A phase III randomized trial for B-cell precursor A
- Conditions
- B cell precursor Acute Lymphoblastic LeukemiaPrecursor B-Cell Lymphoblastic Leukemia-Lymphoma
- Registration Number
- JPRN-jRCTs041210040
- Lead Sponsor
- Katsuyoshi Koh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2000
(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.
(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.
(11)Mental disorder that will likely make it impossible to complete treatment according to the protocol
(12)Active double cancer
(13)Pregnant or lactating woman, or high possibility of pregnancy
(14)Past History of congenital or acquired immunodeficiency
(15)Any inappropriate status judged by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method