6 . 
Normal peripheral counts (WBC >3000/mm 3 , platelet counts > 150,000/mm 3 ). 
B. Exclusion criteria 
1. Patients ineligible for autologous marrow transplantation. 
2. Patients who are HTV+. . 
3. Patients with active infections. 
4. Patients with histologic evidence of circulating malignant cells. 
5. Patients with AML or CML. 
6. Patients who receive chemical purged marrow. 
7. Patients who are unable to undergo pheresis for any reasons (refer to guidelines 
for granulocyte donors). 
8. Patients with rapidly progressive disease requiring immediate therapy. 
6. Informed Consent 
The principal investigator or one of his associates must explain verbally and in writing the 
nature of the study and the action of rhG-CSF in such a manner that each patient or legal guardian of 
each patient is aware of the potential risks. The patient (or legal guardian) must also be informed that 
he/she (or the patient) may withdraw from the study at any time and for whatever reason, without 
prejudice to their future treatment. If a legal guardian signs the informed consent, in accordance with 
Federal Regulations, he/she must sign the IRB-approved informed consent form in the presence of a 
witjiess... 
7. Study Synopsis 
This study is designed to .show a decrease in the days to an ANC of 100 and a decrease in the 
time to 20,000 platelets by 5 days. A total of 20 patients will be treated on this protocol. Bone marrow 
/ill be harvested and stored prior to the initiation of G-CSF. Seven daily doses of G-CSF will be 
administered by subcutaneous injection in the Outpatient Department. Daily analysis of CD34 + cells 
will be performed and periodic samples will be obtained for cell culture (CFU-GM) to define the 
optimal times for peripheral blood harvesting in future studies. As a starting point, just before the fifth 
dose of G-CSF, peripheral blood nucleated cells will be harvested by pheresis daily for 4 days and 
cryopreserved. Peripheral blood cells will be collected approximately 20 hours after the last dose of G- 
CSF just prior to the next dose of G-CSF. Patients will receive the preparative regimen as specified 
per the FHCRC protocol specific to the patient’s disease and phase. Following the treatment regimen 
cryopreserved bone marrow cells will be administered. Following this the G-CSF stimulated peripheral 
blood nucleated cells will be infused. Within 2 hours of completing the infusion of-the peripheral blood 
cells the first dose of rhG-CSF will be given (16 /ig/kg/day). RhG-CSF administration will continue 
through day 20. 
8. Study Design 
Peripheral blood cells will be administered to patients undergoing ABMT followed by rhG-CSF. 
G-CSF will be administered to 20 eligible patients (see Section 7) at a dose of 16 /tg/kg/day 
subcutaneously for 7 daily doses. Stimulated peripheral blood cells will be administered within 24 hours 
following infusion of unstimulated bone marrow cells. All organ systems will be checked by daily 
clinical assessment and laboratory/radiologic tests. From the 28th day or from hospital discharge until 
100 days post-transplantation the patients will have follow-up monitoring on a weekly basis. 
Recombinant DNA Research, Volume 16 
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