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Trial · NCT07297914

Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL

NCT07297914, Phase 2, Phase 3, Recruiting, Bambino Gesù Hospital and Research Institute

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL. Trials, record NCT07297914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07297914

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL
NCT number
NCT07297914
Status
Recruiting
Phases
Phase 2, Phase 3
Enrollment
1,000 participants, estimated
Lead sponsor
Bambino Gesù Hospital and Research Institute
Conditions
Acute Lymphoblastic Leukemia (ALL), Stem Cell Transplant, Graft -Versus-host-disease
Interventions
Total Body Irradiation 8 Gy, Ruxolitinib, Blinatumomab, Cyclophosphamide, Total Body Irradiation 12 Gy, Corticosteroids, αβ T-cells depletion
First posted
2025-12-22
Last updated
2026-10-20

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEvent Free Survival (EFS)at year 4
EFS is defined as the time from randomization (intention-to-treat analysis) or HSCT (per-protocol/as treated) to first failure event defined as follows: Failure events are: * Relapse * Graft failure * Death from any cause * Diagnosis of a second malignant neoplasm
PrimaryOverall response rate (ORR) at day 28day 28
Overall response rate (ORR) at day 28 after randomization, defined as the proportion of patients in each arm demonstrating a complete response (CR) or partial response (PR) without requirement for additional systemic therapies for earlier progression, mixed response or nonresponse.
PrimaryEvent Free Survival (EFS)at year 4EFS is defined as the time from HSCT to first failure event defined as follows: Failure events are: * Relapse * Graft failure * Death from any cause * Diagnosis of a second malignant neoplasm
PrimaryCumulative incidence of relapse (CIR) at 2 years after HSCT2 years after HSCT
CIR at 2 years after HSCT in blinatumomab-treated patents and historical controls. CIR is calculated from the time of study enrolment until the date of relapse (defined as either bone marrow aspirate or biopsy with ≥ 5% blasts or as appearance of leukemia cells in an extramedullary site) or last follow-up (death from any cause other than leukemia relapse and secondary malignancies will be considered a competing event)

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.

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
33332189BACKGROUNDPubMed
37738088BACKGROUNDPubMed
38721739BACKGROUNDPubMed
39602342BACKGROUNDPubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT07297914

GET https://conductscience.org/api/trials/v1/NCT07297914/registered