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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01458548
Recruitment Status : Terminated (This study had an major amendment in 12/2006 introducing risk stratified sequential treatment (RSST). The modified protocol is registered with NCT00590447.)
First Posted : October 25, 2011
Last Update Posted : October 25, 2011
Information provided by (Responsible Party):
Ralf Trappe, Charite University, Berlin, Germany

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).

Condition or disease Intervention/treatment Phase
Post-transplantation Lymphoproliferative Disorder Drug: Rituximab Drug: CHOP Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : December 2002
Actual Primary Completion Date : May 2008
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. number of patients with complete and partial remission [ Time Frame: 1 month (plus or minus 7 days) after the last cycle of chemotherapy ]
  2. response duration [ Time Frame: from date of best response until the date of first documented progression, assessed up to 3 years ]

Secondary Outcome Measures :
  1. number of patients with treatment-related death [ Time Frame: from start of treatment, assessed up to 12 months after the end of treatment ]
  2. overall survival [ Time Frame: from start of treatment until date of death from any cause, assessed up to 3 years ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
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
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Pathologic Processes
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents