JPRN-jRCTs041210040
Recruiting
Phase 3
A multicenter phase III study in children, adolescent and young adult, and adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia - JPLSG-ALL-B19
Katsuyoshi Koh0 sites2,000 target enrollmentJuly 13, 2021
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Katsuyoshi Koh
- Enrollment
- 2000
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Diagnosis of B cell precursor ALL or pre\-B\-ALL
- •(2\) Consent to FCM and fusion\-gene screening
- •(3\) Age \>\=1 year and \< 65 years old at diagnosis
- •(4\) ECOG performance status (PS) score of 0\-2\. However, PS scores up to 3 are permitted when the deterioration of PS is thought to be due to leukemia.
- •(5\) Sufficient organ function satisfying the laboratory data listed below;
- •\-Direct bilirubin \<\=2\.0 mg/dL or within 3x of age\-adjusted upper\-limit of normal range if the patient is under 16\-year\-old
- •\-Creatinine \<\=2\.0 mg/dL or within 3x of age\-adjusted upper\-limit of normal range if the patient is under 16\-year\-old
- •\-Normal ECG and UCG
- •\-SpO2 \>\= 94% in room air
- •(6\) Written informed consent obtained from patient or guardians.
Exclusion Criteria
- •(1\)BCR\-ABL1 positive ALL
- •(2\)Down syndrome
- •(3\)Malignant hypertension
- •(4\)Pulmonary fibrosis
- •(5\)Interstitial pneumonia
- •(6\)Liver cirrhosis
- •(7\)Positive anti\-HIV antibody or HBs antigen
- •(8\)Uncontrolled diabetes
- •(9\)Uncontrolled infection
- •(10\)Deep thrombosis requiring treatment.
Outcomes
Primary Outcomes
Not specified
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