Trial · NCT01564784
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) | Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose | ITT218 population - included the ITT population (all participants randomized) for the initial 218 participants. | Percentage of Participants | NUMBER |
| PRIMARY | Overall Survival (OS) | Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first. | ITT population - included all participants randomized. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Months | MEDIAN |
| SECONDARY | Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) | Up to 2 years from randomization | Participants in the ITT218 population who achieved CR/CRi | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Up to 2 years from randomization | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) | Up to 19 weeks from last dose | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment) | Up to approximately 4 weeks (EoT) from last dose of study drug | Participants in the ITT218 population achieving CR/CRi (per EAC Assessment) | Percentage of Participants | NUMBER |
| SECONDARY | Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment) | Up to approximately 4 weeks (EoT) from last dose of study drug | Participants in the ITT218 population who had abnormal cytogenetics at baseline and who achieved CR/CRi | Percentage of Participants | NUMBER |
| SECONDARY | Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing | Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4 | Pharmacokinetic (PK) evaluable population - included all participants with available PK data. | ng/mL | MEAN |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score | Day 1 of each cycle prior to dosing and EoT | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score | Day 1 of each cycle prior to dosing and EoT | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in EQ-5D VAS | Day 1 of each cycle prior to dosing and EoT | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Score on a scale | MEAN |
| SECONDARY | Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT | Up to 2 years from randomization | Participants in the Safety population with post-study HSCT. A site visit in July 2017 (after clinical database lock), confirmed a fourth case of VOD/SOS occurred in the Defined Investigators Choice of Chemotherapy arm in March 2013 (approximately 3 months after the last dose).This was not entered on the CRF and therefore, is not included below. | Percentage of Participants | NUMBER |
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.
For software
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