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

JRCT ID: jRCTs071220071

Registered date:24/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acute lymphoblastic leukemia
• Date of first enrollment: 06/01/2023
• Target sample size: 210
• Study type: Interventional

Intervention(s)

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 transplantation will be performed in the MRD-positive group at the end of the second course of consolidation therapy, and transplant adaptation will be established according to risk.
In Ph ALL, the MRD-negative group after dasatinib (DAS) + prednisolone induction therapy will continue to receive DAS combination chemotherapy, and the MRD-positive group will continue to receive ponatinib (PON) combination chemotherapy. Furthermore, after that, by using Blina as a countermeasure against TKI-resistant clones including PON such as compound mutations including T315I, MRD-negative conversion before allogeneic transplantation was attempted, and then allogeneic hematopoietic stem cell transplantation was performed as a radical treatment. , to improve the overall prognosis of Ph ALL. In addition to DAS and PON, we aim to establish Ph ALL treatment using Blina.

Outcome(s)

• Primary Outcome: 3-year disease-free survival rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Koichi Akashi