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

This study has been terminated.
(This study had an major amendment in 12/2006 introducing risk stratified sequential treatment (RSST). The modified protocol is registered with NCT00590447.)
Information provided by (Responsible Party):
Ralf Trappe, Charite University, Berlin, Germany Identifier:
First received: October 18, 2011
Last updated: October 24, 2011
Last verified: October 2011

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).

Condition Intervention Phase
Post-transplantation Lymphoproliferative Disorder
Drug: Rituximab
Drug: CHOP
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • number of patients with complete and partial remission [ Time Frame: 1 month (plus or minus 7 days) after the last cycle of chemotherapy ] [ Designated as safety issue: No ]
  • response duration [ Time Frame: from date of best response until the date of first documented progression, assessed up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of patients with treatment-related death [ Time Frame: from start of treatment, assessed up to 12 months after the end of treatment ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: from start of treatment until date of death from any cause, assessed up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: December 2002
Study Completion Date: October 2011
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    Rituximab 375 mg/m2 IV on days 1, 8, 15 and 22.
    Drug: CHOP
    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.

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Please refer to this study by its identifier: NCT01458548

Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102
Brisbane, Australia
Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital
Paris, France, 75651
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1
Berlin, Germany, 13353
Sahlgrens hospital, Department of Hematology
Göteborg, Sweden, 41345
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Ralf U Trappe, MD Charite University, Berlin, Germany
  More Information

Additional Information:
No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ralf Trappe, Head German PTLD Study Group, Charite University, Berlin, Germany Identifier: NCT01458548     History of Changes
Other Study ID Numbers: PTLD-1
Study First Received: October 18, 2011
Last Updated: October 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
1st-line therapy
single agent rituximab

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents processed this record on April 16, 2014