Trial · NCT05327894
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
NCT05327894, Phase 3, Recruiting, Princess Maxima Center for Pediatric Oncology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia. Trials, record NCT05327894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05327894
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
- NCT number
- NCT05327894
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 160 participants, estimated
- Lead sponsor
- Princess Maxima Center for Pediatric Oncology
- Conditions
- Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
- Interventions
- Blinatumomab, Blinatumomab
- First posted
- 2022-04-14
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event free survival (EFS). | 5 years | The primary endpoint is EFS, defined as the time from diagnosis to resistance to induction, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up (censored) for patients without events. |
| Secondary | Overall survival | 8 years | The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy. |
| Secondary | Endpoints by risk group | 8 years | The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy. |
| Secondary | Outcome for the entire study cohort and according to risk group | 8 years | Outcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated. |
| Secondary | Minimal Residual Disease | 8 years | MRD response as defined in the protocol and frequencies of MRD levels |
| Secondary | CD19 (cluster of differentiation antigen 19) negative relapse | 8 years | Proportion of CD19 negative relapses in the entire study cohort and according to risk group |
| Secondary | Myeloid lineage switches | 8 years | Proportion of myeloid lineage switches in the entire study cohort and according to risk group |
| Secondary | Grade ≥3 adverse event | 8 years | Proportion of grade ≥3 adverse event (AEs) during the blinatumomab course(s). Proportion of adverse events of special interest (AESIs) and serious adverse events (SAEs) in all protocol phases. |
| Secondary | Grade ≥2 cardiac disorders | 5 years | Proportion of grade ≥2 cardiac disorders at 2 and 5 years after diagnosis |
| Secondary | Overall survival after 1st relapse | 8 years | Overall survival (OS) after first relapse, defined as the time from first relapse to death from any cause, in the entire study cohort and according to risk group |
Source ClinicalTrials.gov
Outcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41671463 | DERIVED |
Source PubMed
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/NCT05327894
GET https://conductscience.org/api/trials/v1/NCT05327894/registered