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

Phase 2

Terminated

• Conditions: Post-transplantation Lymphoproliferative Disorder

• Registration Number: NCT01458548
• Lead Sponsor: Charite University, Berlin, Germany

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2008-05
• Status Verified: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-24
• Last Update Submitted: 2011-10-24
• Study First Posted: 2011-10-25
• Last Update Posted: 2011-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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 )

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1; 🇩🇪 Berlin, Germany

Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital; 🇫🇷 Paris, France

Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102; 🇦🇺 Brisbane, Australia

Sahlgrens hospital, Department of Hematology; 🇸🇪 Göteborg, Sweden