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Treatment protocol for adult acute lymphoblastic leukemia (-ALL/MRD2023-)

Phase 2
Recruiting
Conditions
acute lymphoblastic leukemia
Registration Number
JPRN-jRCTs071220071
Lead Sponsor
Koichi Akashi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
210
Inclusion Criteria

1.Cases diagnosed with acute lymphocytic leukemia in the WHO classification (2017) with more than 26% blasts in the bone marrow, or mixed phenotype acute leukemia (MPAL) in the WHO classification (2017). Patients with more than 26% blasts in the bone marrow and undergoing ALL-directed chemotherapy. The WHO classification (2017 edition) is used as the diagnostic criteria for MPAL in this study.
3.First-time treatment patients who have not received chemotherapy or radiotherapy.
3.Patients aged between 16 and 65 years old.
4.Performance status (ECOG): 0 to 2 cases.
5.Cases without severe organ damage. T. Bil=<2.0mg/dL, Cr=<2.0mg/dL
6.Patients who have given written consent from the patient after explaining the content of this research. However, in the case of minors, written consent has been obtained from the legal representative and the individual.

Exclusion Criteria

1. Blast cell surface immunoglobulin-positive Burkitt leukemia.
2.Patients with active double cancer.
3.Patients with difficult-to-control infections.
4. Cases with severe mental disorders.
5. Pregnant cases.
6.Other cases judged inappropriate by the attending physician.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
3-year disease-free survival rate
Secondary Outcome Measures
NameTimeMethod
3-year/5-year overall survival rate, 5-year disease-free survival rate, 3-year/5-year complete remission rate, remission rate (CR, MRDneg), protocol completion rate, treatment-related death (TRM) rate, adverse event rate
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