Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT01564277|
Recruitment Status : Terminated (low accrual)
First Posted : March 27, 2012
Results First Posted : December 8, 2017
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: rasburicase Drug: allopurinol||Phase 2|
I. To prospectively evaluate the efficacy, as defined by uric acid response rate, of 2 different single low doses of rasburicase followed by allopurinol in 2 treatment arms.
I. To estimate the proportion of patients requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL on day 2 through day 6.
II. To identify differential characteristics of the patients who do not respond to treatment.
III. To measure the area under the plasma uric acid concentration-time curve (AUC) from baseline (day 1) to day 7, time to plasma uric acid level less than or equal to 7.5mg/dL.
IV. To evaluate the rate of patients requiring hemodialysis (HD) V. To evaluate the safety of low single-doses of rasburicase. VI. To evaluate the rate of patients expressing a doubling of serum creatinine.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive 1.5mg of rasburicase intravenously (IV) over 30 minutes on day 1* and allopurinol orally (PO) once daily (QD) on days 1-6.
ARM II: Patients receive 3 mg of rasburicase IV over 30 minutes on day 1* and allopurinol PO QD on days 1-6.
NOTE: *Patients with serum uric acid >= 7.5mg/dl also receive rasburicase IV on days 2-3.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy|
|Actual Study Start Date :||September 29, 2011|
|Actual Primary Completion Date :||May 28, 2015|
|Actual Study Completion Date :||May 28, 2016|
Experimental: Arm I (1.5mg rasburicase)
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
Experimental: Arm II (3 mg rasburicase)
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
- Probability of Obtaining a Uric Acid Level =< 7.5mg/dL [ Time Frame: 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.
- Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL [ Time Frame: Up to day 7 ]Count of partcicpants requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL by treatment arm.
- Baseline White Blood Cell Count by Response [ Time Frame: 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).
- Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7 [ Time Frame: Up to day 7 ]The mean area under the plasma uric acid concentration-time curve (AUC) from baseline (Day 1) to Day 7
- Safety of Low Single-doses of Rasburicase. [ Time Frame: up to day 7 ]The number of patients with any adverse events .
- Number of Patients Experiencing a Doubling of Serum Creatinine [ Time Frame: up to day 6 ]Count of participants experiencing a doubling of serum creatinine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564277
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Eunice Wang, MD||Roswell Park Cancer Institute|