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Trial · NCT03759184

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Treatment-emergent Adverse Events (AEs) Related to Recombinant Human Interleukin-15 (rhIL-15)28 days or 4 weeks (cycle 1)adverse eventsNUMBER
PRIMARYNumber of Treatment-emergent Adverse Events (AEs) Related to Obinutuzumab28 days or 4 weeks (cycle 1)adverse eventsNUMBER
PRIMARYNumber of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment28 days or 4 weeks (cycle 1)ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment28 days or 4 weeks (cycle 1)ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYMaximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) Administration28 days or 4 weeks (cycle 1)This outcome measure was not done. The MTD was not found because the study was closed after \> 1 year of inactivity and only one participant was enrolled.
PRIMARYMaximum Tolerated Dose (MTD) of Intravenous (IV) Obinutuzumab Treatment28 days or 4 weeks (cycle 1)This outcome measure was not done. The MTD was not found because the study was closed after \> 1 year of inactivity and only one participant was enrolled.
SECONDARYDuration of Response (DOR)time measurement criteria are met for CR, CRi, or PR whichever is recorded first until the first date that recurrent of progressive disease is objectively documented or death, approximately 27 monthsMonthsMEDIAN
SECONDARYOverall Response Rate6 cycles (each cycle is 28 days or 4 weeks)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYEvent-free Survival (EFS)Approximately 8 monthsThere is no confidence interval with 1 sample result.MonthsMEDIAN
SECONDARYOverall Survival (OS)Approximately 27 monthsThere is no full range with 1 sample result.MonthsMEDIAN
SECONDARYProgression-free Survival (PFS)Approximately 8 monthsThere is no full range with 1 sample result.MonthsMEDIAN
OTHER_PRE_SPECIFIEDNumber of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).Date treatment consent signed to date off study, approximately 27 months and 11 days.ParticipantsCOUNT_OF_PARTICIPANTS

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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