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Treatment protocol for adult acute lymphoblastic leukemia -ALL/MRD2025- (JSCT ALL/MRD2025)

Treatment protocol for adult acute lymphoblastic leukemia -ALL/MRD2025- (JSCT ALL/MRD2025)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071250059
Enrollment
250
Registered
2025-08-07
Start date
2025-09-01
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 non-Ph ALL, blinatumomab (Blina) will be used upfront to achieve and maintain MRD negativity. In CD19-negative non-Ph ALL, patients who remain MRD-positive after the second consolidat

Sponsors

Koichi Akashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with acute lymphoblastic leukemia (ALL) according to the WHO classification (5th edition) with >=25% blasts in the bone marrow, or patients diagnosed with mixed phenotype acute leukemia (MPAL) according to the WHO classification (5th edition) with >=25% blasts in the bone marrow and receiving ALL-directed chemotherapy. 2.Newly diagnosed patients who have not received chemotherapy or radiotherapy. The use of hydroxyurea or leukapheresis for tumor burden control before the start of the prephase treatment is permitted. 3.Patients aged between 16 and 70 years at the time of diagnosis. 4.Patients with an ECOG Performance Status of 0 to 2. 5.Patients without severe organ dysfunction. Total bilirubin =<2.0 mg/dL, creatinine=<2.0 mg/dL. 6.Patients who have provided written informed consent after receiving an explanation of the study.

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

Countries

Japan, none

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