T-cell acute lymphoblastic leukemia T-cell acute lymphoblastic leukemia
Conditions
Interventions
Patients are allocated into SR group, HR group, and VHR group based on response to treatment such as PSL response in pre-phase and minimal residual disease after early intensification therapy and grad
SR group: chemotherapy, HR group: intensified chemotherapy, VHR group: intensified chemotherapy and stem cell transplantation.
Sponsors
Koh Katsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Diagnosis of T cell ALL (2) Age 50% when it is examined. iv) SpO2 = or > 94% in room air (5) Written informed consent obtained from patient or guardians.
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three year event free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Three-year survival, incidence of CNS relapse, cumulative incidence of relapse, cumulative incidence of non-relapse mortality Three-year event free survival, overall survival, cumulative incidence of CNS relapse, cumulative incidence of relapse, and cumulative incidence of non-relapse mortality for each risk group (SR, HR, VHR) Three-year event free survival, overall survival, cumulative incidence of CNS relapse, cumulative incidence of relapse, and cumulative incidence of non-relapse mortality for each age-defined subgroup of younger than 15 years, 15 to 24 years, 25 to 39 years, 40 to 59 years, and 60 to 64 years. Remission rate after induction chemotherapy and early intensification chemotherapy Incidence of silent inactivation of L-asparaginase and Three-year event free survival, overall survival, cumulative incidence of CNS relapse, cumulative incidence of relapse, and cumulative incidence of non-relapse mortality for patients with silent inactivation of L-asparaginase. Rates of patients with PCR-MRD available or patients who were evaluated with FCM-MRD, results of PCR-MRD and FCM-MRD, and three-year event free survival, overall survival, cumulative incidence of CNS relapse, cumulative incidence of relapse, and cumulative incidence of non-relapse mortality for groups defined by MRD status at time point 2 (PCR-MRD or FCM-MRD) Three-year event free survival, overall survival, cumulative incidence of CNS relapse, cumulative incidence of relapse, and cumulative incidence of non-relapse mortality for patients with Early T-cell Precursor ALL Three-year event free survival, overall survival, cumulative incidence of CNS relapse, cumulative incidence of relapse, and cumulative incidence of non-relapse mortality for patients with SPI1-fusion transcripts, and correlation of the presence of SPI1-fusion transcripts and MRD results. Incidence of adverse events. Incidence of deep mycosis by treatment phase and age subgroups Incidence of deep mycosis by prophylactic antifungal | — |
Contacts
Public ContactAtsushi Sato
MIYAGI CHILDREN'S HOSPITAL
Outcome results
None listed