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

October 24, 2011 updated by: Ralf Trappe, Charite University, Berlin, Germany

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
        • Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102
  • France
      • Paris, France, 75651
        • Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1
  • Sweden
      • Göteborg, Sweden, 41345
        • Sahlgrens hospital, Department of Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
number of patients with treatment-related death
Time Frame: from start of treatment, assessed up to 12 months after the end of treatment
from start of treatment, assessed up to 12 months after the end of treatment
overall survival
Time Frame: from start of treatment until date of death from any cause, assessed up to 3 years
from start of treatment until date of death from any cause, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Ralf U Trappe, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (ESTIMATE)

October 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTLD-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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