A phase II trial for T-cell ALL

JRCT ID: jRCTs041210054

Registered date:17/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: T-cell acute lymphoblastic leukemia
• Date of first enrollment: 23/08/2021
• Target sample size: 259
• Study type: Interventional
• Intervention(s): 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 grade of CNS involvement at diagnosis. Each group receive following treatments; SR group: chemotherapy, HR group: intensified chemotherapy, VHR group: intensified chemotherapy and stem cell transplantation.

Outcome(s)

• Primary Outcome: Three year event free survival

Secondary Outcome

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 drugs
Tolerability of the treatment regimens for each age-defined subgroup (patients younger, or equal or older than 25 years)
Incidence of adverse events 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.
Incidence of thrombosis by supportive therapy and congenital thrombophilia
Estimation of quality of life (QOL) by Questionnaire survey to patients and families
Evaluation of the outcomes before and after incorporating Erw-ASP.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 65age old
• Gender: Both

Include criteria

(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.

Exclude 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

Related Information

• Primary Sponsor: Sato Atsushi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development