Trial · NCT03605212
Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults
NCT03605212, Phase 1, Phase 2, Terminated, Menarini Group; results first posted 2021-06-03
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults. Trials, record NCT03605212. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03605212
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults
- NCT number
- NCT03605212
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Menarini Group
- Conditions
- Tumor Lysis Syndrome
- Interventions
- Febuxostat
- First posted
- 2018-07-30
- Last updated
- 2021-06-03
- Other registries' IDs
- eudract:2016-001445-61
- Results first posted
- 2021-06-03
- Limitations and caveats
Data for all outcome measures were not collected due to the paucity of data in the minor patient population and in agreement with EMA with the exceptions of the secondary outcome Assessment of Treatment Emergent Signs and Symptoms (TESS).
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/F) | 7 days | Apparent clearance of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Apparent Volume of Distribution (Vd/F) | 7 days | Apparent volume of distribution of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Absorption Rate Constant (Ka) | 7 days | Absorption rate constant of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Area Under Curve (AUC) | 7 days | AUC of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Maximum Plasma Concentration (Cmax) | 7 days | Maximum plasma concentration of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Tmax | 7 days | Time to Cmax from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Secondary | Pharmacodynamic (PD) Parameter: Area Under the Curve of Serum Uric Acid (sUA) | 8 days | Area under the curve of sUA from baseline (Visit 1, Day 1) to the Evaluation Visit (Visit 8, Day 8) (AUC sUA 1-8) |
| Secondary | Assessment of Laboratory Tumor Lysis Syndrome (LTLS) | 7 days | Assessment of LTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). LTLS is diagnosed if levels of 2 or more values of uric acid, potassium, phosphate or calcium are more than or less than normal at presentation or if they change by at least 25% from baseline. |
| Secondary | Assessment of Clinical Tumor Lysis Syndrome (CTLS) | 7 days | Assessment of CTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). CTLS is present when LTLS is accompanied by at least one of the following significant clinical complications: increased creatinine level ≥ 1.5 upper limit of normal, cardiac arrhythmia/sudden death or seizure. |
| Secondary | Assessment of Treatment Emergent Signs and Symptoms (TESS) | Estimated maximum time frame: 27 days | Assessment of incidence, severity (through Mild/Moderate/Severe scale), seriousness and treatment-causality of TESS from Screening Visit to End of Study Visit. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. An adverse event was considered as TESS if it occured for the first time or if it worsened in terms of seriousness or severity after first study drug intake. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/F) | 7 days | Data were not collected. | ||
| PRIMARY | PK Parameter: Apparent Volume of Distribution (Vd/F) | 7 days | Data were not collected. | ||
| PRIMARY | PK Parameter: Absorption Rate Constant (Ka) | 7 days | Data were not collected. | ||
| PRIMARY | PK Parameter: Area Under Curve (AUC) | 7 days | Data were not collected. | ||
| PRIMARY | PK Parameter: Maximum Plasma Concentration (Cmax) | 7 days | Data were not collected. | ||
| PRIMARY | PK Parameter: Tmax | 7 days | Data were not collected. | ||
| SECONDARY | Pharmacodynamic (PD) Parameter: Area Under the Curve of Serum Uric Acid (sUA) | 8 days | Data were not collected. | ||
| SECONDARY | Assessment of Laboratory Tumor Lysis Syndrome (LTLS) | 7 days | Data were not collected. | ||
| SECONDARY | Assessment of Clinical Tumor Lysis Syndrome (CTLS) | 7 days | Data were not collected. | ||
| SECONDARY | Assessment of Treatment Emergent Signs and Symptoms (TESS) | Estimated maximum time frame: 27 days | Safety population | Events | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Cohort 1 | TESS | 50 | Events | |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Cohort 3 | TESS | 21 | Events | |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Adults | TESS | 70 | Events | |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Cohort 1 | TESS grade >/=3 | 11 | Events | |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Cohort 3 | TESS grade >/=3 | 2 | Events | |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Adults | TESS grade >/=3 | 20 | Events | |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Cohort 1 | Serious TESS | 1 | Events | |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Cohort 3 | Serious TESS | 0 | Events | |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Adults | Serious TESS | 7 | Events | |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Cohort 1 | Related TESS | 4 | Events |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline Period | STARTED | Cohort 1 | 3 | |
| Baseline Period | STARTED | Cohort 2 | 0 | |
| Baseline Period | STARTED | Cohort 3 | 3 | |
| Baseline Period | STARTED | Cohort 4 | 0 | |
| Baseline Period | STARTED | Adults | 24 | |
| Baseline Period | COMPLETED | Cohort 1 | 3 | |
| Baseline Period | COMPLETED | Cohort 2 | 0 | |
| Baseline Period | COMPLETED | Cohort 3 | 3 | |
| Baseline Period | COMPLETED | Cohort 4 | 0 | |
| Baseline Period | COMPLETED | Adults | 24 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events390
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hot flush | Vascular disorders | Cohort 1 | 0 | 3 | 0 |
| other | Hot flush | Vascular disorders | Cohort 2 | 0 | 0 | 0 |
| other | Hot flush | Vascular disorders | Cohort 3 | 1 | 3 | 1 |
| other | Hot flush | Vascular disorders | Cohort 4 | 0 | 0 | 0 |
| other | Hot flush | Vascular disorders | Adults | 0 | 24 | 0 |
| other | Hypotension | Vascular disorders | Cohort 1 | 0 | 3 | 0 |
| other | Hypotension | Vascular disorders | Cohort 2 | 0 | 0 | 0 |
| other | Hypotension | Vascular disorders | Cohort 3 | 0 | 3 | 0 |
| other | Hypotension | Vascular disorders | Cohort 4 | 0 | 0 | 0 |
| other | Hypotension | Vascular disorders | Adults | 1 | 24 | 1 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 1 | 3 |
| Total, all-cause mortality | Cohort 2 | 0 | 0 |
| Total, all-cause mortality | Cohort 3 | 0 | 3 |
| Total, all-cause mortality | Cohort 4 | 0 | 0 |
| Total, all-cause mortality | Adults | 0 | 24 |
| Total, other adverse events | Cohort 1 | 3 | 3 |
| Total, other adverse events | Cohort 2 | 0 | 0 |
| Total, other adverse events | Cohort 3 | 3 | 3 |
| Total, other adverse events | Cohort 4 | 0 | 0 |
| Total, other adverse events | Adults | 20 | 24 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03605212
GET https://conductscience.org/api/trials/v1/NCT03605212/results?page=2