This study had an major amendment in 12/2006 introducing risk stratified sequential treatment (RSST). The modified protocol is registered with NCT00590447.
Treatment of Patients With Posttransplant Lymphoproliferative Disorder (PTLD) With a Sequential Treatment Consisting of Anti-CD20 Antibody Rituximab and CHOP+GCSF Chemotherapy (Including 1st+2nd Amendment)
Sponsor study identifier
interventional
70
4 countries
4
Study Start
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2008
Actual (reported)Study Completion
October 2011
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
May 2008
Actual (reported)October 2011
Actual (reported)October 18, 2011
Actual (reported)October 25, 2011
Actual (reported)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
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
Rituximab 375 mg/m2 IV on days 1, 8, 15 and 22.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102
Brisbane, Australia
Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital
Paris, 75651, France
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1
Berlin, 13353, Germany
Sahlgrens hospital, Department of Hematology
Gothenburg, 41345, Sweden
Trappe RU, Dierickx D, Zimmermann H, Morschhauser F, Mollee P, Zaucha JM, Dreyling MH, Duhrsen U, Reinke P, Verhoef G, Subklewe M, Huttmann A, Tousseyn T, Salles G, Kliem V, Hauser IA, Tarella C, Van Den Neste E, Gheysens O, Anagnostopoulos I, Leblond V, Riess H, Choquet S. Response to Rituximab Induction Is a Predictive Marker in B-Cell Post-Transplant Lymphoproliferative Disorder and Allows Successful Stratification Into Rituximab or R-CHOP Consolidation in an International, Prospective, Multicenter Phase II Trial. J Clin Oncol. 2017 Feb 10;35(5):536-543. doi: 10.1200/JCO.2016.69.3564. Epub 2016 Dec 19.
Trappe R, Oertel S, Leblond V, Mollee P, Sender M, Reinke P, Neuhaus R, Lehmkuhl H, Horst HA, Salles G, Morschhauser F, Jaccard A, Lamy T, Leithauser M, Zimmermann H, Anagnostopoulos I, Raphael M, Riess H, Choquet S; German PTLD Study Group; European PTLD Network. Sequential treatment with rituximab followed by CHOP chemotherapy in adult B-cell post-transplant lymphoproliferative disorder (PTLD): the prospective international multicentre phase 2 PTLD-1 trial. Lancet Oncol. 2012 Feb;13(2):196-206. doi: 10.1016/S1470-2045(11)70300-X. Epub 2011 Dec 13.
Ralf U Trappe, MD
Charite University, Berlin, Germany
70 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2011
First Posted
October 25, 2011
Study Start
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2008
Actual (reported)Study Completion
October 2011
Actual (reported)Last Updated
October 25, 2011
Record last verified: 2011-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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