JRCT ID: jRCT1051240144
Registered date:02/10/2024
Study of rasburicase administered as needed to prevent the development of tumor lysis syndrome
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Tumor lysis syndrome, Malignant lymphoma, Acute lymphoblastic leukemia |
Date of first enrollment | 02/10/2024 |
Target sample size | 50 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Administer rasburicase as needed |
Outcome(s)
Primary Outcome | Laboratory TLS (LTLS) by 7 days after the start of chemotherapy |
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Secondary Outcome | Clinical TLS by 7 days after chemotherapy Number of additional doses of rasburicase Percentage of uric acid levels kept within normal range by 7 days after chemotherapy Incidence of hyperkalemia, hyperphosphatemia and hyperuricemia by 7 days after chemotherapy TLS incidence in the PSL pretreatment group Risk factors for additional rasburicase administration TLS incidence rate by disease TLS incidence rate by TLS risk Adverse events during the study period |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1.At least 18 years old and able to provide written informed consent 2.Untreated malignant lymphoma or acute lymphoblastic leukemia who are scheduled to receive one of the following chemotherapies (R-)CHOP, Pola-RCHP, DA-EPOCH(-R), DeVIC, (R-)hyperCVAD/MA, ALL prephase, PSL+Dasatinib, GB, RB, A+CHP, VR-CAP, SMILE 3.TLS intermediate or high risk 4.ECOG PS0-2 |
Exclude criteria | 1.LTLS or CTLS prior to chemotherapy 2.eGFR=<30 mL/min/1.73m2 3.Intolerance of adequate hydration due to cardiac dysfunction or fluid retention 4.Patients not expected to survive longer than 3 months 5.Patients previously treated with rasburicase 6.Pregnant patients or breastfeeding patients 7.Patients with known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency 8.Patients who are deemed to be inappropriate to participate by physician a:Definition of LTLS Abnormality of 2 or more of the following: UA >=8.0 mg/dL, K >= 6.0 mEq/dL, P >= 4.5 mg/dL Definition of CTLS In addition to LTLS, one or more of the following: Decreased renal function (serum creatinine >=1.5 x upper reference limit), arrhythmia or sudden death, seizures b:Measurement of G6PD prior to rasburicase administration is not required. Exclude only those who are known by medical interview |
Related Information
Primary Sponsor | Minami Hironobu |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Sakuya Matsumoto |
Address | 7-5-2 Kusunokicho Chuo-ku, Kobe-shi, Hyogo-ken Hyogo Japan 650-0017 |
Telephone | +81-78-382-5111 |
samatsu@med.kobe-u.ac.jp | |
Affiliation | Kobe University Hospital |
Scientific contact | |
Name | Hironobu Minami |
Address | 7-5-2 Kusunokicho Chuo-ku, Kobe-shi, Hyogo-ken Hyogo Japan 650-0017 |
Telephone | +81-78-382-5111 |
hminami@med.kobe-u.ac.jp | |
Affiliation | Kobe University Hospital |