Risk-stratified Sequential Treatment of Post-transplant Lymphoproliferative Disease (PTLD) With Rituximab SC and Immunochemotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 3, 2015

Primary Completion Date

July 13, 2021

Study Completion Date

July 13, 2022

Conditions
Posttransplant Lymphoproliferative Disorder
Interventions
DRUG

Rituximab sc

All patients will receive 4 courses of rituximab on days 1, 8, 15 and 22. Rituximab will be administered as a single therapeutic agent at a standard dosage of 375 mg/m2 infused intravenously at day 1. Three subsequent single therapeutic agent applications of rituximab will be administered subcutaneously at a fixed dose of 1400 mg once a week for 3 weeks at days 8, 15 and 22.

DRUG

Rituximab sc consolidation

Patients considered low-risk will receive four more single therapeutic agent applications of rituximab administered subcutaneously at a fixed dose of 1400 mg once every three weeks at days 50, 71, 92 and 113.

DRUG

Rituximab sc combined with CHOP chemotherapy

Patients considered high-risk will receive four more applications of rituximab administered subcutaneously at a fixed dose of 1400 mg combined with CHOP chemotherapy every 3 weeks at days 50, 71, 92 and 113. CHOP chemotherapy will be administered at standard doses: cyclophosphamide 750 mg/m2, adriamycine 50 mg/m2, vincristine 1.4mg/m2 (maximum total dose: 2mg) and prednisone 100mg (at day 1 to 5 of each cycle). Cyclophosphamid, adriamycine and vincristine will be infused intravenously. Prednison will be administered orally in a single dose. At day 3-4 of each treatment cycle either a single dose of 6 mg Peg-GCSF or repetitive doses of 5 µg/kg GCSF until recovery of WBC will be applied subcutaneously, as per institutional practice.

DRUG

Rituximab sc combined with alternating chemotherapy with CHOP and DHAOx

Patients considered very high-risk will receive six more applications of rituximab sc at a fixed dose of 1400 mg combined with chemotherapy every 3 weeks. Chemotherapy is CHOP at days 50, 92 and 134 (cyclophosphamide IV 750 mg/m2, adriamycine IV 50 mg/m2, vincristine IV 1.4mg/m2 (maximum total dose: 2mg) and prednisone PO 100mg (at day 1 to 5 of each cycles). Chemotherapy is DHAOx at days 71, 113 and 155 (oxaliplatin (130 mg/m2, day 1) and cytarabine (ARA-C, 2x 1000 mg/m2 at day 2) dexamethasone PO (40 mg/m2, day 1)), as per institutional practice. At day 3-4 of each treatment cycle either a single dose of 6 mg Peg-GCSF or repetitive doses of 5 µg/kg GCSF until recovery of WBC will be applied subcutaneously, as per institutional practice.

Trial Locations (18)

10117

Charite Universitätsmedizin Berlin Campus Mitte, Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Berlin

Charité - Universitätsmedizin Berlin CCM Medizinische Klinik m. S. Nephrologie, Berlin

18057

Universitätsmedizin Rostock Klinik für Innere Medizin III Hämatologie, Onkologie, Palliativmedizin, Rostock

24105

II. Medizinische Klinik, Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel

24939

Malteser Krankenhaus St. Franziskus-Hospital Med. Klinik 1, Flensburg

26133

Klinikum Oldenburg gGmbH Klinik für Innere Medizin II, Oldenburg

28239

DIAKO Bremen gGmbH, Klinik für Hämatologie und Onkologie, Bremen

30625

Medizinische Hochschule Hannover Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Hanover

35385

Universitätsklinikum Gießen Med. Klinik IV, Giessen

45147

Universitätsklinikum Essen Klinik für Hämatologie, Essen

52074

Uniklinik RWTH Aaachen Klinik für Onkologie, Hämatologie und Stammzell-transplantation Med. Klinik IV, Aachen

53105

Universitätsklinikum Bonn Med. Klinik III/ZIM Hämatologie/Onkologie, Bonn

55101

Universitätsmedizin der Johannes-Gutenberg-Universität III. Medizinische Klinik, Mainz

60590

Universitätsklinikum Frankfurt Med. Klinik III, Nephrologie, Frankfurt am Main

70174

Klinikum Stuttgart Klinik für Hämatologie und int. Onkologie, Stuttgart

81377

Klinikum der Universität München-Großhadern Med. Klinik III, München

91054

Universitätsklinikum Erlangen Med. Klinik 5 Hämatologie und Intern. Onkologie, Erlangen

94032

Klinikum Passau II. Med. Klinik, Passau

All Listed Sponsors
lead

Diako Ev. Diakonie-Krankenhaus gemeinnützige GmbH

OTHER

NCT02042391 - Risk-stratified Sequential Treatment of Post-transplant Lymphoproliferative Disease (PTLD) With Rituximab SC and Immunochemotherapy | Biotech Hunter | Biotech Hunter