Trial · NCT02333058
Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies
NCT02333058, Phase 2, Completed, medac GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies. Trials, record NCT02333058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02333058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies
- NCT number
- NCT02333058
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- medac GmbH
- Conditions
- Acute Lymphoblastic Leukaemias (ALL), Acute Myeloid Leukaemias (AML), Myelodysplastic Syndromes (MDS), Juvenile Myelomonocytic Leukaemias (JMML)
- Interventions
- Treosulfan
- First posted
- 2015-01-07
- Last updated
- 2020-05-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Freedom from transplant (treatment)-related mortality (TRM) | from the day of first administration of study medication until day +100 after HSCT | TRM is defined as death from any transplant-related cause |
| Secondary | Engraftment after HSCT | until engraftment | Engraftment is defined as first of three consecutive days for each of the following four criteria: * a leukocyte count of more than 1 x 109/L * an absolute neutrophil count (ANC) of more than 0.5 x 109/L * a platelet count of at least 20 x 109/L in the absence of platelet transfusion * a platelet count of at least 50 x 109/L in the absence of platelet transfusion |
| Secondary | Safety including early toxicity until day +100 after HSCT, serious adverse reactions (SARs) until the end of the longer-term follow-up phase | until 12 months after HSCT | based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 |
| Secondary | Hepatic sinusoidal obstruction syndrome (HSOS), lung toxicity (CTCAE term pulmonary fibrosis), hepatic toxicity and infections of any CTCAE grade (non-serious and serious) | until day +100 after HSCT | |
| Secondary | Donor-type chimerism | on day +28, day +100 and 12 months after HSCT | The incidences of complete donor-type chimerism will be estimated as the number of patients with complete chimerism divided by the total number of patients at risk. |
| Secondary | Non relapse mortality (NRM), transplant related mortality (TRM), graft failure rate, incidence of relapse/progression, relapse-free/progression-free survival (RFS/PFS) and overall survival (OS) | after 12 months after HSCT and until the end of the longer-term follow-up phase | Non-relapse mortality will be defined as the probability of dying in the absence of persisting disease or previous occurrence of relapse/progression or graft failures. TRM is defined as the probability of dying from a transplant-related cause. The associated time span is defined as the interval from day 0 to death due to a transplant-related cause. The incidence of relapse/progression is defined as the probability of having relapse/progression of the underlying disease. Relapse-free/progression-free survival is defined as the time length between day 0 and the date of relapse/progression of the underlying disease or death due to any cause. OS after HSCT is defined as the probability of surviving. Survival time is defined as the time period between day 0 and the day of death due to any cause. Kaplan-Meier methods will be applied for estimating the probability of these parameters over time. |
| Secondary | Incidence and severity of acute (until day +100) and chronic (until 12 months after HSCT) graft versus host disease (aGvHD/cGvHD) | until 12 months after HSCT | The probability of grade I-IV and grade III-IV aGvHD will be estimated by cumulative incidence rates and summarised for selected time points together with their approximate 90 % confidence intervals. As for aGvHD, the probability of cGvHD will be estimated by cumulative incidence rates. |
| Secondary | Use of rescue therapies including donor-lymphocyte infusions (DLIs) and further conditioning regimens | until 12 months after HSCT | |
| Secondary | PK parameters of Treosulfan and its epoxides | day -6 prior to HSCT | The following PK parameters of Treosulfan and its epoxides will be measured: Clearance (CL); volume of distribution (Vss); terminal elimination rate constant (λz); terminal elimination half-life (t1/2); area under the concentration time curve from time zero to infinity (AUC∞); maximum observed concentration (Cmax, i.e. C end of infusion). |
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 |
|---|---|
| 32203268 | 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/NCT02333058
GET https://conductscience.org/api/trials/v1/NCT02333058/registered