Trial · NCT01564277

Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies

NCT01564277, Phase 2, Terminated, Roswell Park Cancer Institute; results first posted 2017-12-08

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies. Trials, record NCT01564277. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01564277

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
NCT number: NCT01564277
Status: Terminated
Phases: Phase 2
Enrollment: 24 participants, actual
Lead sponsor: Roswell Park Cancer Institute
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Burkitt Lymphoma, de Novo Myelodysplastic Syndromes, Noncontiguous Stage II Adult Burkitt Lymphoma, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Stage I Adult Burkitt Lymphoma, Stage III Adult Burkitt Lymphoma, Stage IV Adult Burkitt Lymphoma, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia
Interventions: rasburicase, allopurinol
First posted: 2012-03-27
Last updated: 2018-01-09
Results first posted: 2017-12-08

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Probability of Obtaining a Uric Acid Level =< 7.5mg/dL	Within 24 hours of rasburicase treatment	The proportion of patients able to achieve and/or maintain a uric acid level =\< 7.5mg/dL for each treatment arm.
Secondary	Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL	Up to day 7	Count of partcicpants requiring additional doses of rasburicase to maintain a uric acid level =\< 7.5mg/dL by treatment arm.
Secondary	Baseline White Blood Cell Count by Response	Up to day 7	The mean baseline white blood cell count of patients with a complete response (CR) (patients who achieved uric acid level =\< 7.5mg/dL) and no CR (patients with uric acid level \> 7.5mg/dL).
Secondary	Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7	Up to day 7	The mean area under the plasma uric acid concentration-time curve (AUC) from baseline (Day 1) to Day 7
Secondary	Safety of Low Single-doses of Rasburicase.	up to day 7	The number of patients with any adverse events .
Secondary	Number of Patients Experiencing a Doubling of Serum Creatinine	up to day 6	Count of participants experiencing a doubling of serum creatinine

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Probability of Obtaining a Uric Acid Level =< 7.5mg/dL	Within 24 hours of rasburicase treatment	All treated and eligible patients	proportion of participants	NUMBER
SECONDARY	Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL	Up to day 7	All treated and eligible patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Baseline White Blood Cell Count by Response	Up to day 7	All treated and eligible patients	cells x 10^9/L	MEAN
SECONDARY	Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7	Up to day 7	All treated and eligible patients	days*mg/dL	MEAN
SECONDARY	Safety of Low Single-doses of Rasburicase.	up to day 7	All treated and eligible patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients Experiencing a Doubling of Serum Creatinine	up to day 6	All treated and eligible patients	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Probability of Obtaining a Uric Acid Level =< 7.5mg/dL	Arm I (1.5mg Rasburicase)		0.83	95% Confidence Interval 0.52 to 0.98	proportion of participants
Probability of Obtaining a Uric Acid Level =< 7.5mg/dL	Arm II (3 mg Rasburicase)		0.67	95% Confidence Interval 0.35 to 0.90	proportion of participants
Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL	Arm I (1.5mg Rasburicase)		1		Participants
Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL	Arm II (3 mg Rasburicase)		3		Participants
Baseline White Blood Cell Count by Response	Arm I (1.5mg Rasburicase)	Complete Response	62.1	Standard Deviation 32.3	cells x 10^9/L
Baseline White Blood Cell Count by Response	Arm II (3 mg Rasburicase)	Complete Response	29.0	Standard Deviation 34.0	cells x 10^9/L
Baseline White Blood Cell Count by Response	Arm I (1.5mg Rasburicase)	No Complete Response	13.9	Standard Deviation 17.1	cells x 10^9/L
Baseline White Blood Cell Count by Response	Arm II (3 mg Rasburicase)	No Complete Response	33.3	Standard Deviation 19.0	cells x 10^9/L
Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7	Arm I (1.5mg Rasburicase)		12.5	Standard Deviation 9.0	days*mg/dL
Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7	Arm II (3 mg Rasburicase)		3.5	Standard Deviation 4.7	days*mg/dL

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (1.5mg Rasburicase)	12
Overall Study	STARTED	Arm II (3 mg Rasburicase)	12
Overall Study	COMPLETED	Arm I (1.5mg Rasburicase)	11
Overall Study	COMPLETED	Arm II (3 mg Rasburicase)	11
Overall Study	NOT COMPLETED	Arm I (1.5mg Rasburicase)	1
Overall Study	NOT COMPLETED	Arm II (3 mg Rasburicase)	1

Source ClinicalTrials.gov

Adverse events238

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	Anaemia	Blood and lymphatic system disorders	Arm I (1.5mg Rasburicase)	6	12	38
other	Anaemia	Blood and lymphatic system disorders	Arm II (3 mg Rasburicase)	4	12	10
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Arm I (1.5mg Rasburicase)	0	12	0
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Arm II (3 mg Rasburicase)	1	12	2
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm I (1.5mg Rasburicase)	4	12	8
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm II (3 mg Rasburicase)	2	12	8
other	Leukopenia	Blood and lymphatic system disorders	Arm I (1.5mg Rasburicase)	7	12	44
other	Leukopenia	Blood and lymphatic system disorders	Arm II (3 mg Rasburicase)	4	12	14
other	Lymphopenia	Blood and lymphatic system disorders	Arm I (1.5mg Rasburicase)	0	12	0
other	Lymphopenia	Blood and lymphatic system disorders	Arm II (3 mg Rasburicase)	1	12	2

1 to 10 of 238Source ClinicalTrials.gov

See all 238 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (1.5mg Rasburicase)
Total, all-cause mortality	Arm II (3 mg Rasburicase)
Total, other adverse events	Arm I (1.5mg Rasburicase)	12	12
Total, other adverse events	Arm II (3 mg Rasburicase)	11	12
Total, serious adverse events	Arm I (1.5mg Rasburicase)	0	12
Total, serious adverse events	Arm II (3 mg Rasburicase)	1	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA016056	Roswell Park Cancer Center Support Grant	JOHNSON, CANDACE S	ROSWELL PARK CANCER INSTITUTE CORP	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I (1.5mg Rasburicase) vs Arm II (3 mg Rasburicase): Safety of Low Single-doses of Rasburicase.	Trial comparisons
Arm I (1.5mg Rasburicase) vs Arm II (3 mg Rasburicase): Number of Patients Experiencing a Doubling of Serum Creatinine	Trial comparisons
Arm I (1.5mg Rasburicase) vs Arm II (3 mg Rasburicase): Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL	Trial comparisons
Arm I (1.5mg Rasburicase) vs Arm II (3 mg Rasburicase): 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.

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/NCT01564277

GET https://conductscience.org/api/trials/v1/NCT01564277/events?page=2

API reference For AI assistants