Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).

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

Details

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

Criteria

Inclusion Criteria:

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

• 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