Status:
TERMINATED
Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Post-transplantation Lymphoproliferative Disorder
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01458548
Start Date
December 1 2002
End Date
October 1 2011
Last Update
October 25 2011
Active Locations (4)
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1
Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102
Brisbane, Australia
2
Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital
Paris, France, 75651
3
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1
Berlin, Germany, 13353
4
Sahlgrens hospital, Department of Hematology
Gothenburg, Sweden, 41345