Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia
The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts
with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to
several differences between adults and children with respect to biological characteristics
of leukemic cells, tolerance to anticancer drugs, treatment itself, and so on. It has been
reported that adolescent ALL patients who were treated according to the pediatric protocol
had a significantly better survival than those who were treated according to the adult
protocol, indicating that the difference of treatment may be of considerable importance. To
test the hypothesis, the Japan Adult Leukemia Study Group (JALSG) has planned a phase 2
study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen
which was used by the Japan Association of Childhood Leukemia Study. Those who are positive
for BCR-ABL can participate in a separate protocol. The regimen is especially characterized
by dose-intensified L-asparaginase, high-dose methotrexate, and intensified maintenance
therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival
3 years
No
Fumihiko Hayakawa, MD
Study Director
Nagoya University Graduate School of Medicine
Japan: Ministry of Health, Labor and Welfare
JALSG ALL202-U
NCT00131053
September 2002
September 2011
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