Trial Information

Chemo-Immunotherapy With Allogeneic Blood Stem Cell Transplantation in Patients With Chronic Lymphocytic Leukemia (Study #02)

Patients with relapsed or refractory CLL who are eligible for the study receive a
cytoreductive therapy until SCT. Irrespective to the formal response, patients proceed to
allogeneic SCT after fludarabine-based reduced-intensity conditioning. The use of
granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood stem cells > 3 x
10E6 CD34 cells/kg is recommended, but bone marrow > 1 x 10E8 MNC/kg is accepted.
GVHD-prophylaxis is based on cyclosporine A adapted to blood levels (150 to 200 ng/mL) over
a period of three months. In Phase I of the study, alemtuzumab has been applied as part of
the conditioning regimen until day 5. In Phase II, alemtuzumab is given as cytoreductive
pre-treatment with the last application of alemtuzumab scheduled for day 14 and after
Amendment II in September 2006 scheduled for day 28. Furthermore methotrexate is given on
days 1, 3, 6. and 11 at a projected cumulative dose of 45 mg/m2. Subsequent
immunosuppressive therapy depends on the occurrence of GvHD, the development of chimerism,
and residual disease. Patients with relapsing or residual disease (minimal residual disease
excluded) who do not suffer from GvHD should receive donor lymphocytes in increasing
dosages. The initial dose is 1 x 105/kg T-cells in unrelated donors and 1 x 106/kg in
matched related donors. If no GvHD develops within 6-8 weeks, the next higher dosage is
applied.