Trial · NCT07134088
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs) | Up to 29 days | |
| Primary | Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs) | Up to approximately 7 months | |
| Primary | Phase 1b: Number of Participants who Experienced Serious TEAEs | Up to 2 years and 7 months | |
| Primary | Phase 1b: Number of Participants who Experienced Treatment-related TEAEs | Up to approximately 7 months | |
| Primary | Phase 1b: Number of Participants who Experienced AEs of Interest (EOI) | Up to approximately 7 months | |
| Primary | Phase 2; R Cohort: Number of Participants who had Complete Remission/Complete Remission with Partial Hematological Recovery (CR/CRh) Within the First 2 Cycles | Up to 70 days | |
| Primary | Phase 2; M Cohort: Number of Participants who had CR with MRD Negative Response Within the First 2 Cycles | Up to 70 days | MRD negative response = MRD level \< 10\^-4 (0.01%). |
| Secondary | Phase 1b: Number of Participants who had CR/CRh Within the First 2 Cycles | Up to 70 days | |
| Secondary | Phase 1b: Number of Participants who had CR Within the First 2 Cycles | Up to 70 days | |
| Secondary | Phase 1b: Number of Participants who had CR/CRh/Complete Remission with Incomplete Hematological Recovery (CRi) or Blast Free Hypoplastic or Aplastic Bone Marrow (BM) Within the First 2 Cycles | Up to 70 days | |
| Secondary | Phase 1b: Number of Participants with a MRD Negative Response Within the First 2 Cycles | Up to 70 days | MRD negative response = MRD level \< 10\^-4 (0.01%). |
| Secondary | Phase 1b: Duration of Response (DOR) | Up to 2 years and 7 months | DOR is defined as the time from the first response of CR/CRh within the first 2 cycles until hematological relapse (Including extramedullary \[EM\] relapse) per investigator's assessment or death due to any cause, whichever occurs first. |
| Secondary | Phase 1b: Maximum Concentration (Cmax) of Blinatumomab | Up to approximately 7 months | |
| Secondary | Phase 1b: Time to Maximum Concentration (Tmax) | Up to approximately 7 months | |
| Secondary | Phase 1b: Area Under the Concentration Time Curve (AUC) | Up to approximately 7 months | |
| Secondary | Phase 1b: Number of Participants with Anti-blinatumomab Antibodies | Cycle 1, Day 1 and Cycle 2, Day 1 (Cycle Duration = 35 days) | |
| Secondary | Phase 2: Number of Participants who had CR/CRh with MRD Negative Response Within the First 2 Cycles | Up to 70 days | MRD negative response = MRD level \< 10\^-4 (0.01%). |
| Secondary | Phase 2: DOR | Up to 2 years and 7 months | DOR is defined as the time from the first response of CR/CRh within the first 2 cycles until hematological relapse (Including EM relapse) per investigator's assessment or death due to any cause, whichever occurs first. |
| Secondary | Phase 2; R Cohort: Number of participants who had CR Within the First 2 Cycles | Up to 70 days | |
| Secondary | Phase 2; R Cohort: Number of participants who had CR/CRh/CRi and Blast Free Hypoplastic or Aplastic BM Within the First 2 Cycles | Up to 70 days |
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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GET https://conductscience.org/api/trials/v1/NCT07134088/registered