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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071220071
Enrollment
210
Registered
2022-11-24
Start date
2023-01-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lymphoblastic leukemia

Interventions

In CD19-positive nonPh ALL, blinatumomab (Blina) is used as an upfront to achieve MRD-negative conversion and maintenance. In CD19-negative nonPh ALL, allogeneic hematopoietic stem cell transplantatio

Sponsors

Koichi Akashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
3-year disease-free survival rate

Secondary

MeasureTime frame
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

Contacts

Public ContactShima Takahiro

Kyushu University Hospital

shima.takahiro.993@m.kyushu-u.ac.jp+81-92-642-5230

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026