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.)
Sponsor:
Information provided by (Responsible Party):
Ralf Trappe, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01458548
First received: October 18, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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.
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458548

Locations
Australia
Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102
Brisbane, Australia
France
Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital
Paris, France, 75651
Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1
Berlin, Germany, 13353
Sweden
Sahlgrens hospital, Department of Hematology
Göteborg, Sweden, 41345
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ralf Trappe, Head German PTLD Study Group, Charite University, Berlin, Germany
ClinicalTrials.gov 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
CHOP
PTLD

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014