Trial · NCT03643276
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
NCT03643276, Phase 3, Recruiting, Martin Schrappe
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017. Trials, record NCT03643276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03643276
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
- NCT number
- NCT03643276
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 5,000 participants, estimated
- Lead sponsor
- Martin Schrappe
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Interventions
Blinatumomab, Bortezomib, Cyclophosphamide, Cytarabine, Daunorubicin, Myocet, Dexamethasone, Doxorubicin, Etoposide, Fludarabine Phosphate, Ifosfamide, 6-Mercaptopurine, Methotrexate, Pegaspargase, Prednisolone, Tioguanin, Vincristine, Vindesine, Erwinase
- First posted
- 2018-08-22
- Last updated
- 2025-04-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free survival | Assessed up to 120 months from start of study | Randomization R-eHR, R-HR and R-T: Time from randomization until the first event defined as follow: cytomorphological or molecular non-response (resistance to protocol treatment, considered as event at day zero), relapse, second malignancy or death from any cause. This will be called EFS time. |
| Primary | Disease-free survival | Assessed up to 120 months from start of study | Randomization R-MR: Time from randomization until the first event defined as follow: Relapse, second malignancy or death from any cause. This will be called DFS time. |
| Secondary | Survival | Assessed up to 120 months from start of study | All patients/randomizations: Time until death from any cause, starting at the same time point as the EFS/DFS. |
| Secondary | Treatment-related mortality | Assessed up to 120 months from start of study | Frequency and incidence of treatment-related mortality in induction or continuous complete remission |
| Secondary | Adverse Events of interest/Serious Adverse Events | Assessed up to 120 months from start of study | Frequency and incidence of adverse events of interest and serious adverse events in specific protocol phases, randomized arms and overall during follow-up |
| Secondary | MRD response | Measurements of MRD response at end of randomized treatments (intended time frame 13 weeks in R-eHR/R-T, 26 weeks in R-HR, 34 weeks in R-MR). | MRD load after the randomized treatment phases (R-eHR, R-HR, R-MR and R-T) as well as after the first/second cycle of Blinatumomab or after the HR 2'/HR 3' block (R-HR) |
| Secondary | Proportion of patients with Blina Poor-Response | Measurements of MRD response intended after 30 weeks from individual start of treatment, assessment of proportion at 120 months from start of study | Proportion of patients with poor MRD response to the first Blinatumomab cycle ("Blinatumomab Poor-Response") (R-HR) |
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.
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT03643276
GET https://conductscience.org/api/trials/v1/NCT03643276/registered