Risk Stratified Sequential Treatment for CD20-positive PTLD

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase-II trial will investigate the efficacy, safety and the tolerability of a sequential therapy consisting of 4 courses of single agent rituximab followed by 4 courses of R-CHOP chemotherapy in patients with CD20+ posttransplant lymphoproliferative disorders (PTLD). However, responders to rituximab achieving a CR after the first 4 applications of rituximab will go on with rituximab monotherapy and will not receive chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Antibodies; Rituximab

Criteria

Inclusion Criteria:

• PTLD with or without EBV association, confirmed after biopsy or resection of tumor

• Measurable disease of > 2 cm in diameter and/or bone marrow involvement

• Patients having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or other or a combination of the organ transplantations mentioned

• Karnofsky scale >50% or ECOG ≤ 3

• Reduction of immunosuppression with or without antiviral therapy

• A complete surgical extirpation of tumor was not performed

• A radiation therapy was not performed

• Effective contraception for women in childbearing age

• Patient's written informed consent and written consent for data collection

• Patients are > 18 years (or ≥ 15 years with parental agreement )

Exclusion Criteria:

• Life expectancy less than 6 weeks

• Karnofsky-scale <50% or ECOG ≥ 3

• Treatment with rituximab before

• Known allergic reactions against foreign proteins

• Concomitant diseases, which exclude the administration of therapy as outlined by the study protocol

• non-compensated heart failure

• Dilatative cardiomyopathy

• Myocardial infarction during the last 6 months

• Severe non-compensated hypertension

• Severe non-compensated diabetes mellitus

• Renal insufficiency (creatinine more than 3-fold of the upper normal value), not related to lymphoma

• Hepatic insufficiency with transaminase values greater than 3-fold of the normal values and/or bilirubin levels >3.0 mg/dl, not related to lymphoma

• Clinical signs of cerebral dysfunction

• Women during the lactation period, pregnant or of childbearing potential not using a reliable contraceptive method

• Involvement of the central nervous system by the disease

• Severe psychiatric disease

• Known to be HIV positive

• Missing written informed consent of the patient