Treatment protocol for adult acute lymphoblastic leukemia

JRCT ID: jRCTs071190036

Registered date:18/11/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: acute lymphoblastic leukemia
• Date of first enrollment: 07/01/2020
• Target sample size: 200
• Study type: Interventional

Intervention(s)

In adult BCR/ABL negative ALL, the indication of allogeneic HSCT will be determined by the MRD status. High-risk patients will proceed to allogeneic HSCT. Low-risk patients will proceed to maintenance treatment which is less toxic than HSCT. (nonPh ALL/MRD2019 protocol)

In adult BCR/ABL positive ALL, patients will receive induction therapy combined with dasatinib or ponatinib. Every patient will proceed to allogeneic HSCT whenever possible. (Ph ALL/MRD2019 protocol)

Outcome(s)

• Primary Outcome: 3 years disease-free survival

Secondary Outcome

3 year, and 5 years overall survival
5 years disease-free survival
3 year, and 5 years CR rate
CR rate,MRDneg rate
Perfection rate of protocol regimen
Treatment related mortality rate
Treatment-related toxicities

Key inclusion & exclusion criteria

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

Include criteria

1. acute lymphoblastic leukemia by WHO classification
2. peroxidase positive rate of the blast cell, 3% are less than it
3. The first time treatment example which does not catch chemotherapy or the radiotherapy
4. The case that is equal to or less than 65 years old more than age 16 years old
5. Performance status 0-2
6. A case without the dangerously ill internal organs disorder
T.Bil equal to or less than 2.0mg/dL, Cr equal to or less than 2.0mg/dL
7. The case that an agreement by the document is provided from a patient on explanation because of final examination contents

Exclude criteria

1. B-ALL(L3) of the blast cell cell surface immune globulin positive
2. A case having double cancers
3. A case with an infectious disease having difficulty with control
4. A case with a severe mental disorder
5. The pregnancy woman
6. the case that the medical attendant judged to be inappropriate

Related Information

• Primary Sponsor: Akashi Koichi
• Source(s) of Monetary Support: The Regional Medicine Research Foundation
• Secondary ID(s): UMIN000037626