Post-transplantation Lymphoproliferative Disorder
Conditions
Keywords
1st-line therapy, single agent rituximab, CHOP, PTLD
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).
Interventions
DRUGCHOP
Cyclophosphamide 750 mg/m2 IV, adriamycine 50 mg/m2 IV, vincristine 1.4mg/m2 IV, and prednisone 50mg/m2 PO every 3 weeks at days 50, 72, 94 and 116.
DRUGRituximab
Rituximab 375 mg/m2 IV on days 1, 8, 15 and 22.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia, France, Germany, Sweden
Outcome results
None listed