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

Charité University Medicine Berlin

Status and phase

Terminated

Phase 2

Conditions

Post-transplantation Lymphoproliferative Disorder

Treatments

Drug: Rituximab

Drug: CHOP

Study type

Interventional

Funder types

Other

Identifiers

NCT01458548

PTLD-1

Details and patient eligibility

About

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).

Enrollment

70 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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