed by descriptive statistics and data listings.
SecondaryMaximum serum drug concentration (Cmax)any time point during the study up to 12 months
SecondaryMinimum serum drug concentration (Cmin)any time point during the study up to 12 months
SecondaryArea under the concentration-time curve (AUC0-t and AUC0-∞)any time point during the study up to 12 months
SecondarySystemic clearance (CL)any time point during the study up to 12 months
SecondaryVolume of distribution (Vd)any time point during the study up to 12 months
SecondaryElimination half-life (t1/2)any time point during the study up to 12 months

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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