Prospective study of Rituximab for chronic graft vs host disease (GVHD) sub-optimally responsive to immunosuppressive therapy: Assessment of response.

Inclusion Criteria1

• Severe chronic Graft Versus Host Disease (cGVHD) diagnosed according to the NIH staging proposal irrespective of the site affected, e.g. (but not restricted to): cutaneous/subcutaneous, hepatic, renal, pulmonary, conjunctival, oral, vaginal, musculoskeletal or haematological cGVHD. 2. Severe cGVHD meeting any of the following 3 criteria:a) failing response during therapy of 2 weeks of greater than or equal to 1 mg/kg prednisolone per day or relapse of symptoms when tapering prednisolone to doses of greater than or equal to 0.5 mg/kg b) suboptimal response to a minimum of two months of at least two immunosuppressants c) clinically significant relapse of cGVHD within 3 months of cessation of immunosuppression for the initial episode of cGVHD OR second relapse (with all three episodes occurring within 18 months). 3. Patients with long-standing cGVHD (defined as >6 months of accumulated intensive therapy, as defined above under 1. and 2.) are only eligible if there is unequivocal biopsy proof of ongoing active inflammation (e.g. lymphocytic infiltrate with cellular damage) in the relevant organ e.g. skin. 4. ECOG performance status < grade 2 and life expectancy > 3 months. 5. Signed written informed consent to participate in the study.