Trial · NCT02101853
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients | Up to 2 years from date of randomization | HR and IR patients randomized per protocol prior to June 30, 2019. This is the cohort of patients who were included in the primary analysis addressing the primary objective on HR/IR patients. Of the total of 216 randomized HR/IR patients, 2 patients with randomization procedure errors and 6 patients randomized after June 30, 2019 were excluded. | percentage of participants | NUMBER |
| PRIMARY | Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients | Up to 3 years from date of randomization | LR patients randomized per protocol. This is the cohort of patients who were included in the primary analysis addressing the primary objective on LR patients. Of the total of 256 randomized LR patients, 1 patient was found to be ineligible and was excluded. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) of HR and IR Relapse Patients | Up to 2 years from date of randomization | HR and IR patients randomized per protocol prior to June 30, 2019. This is the cohort of patients who were included in the primary analysis addressing the primary objective on HR/IR patients. Of the total of 216 randomized HR/IR patients, 2 patients with randomization procedure errors and 6 patients randomized after June 30, 2019 were excluded. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) of LR Relapse Patients | Up to 3 years from date of randomization | LR patients randomized per protocol. This is the cohort of patients who were included in the primary analysis addressing the primary objective on LR patients. Of the total of 256 randomized LR patients, 1 patient was found to be ineligible and was excluded. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Rates of Minimal Residual Disease (MRD) Positivity (> 0.01%) | Up to 12 weeks | |||
| OTHER_PRE_SPECIFIED | Hematologic Complete Remission Rate (for Treatment Failure Patients Not Previously Receiving Blinatumomab) | Up to 12 weeks | |||
| OTHER_PRE_SPECIFIED | MRD Negativity (< 0.01%) Rate (for Treatment Failure Patients Not Previously Receiving Blinatumomab) | Up to 12 weeks | |||
| OTHER_PRE_SPECIFIED | Proportion of Patients That Proceed to Hematopoietic Stem Cell Transplant (HSCT) After Treatment With Blinatumomab (for Treatment Failure Patients Not Previously Receiving Blinatumomab) | Up to 12 weeks | |||
| OTHER_PRE_SPECIFIED | Feasibility of Rapid Taper of Immune Suppression for Subset of HSCT Patients With MRD >= 0.01% Pre- and/or Post-HSCT With no Acute Graft Versus Host Disease (aGVHD) | Up to 10 years | |||
| OTHER_PRE_SPECIFIED | Safety of Rapid Taper of Immune Suppression for Subset of HSCT Patients With MRD >= 0.01% Pre- and/or Post-HSCT With no aGVHD Defined as < 5% Rate of Treatment-related Mortality (TRM) | Up to 10 years | |||
| OTHER_PRE_SPECIFIED | Blinatumomab Pharmacokinetics (PK) | Days 2 and 14 of cycle 1 |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02101853/outcomes