Risk Stratified Sequential Treatment for CD20-positive PTLD

PHASE2CompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

December 31, 2014

Study Completion Date

July 31, 2015

Conditions
PTLDPosttransplant Lymphoproliferative Disorder
Interventions
DRUG

rituximab monotherapy

375 mg/m2, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between course 4 and 5 the patients directly enter R-CHOP chemotherapy (Arm B).

DRUG

sequential R-CHOP

"375 mg/m2 rituximab, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. Cyclophosphamid 750 mg/m2, adriamycine 50 mg/m2 and vincristine 1.4mg/m2, IV and prednisone 50mg/m2, PO every 3 weeks at days 50, 72, 94 and 116.~In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between antibody and R-CHOP administration the patients directly enter R-CHOP chemotherapy."

Trial Locations (7)

10128

Div. Universitaria Ematologia e Terapie Cellulari, University of Torino, Torino

13353

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

41345

Sahlgrens hospital, Department of Hematology, Gothenburg

75651

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

81519

Zakład Propedeutyki Onkologii, Gdańskiego Uniwersytetu Medycznego, Gdynia

Unknown

Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102, Brisbane

Catholic University of Leuven, Department of Hematology, Leuven

All Listed Sponsors
lead

Charite University, Berlin, Germany

OTHER

NCT00590447 - Risk Stratified Sequential Treatment for CD20-positive PTLD | Biotech Hunter | Biotech Hunter