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

Phase 2

Withdrawn

Conditions: Chronic graft versus host disease post allogeneic bone marrow transplant
Surgery - Other surgery

Registration Number: ACTRN12606000326594

Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: All

Target Recruitment: 20

Inclusion Criteria

1. 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.

Exclusion Criteria

1. Patients with burnt-out” cGVHD, i.e. long-standing cGVHD who lack an unequivocal biopsy proof of ongoing active inflammation (e.g. lymphocytic infiltrate with cellular damage) in the relevant organ e.g. skin.2. Secondary tumour, other than basal cell carcinoma, after allogeneic transplantation3. Presence of an EBV-associated post transplant lymphoproliferative disease4. Severe uncontrolled infections (note: treated CMV-reactivation, resolved sepsis, responsive fungal infection will not be exclusion criteria)5. Uncontrolled relapse of the original haematological condition for which the transplant was performed6. Pregnancy or breast feeding7. ECOG performance status grade 3 to 4 or expected life expectancy <3 months8. Concurrent or previous therapy with Rituximab (except application before transplantation for control of CD20+ malignancy)9. Hypersensitivity against Rituximab or other human immunoglobulin preparations10. Concurrent participation in another investigative drug trial11. Inability to understand the nature and the extent of the trial and the procedures required.