8. Patients with CNS involvement will receive 5 spinal taps with 
methotrexate (see Section IV.C.2.) after hematopoietic recovery. 
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 protcxx)!). Such studies should limit the amount of blood 
removed to 20-40 ml. 
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. 
3. Patients will be evaluated annually for the next 10 years by complete 
physical examination and complete blood counts. 
4. Patients will be asked to return thereafter at any time if they develop 
any hematologic^mmunologic abnormality. 
15.0 RESPONSE CRITERIA 
16.0 OFF STUDY CRITERIA 
1. Relapse of AML that required retreatment 
2. Death from transplant related causes 
17.0 RECORDS TO BE KEPT 
All required clinical evaluation records will be the responsibility of Dr. Mirro. 
Analysis of the clinical outcome and toxicity will also be the responsibility of Dr. 
Mirro (see Section 13.0). 
The laboratory evaluation of retroviral insertion will be the responsibility of Drs. 
Brenner and Ihle. 
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Recombinant DNA Research, Volume 14 
