Trial · NCT07223190
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 5 years from randomization | |
| Secondary | Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) | Up to 5 years from randomization | Number of participants who experience TEAEs, serious TEAEs, treatment-related adverse events, and adverse events of interest. |
| Secondary | Area Under the Concentration-time Curve in Cycle 1 (AUCcycle 1) for SC Blinatumomab | Up to Cycle 1 Day 35 (Cycle length = 35 days) | |
| Secondary | AUCcycle 1 for cIV Blinatumomab | Up to Cycle 1 Day 35 (Cycle length = 35 days) | |
| Secondary | Average Concentration Following Cycle 1 Day 19 Dosing (Cavgd19dose) for SC Blinatumomab | From predose on Cycle 1 Day 19 to predose on Cycle 1 Day 22 (Cycle length = 35 days) | |
| Secondary | Steady-state Concentration (Css) for cIV Blinatumomab | Up to Cycle 1 Day 29 (Cycle length = 35 days) | |
| Secondary | Relapse-free Survival (RFS) | Up to 5 years from randomization | RFS is defined as time from randomization until relapse, death from any cause or measurable residual disease (MRD) non-response, whichever is earlier. |
| Secondary | Number of Participants With CR With MRD Response | Up to 5 years from randomization | CR with MRD response is defined as MRD \<10\^-4. CR with MRD response is defined as \<5% bone marrow (BM) blasts by cytomorphology with full recovery of peripheral blood counts (absolute neutrophil count \[ANC\] \>1000/µl and platelets \>100,000/µl) and MRD \< 10\^4 and no evidence of extramedullary disease (EMD). |
| Secondary | Number of Participants With Deep CR With MRD Response | Up to 5 years from randomization | Deep CR with MRD response is defined as MRD \<10\^-6. Deep CR with MRD response is defined as \<5% BM blasts by cytomorphology with full recovery of peripheral blood counts (ANC \> 1000/µl and platelets \> 100,000/µl) and MRD ≤ 10\^6 and no evidence of extramedullary disease. |
| Secondary | Change from Day 1 Consolidation Cycle 1 to End of Consolidation in Role Functioning as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days) | |
| Secondary | Change from Day 1 Consolidation Cycle 1 to End of Consolidation in Overall Quality of Life as Measured by EORTC QLQ-C30 | Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days) | |
| Secondary | Change from Day 1 Consolidation Cycle 1 to End of Consolidation in All Other Domains/Items as Measured by EORTC QLQ-C30 | Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days) | |
| Secondary | Change From Day 1 Consolidation Cycle 1 to End of Consolidation in the Visual Analogue Scale (VAS) | Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days) | Change in the VAS will be measured from European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L). |
| Secondary | Percentage of Time on Treatment With High Side Effect Bother From Consolidation Cycle 1 to End of Consolidation | Consolidation Cycle 1 up to Day 8 and then weekly until end of Consolidation Cycle (Cycle length = 35 days) | Percentage of time on treatment with high side effect bother (score 3-4) from consolidation cycle 1 to end of consolidation will be measured by Functional Assessment of Chronic Illness Therapy (FACIT) GP5. |
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/NCT07223190/registered