A phase II trial for T-cell A
- Conditions
- T-cell acute lymphoblastic leukemiaPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma
- Registration Number
- JPRN-jRCTs041210054
- Lead Sponsor
- Sato Atsushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 259
(1) Diagnosis of T cell ALL
(2) Age < 65 years old at diagnosis
(3) 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.
(4) Sufficient organ function satisfying the laboratory data listed below;
i) Direct bilirubin: = or < 2.0 mg/dL
ii) Creatinine: = or < 2.0 mg/dL
iii) Normal ECG and UCG. Although UCG is not essential, it should be examined when cardiac function may be low. EF = or > 50% when it is examined.
iv) SpO2 = or > 94% in room air
(5) Written informed consent obtained from patient or guardians.
(1) BCR-ABL1 positive ALL
(2) Down syndrome
(3) Intracranial hemorrhage = or > grade 3 in CTCAE v5.0
(4) Malignant hypertension
(5) Pulmonary fibrosis
(6) Interstitial pneumonia
(7) Liver cirrhosis
(8) Positive anti-HIV antibody or HBs antigen
(9) Uncontrolled diabetes
(10) Uncontrolled infection
(11) Deep thrombosis requiring treatment.
(12) Mental disorder that will likely make it impossible to complete treatment according to protocol
(13) Active double cancer
(14) Pregnant or lactating woman, or high possibility of pregnancy
(15) Past History of congenital or acquired immunodeficiency
(16) Any inappropriate status judged by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Three year event free survival
- Secondary Outcome Measures
Name Time Method