Post-transplantation Lymphoproliferative Disorder Clinical Trial
Official title:
Treatment of Patients With Posttransplant Lymphoproliferative Disorder (PTLD) With a Sequential Treatment Consisting of Anti-CD20 Antibody Rituximab and CHOP+GCSF Chemotherapy (Including 1st+2nd Amendment)
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).
| Status | Terminated |
| Enrollment | 70 |
| Est. completion date | October 2011 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102 | Brisbane | |
| France | Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital | Paris | |
| Germany | Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1 | Berlin | |
| Sweden | Sahlgrens hospital, Department of Hematology | Göteborg |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany |
Australia, France, Germany, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of patients with complete and partial remission | 1 month (plus or minus 7 days) after the last cycle of chemotherapy | No | |
| Primary | response duration | from date of best response until the date of first documented progression, assessed up to 3 years | No | |
| Secondary | number of patients with treatment-related death | from start of treatment, assessed up to 12 months after the end of treatment | Yes | |
| Secondary | overall survival | from start of treatment until date of death from any cause, assessed up to 3 years | Yes |