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BMT<br />

Hehimann et ai. 117<br />

Diagnosis / Relapse<br />

10 12<br />

Partial remission M<br />

Healthy<br />

subjects<br />

1 3<br />

Hochhaus Cross Biernaux et al., 1995<br />

et al., 1996 11<br />

et al., 1993 12<br />

Bose et al., 1998 14<br />

Conventional<br />

RT-PCR positive<br />

'Optimized'<br />

RT-PCR positive<br />

RT-PCR negative 1<br />

Figure 2. Detection of BCR-ABL transcripts by RT-PCR in cytogenetic IFN responders,<br />

successfully transplanted patients <strong>and</strong> healthy subjects. The different detection level<br />

shown in relation to the sensitivity of the assays.<br />

treatment approaches with <strong>and</strong> without subsequent autografting <strong>and</strong> prospective<br />

comparison with allogeneic BMT.<br />

The German CML Study Group started r<strong>and</strong>omized trials in 1983 <strong>and</strong> to date<br />

has recruited more than 1850 CML patients for three consecutive r<strong>and</strong>omized<br />

studies. The first study, CML Study I, recruited patients from 1983 to 1991 <strong>and</strong><br />

compared survival after IFN, HU, <strong>and</strong> busulfan in a three-arm r<strong>and</strong>omized trial.<br />

The results have been published <strong>and</strong> show that IFN <strong>and</strong> HU were both superior to<br />

busulfan, but that IFN was superior to HU only for low-risk patients. 13<br />

' 9<br />

second study (CML Study II) recruited patients from 1991 to 1994 <strong>and</strong> compares<br />

the effects on survival of the combination of IFN <strong>and</strong> HU vs. HU monotherapy. 19<br />

The study is up for final evaluation in 1999. In 1995, the third study (CML Study<br />

III) was started which analyzes the following:<br />

1. the long-term impact of allogeneic bone <strong>marrow</strong> <strong>transplantation</strong> vs. the<br />

best available drug treatment on survival <strong>and</strong><br />

2. the survival outcome after intensification of treatment with idarubicin<br />

<strong>and</strong> intermediate-dose Ara-C vs. IFN/HU/low-dose Ara-C st<strong>and</strong>ard<br />

therapy.<br />

PATIENTS AND METHODS<br />

Seven hundred fifty patients are to be recruited within 6 years.<br />

0<br />

The

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