| Research Abstract |
The purpose of this research project is to inprove the cure rate and the QOL of the childhood ALL via a novel strategy of leukemia-therapy which is based on the minimal residual disease in early phase of chemotherapy.
We started the protocol in February 2000. By the end of December 2002, 214 children with ALL have been enroled in the project. All of them were stratified into 4 groups, HHR (high-high-risk, 23 patients), HR (high-risk, 82 patients), IR (intermediate-risk, 48 patients), and LR (low-risk 61 patients), according to the age and white blood counts at diagnosis. In 186 patients (80%), we could find clonal recombination of either TCR gamma (48 patients), TCR delta (44 patients), Ig kappa (43 patients), or heavy chain (32 patients) gene which was suitable for the targets of PCR amplification. We could quantitate the MRD in the bone marrow in 161 patients 4 weeks (point 1) and 12 weeks (point 2) after the initiation of therapy. BM-MRD were positive in point 1, point2, and both points in 67 patients (36%), 36 patients (19.4%), and 34 patients (18.3%), respectively. Positive rates in both points were 18%, 16.4%, 7.3% and 58% in LR, IR, HR, and HHR-group, respectively. 2-years event-free survival (EFS) of the whole patients is 91.4%. It is too early to draw any conclusion concerning the relevance between MRD and prognosis
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