Trial · NCT00628628
Rasburicase in Patients at Risk for Tumor Lysis Syndrome
NCT00628628, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2013-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rasburicase in Patients at Risk for Tumor Lysis Syndrome. Trials, record NCT00628628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00628628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rasburicase in Patients at Risk for Tumor Lysis Syndrome
- NCT number
- NCT00628628
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 82 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Tumor Lysis Syndrome
- Interventions
- As Needed Rasburicase, Fixed Dose Rasburicase
- First posted
- 2008-03-05
- Last updated
- 2013-08-01
- Results first posted
- 2013-08-01
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Plasma Uric Acid (UA) Response | First cycle of chemotherapy, up to 5 days | Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Plasma Uric Acid (UA) Response | First cycle of chemotherapy, up to 5 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Plasma Uric Acid (UA) Response | Group A: Single Dose | 39 | participants | ||
| Number of Participants With Plasma Uric Acid (UA) Response | Group B: Daily Dose | 34 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A: Single Dose | 40 | |
| Overall Study | STARTED | Group B: Daily Dose | 40 | |
| Overall Study | COMPLETED | Group A: Single Dose | 40 | |
| Overall Study | COMPLETED | Group B: Daily Dose | 40 | |
| Overall Study | NOT COMPLETED | Group A: Single Dose | 0 | |
| Overall Study | NOT COMPLETED | Group B: Daily Dose | 0 |
Source ClinicalTrials.gov
Adverse events24
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 | Methemoglobinemia | Blood and lymphatic system disorders | Group A: Single Dose | 0 | 40 | |
| other | Methemoglobinemia | Blood and lymphatic system disorders | Group B: Daily Dose | 1 | 40 | |
| other | Hemolysis | Blood and lymphatic system disorders | Group A: Single Dose | 1 | 40 | |
| other | Hemolysis | Blood and lymphatic system disorders | Group B: Daily Dose | 0 | 40 | |
| other | Clinical tumor lysis syndrome | Metabolism and nutrition disorders | Group A: Single Dose | 0 | 40 | |
| other | Clinical tumor lysis syndrome | Metabolism and nutrition disorders | Group B: Daily Dose | 3 | 40 | |
| other | Laboratory tumor lysis syndrome | Metabolism and nutrition disorders | Group A: Single Dose | 14 | 40 | |
| other | Laboratory tumor lysis syndrome | Metabolism and nutrition disorders | Group B: Daily Dose | 11 | 40 | |
| other | Hyperuricemia | Blood and lymphatic system disorders | Group A: Single Dose | 13 | 40 | |
| other | Hyperuricemia | Blood and lymphatic system disorders | Group B: Daily Dose | 11 | 40 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: Single Dose | ||
| Total, all-cause mortality | Group B: Daily Dose | ||
| Total, other adverse events | Group A: Single Dose | 40 | 40 |
| Total, other adverse events | Group B: Daily Dose | 40 | 40 |
| Total, serious adverse events | Group A: Single Dose | 0 | 40 |
| Total, serious adverse events | Group B: Daily Dose | 2 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22015451 | RESULT |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A: Single Dose vs Group B: Daily Dose: Number of Participants With Plasma Uric Acid (UA) Response | Trial comparisons |
| Group A: Single Dose vs Group B: Daily Dose: serious adverse events | Trial comparisons |
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/NCT00628628
GET https://conductscience.org/api/trials/v1/NCT00628628/events?page=2