13.3 Evaluation after Hematologic Reconstitution. 
1. Weekly for 6 weeks, monthly for 6 months and every 6 months for 2 
years, then annually for 2 years, analysis and separation by FACS of 
peripheral blood nucleated cells with sorting into granulocytes, 
monocytes, T cells and B cells and subsequent analysis for marker gene 
insertion (see protocol). Such studies should limit the amount of blood 
removed to 20-40 ml. Serum will also be frozen and sent for analysis 
for replication competent virus (all samples to BMT lab). 
2. Patients will also undergo complete physical examination, complete 
blood counts, and bone marrow aspiration every 6 months for the first 
2 years and annually thereafter for the next 2 years. Serum will be 
sent for analysis of replication competent virus. 
3. CSF + patients will require a lumbar puncture every 6 months for the 
first 2 years, then annually for 2 years. 
4. Patients will be evaluated annually for the next 10 years by complete 
physical examination and complete blood counts. Serum will be sent 
for analysis of replication competent virus. 
5. Patients will be asked to return thereafter at any time if they develop 
any hematologic/immunologic abnormality or if any malignancy 
develop. Malignant tissues will be examined for proviral (monoclonal) 
insertion. 
14.0 RESPONSE CRITERIA 
All patients will be transplanted in complete remission. Response criteria will be 
measured by event-free and disease-free survival. 
15.0 OFF STUDY CRITERIA 
1 . Relapse of AML that required retreatment 
2. Death from transplant related causes 
3. Inability to clear CSF blasts with IT MTX prior to ABMT. 
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