Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)
Study Details
Study Description
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 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- number of patients with complete and partial remission [1 month (plus or minus 7 days) after the last cycle of chemotherapy]
- response duration [from date of best response until the date of first documented progression, assessed up to 3 years]
Secondary Outcome Measures
- number of patients with treatment-related death [from start of treatment, assessed up to 12 months after the end of treatment]
- overall survival [from start of treatment until date of death from any cause, assessed up to 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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PTLD with or without EBV association, confirmed after biopsy or resection
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Measurable disease of > 2 cm in diameter and/or bone marrow involvement
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Patients having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or other or a combination of the organ transplantations mentioned
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Karnofsky scale >50% or ECOG ≤ 3
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Reduction of immunosuppression with or without antiviral therapy
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A complete surgical extirpation of tumor was not performed
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A radiation therapy was not performed
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Effective contraception for women in childbearing age
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Patient's written informed consent and written consent for data collection
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Patients are > 18 years (or ≥ 15 years with parental agreement )
Exclusion Criteria:
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Life expectancy less than 6 weeks
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Karnofsky-scale <50% or ECOG =3
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Treatment with rituximab before
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Known allergic reactions against foreign proteins
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Concomitant diseases, which exclude the administration of therapy as outlined by the study protocol
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non-compensated heart failure
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Dilatative cardiomyopathy
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Myocardial infarction during the last 6 months
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Severe non-compensated hypertension
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Severe non-compensated diabetes mellitus
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Renal insufficiency (creatinine more than 3-fold of the upper normal value), not related to lymphoma.
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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
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Clinical signs of cerebral dysfunction
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Women during the lactation period, pregnant or of childbearing potential not using a reliable contraceptive method
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Involvement of the central nervous system by the disease
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Severe psychiatric disease
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Known to be HIV positive
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Missing written informed consent of the patient
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | Göteborg | Sweden | 41345 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Principal Investigator: Ralf U Trappe, MD, Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- PTLD-1