Trial · NCT07223190
A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia
NCT07223190, Phase 3, Not yet recruiting, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia. Trials, record NCT07223190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07223190
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia
- NCT number
- NCT07223190
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 560 participants, estimated
- Lead sponsor
- Amgen
- Conditions
- Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia
- Interventions
- Blinatumomab, Blinatumomab, HyperCVAD
- First posted
- 2025-10-31
- Last updated
- 2026-09-15
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07223190
GET https://conductscience.org/api/trials/v1/NCT07223190/registered