Leukemia, Myelomonocytic, Chronic Clinical Trial
Official title:
A Phase I/II, Open-Label, Multicenter Study of the Safety, Efficacy and Immune Response of Histamine Dihydrochloride and Low-dose Interleukin-2 in Chronic Myelomonocytic Leukemia (CMML)
Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2
(Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6
week rest periods.
All subjects will be assigned to one of three consecutive cohorts, each comprising five
patients.
Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the
assessment of short-term impact of HDC alone on clonal and immunological markers. For all
remaining cycles the combination of HDC and IL-2 will be given.
Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all
patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical
response and toxicity will be evaluated. On the basis of the results for the first 4 cycles
of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the
combination of HDC/IL-2 or HDC alone.
In case of a beneficial response* after 4 cycles, treatment may be continued to a total of 10
cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during
treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or a
family member/significant other will be instructed to administer injections of both study
drugs to allow safe treatment at home.
n/a
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