Treatment protocol for adult acute lymphocytic leukemia -ALL/ MRD2008-

UMIN ID: UMIN000001519

Registered date:01/12/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: adult acute lymphocytic leukemia
• Date of first enrollment: 2008/12/01
• Target sample size: 20
• Countries of recruitment: Japan
• 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. In adult BCR/ABL positive ALL, patients will receive induction therapy combined with imatinib. Every patient will proceed to allogeneic HSCT whenever possible.

Outcome(s)

• Primary Outcome: 3 years disease-free survival
• Secondary Outcome: 5 years disease free survival, CR rate, treatment-related toxicities

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 65years-old
• Gender: Male and Female
• 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 or breast-feeding woman 6. the case that the medical attendant judged to be inappropriate

Related Information

• Primary Sponsor: Fukuoka Blood & Marrow Transplant Group
• Source(s) of Monetary Support: Fukuoka Blood & Marrow Transplant Group