Chronic Phase CML
PBSC vs. Interferon vs. ALLO BMT
ECOG 7995
Objectives:
1. To examine differences in overall survival comparing autologous peripheral
blood stem cell (PBSC) transplantation vs. interferon therapy vs. allogeneic bone
marrow transplantation.
Eligibility:
INITIAL INCLUSION / EXCLUSION:
Induction Phase
1. New diagnosed chronic phase CML with the following:
* Presence of Ph-1 and/or detection of BCR-ABL by reverse transcription
polymerase chain reaction or monoclonal antibody.
2. Patients must be in first chronic phase, and not be in either accelerated phase or blast crisis.
3. Interval from diagnosis to enrollment on this trial must not exceed 3 months.
No prior chemotherapy / radiation / and >5 hears free of evidence of any preceding cancer surgically resected for cure.
4. >=18 years old and <=61 years old.
5. No major medical problems (cardiac, venal, hepatic, respiratory).
6. Not pregnant or lactating.
7. Karyotype submissions and submission of samples for surface markers is mandatory.
Post-Initial Assessment Therapy
1. Patients who do not have marked initial response to IFN (<=65% Ph-1 negative metaphases in marrow) will be offered ALLO BMT or randomized between PBSCT or IFN. Patients who have a marked response will continue IFN treatment, but may elect to undergo ALLO BMT.
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