Trial · NCT01117441
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia
NCT01117441, Phase 3, Completed, University Hospital Schleswig-Holstein
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Trials, record NCT01117441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01117441
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia
- NCT number
- NCT01117441
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,136 participants, actual
- Lead sponsor
- University Hospital Schleswig-Holstein
- Conditions
- Leukemia
- Interventions
PEG-L-asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone, doxorubicin hydrochloride, etoposide, ifosfamide, mercaptopurine, methotrexate, prednisone, thioguanine, vincristine sulfate, vindesine, daunoxome, fludarabine, Radiation Therapy
- First posted
- 2010-05-05
- Last updated
- 2022-05-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free survival | 10 years from the start of recruitment | * Randomization R1: Event-free survival from time of randomization * Historical comparison non-HR T-ALL: Event-free survival from diagnosis * Historical comparison "MRD Non-Responders": Event-free survival from start of DNX-FLA (morphological non-response after HR-3' is no event for this study question) |
| Primary | Disease-free survival | 10 years from the start of recruitment | * Randomization R2: Disease-free survival from time of randomization * Historical comparison SR: Disease-free survival from start of Protocol M |
| Primary | minimal residual disease (MRD) | week 12 of treatment | Randomization RHR: rate of MRD highly positive patients (MRD ≥ 10-3) at TP2 (week 12) |
| Secondary | survival | 10 years from the start of recruitment | All randomized and historical comparisons: Survival |
| Secondary | treatment-related mortality | up to 25 months from the diagnosis | All randomized and historical comparisons: treatment-related mortality in induction or CCR (overall and by chemotherapy/SCT) |
| Secondary | adverse events | up to 25 months from the diagnosis | All randomized and historical comparisons: incidence and frequency of adverse events of interest and serious adverse events |
| Secondary | event-free survival | 10 years from the start of recruitment | Randomization R-HR: Event-free survival from time of randomization |
| Secondary | minimal residual disease | after 24 weeks of treatment | "MRD Non-Responders": MRD levels after DNX-FLA |
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.
Papers11
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/NCT01117441
GET https://conductscience.org/api/trials/v1/NCT01117441/registered