Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00590447




Registration number
NCT00590447
Ethics application status
Date submitted
28/12/2007
Date registered
10/01/2008
Date last updated
7/03/2017

Titles & IDs
Public title
Risk Stratified Sequential Treatment for CD20-positive PTLD
Scientific title
Treatment of Patients With Posttransplant Lymphoproliferative Disorder (PTLD) With a Sequential Treatment Consisting of Anti-CD20 Antibody Rituximab and CHOP+GCSF Chemotherapy (PTLD-1/3)
Secondary ID [1] 0 0
EudraCT 2005-000743-29
Secondary ID [2] 0 0
PTLD-1, 3rd. amendment
Universal Trial Number (UTN)
Trial acronym
PTLD-1/3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PTLD 0 0
Posttransplant Lymphoproliferative Disorder 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - rituximab monotherapy
Treatment: Drugs - sequential R-CHOP

Experimental: A - All patients will receive 4 courses of rituximab on days 1, 8, 15 and 22. Patients achieving a CR after the first 4 applications of single agent rituximab (evaluated between day 40 to 50) will go on with 4 further courses of single agent rituximab on days 50, 72, 94 and 116.

Experimental: B - All patients will receive 4 courses of rituximab on days 1, 8, 15 and 22. Patients who do not achieve a CR after the first 4 applications of single agent rituximab (evaluated between day 40 to 50) will go on with 4 courses of R-CHOP on days 50, 72, 94 and 116.


Treatment: Drugs: rituximab monotherapy
375 mg/m2, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between course 4 and 5 the patients directly enter R-CHOP chemotherapy (Arm B).

Treatment: Drugs: sequential R-CHOP
375 mg/m2 rituximab, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. Cyclophosphamid 750 mg/m2, adriamycine 50 mg/m2 and vincristine 1.4mg/m2, IV and prednisone 50mg/m2, PO every 3 weeks at days 50, 72, 94 and 116.

In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between antibody and R-CHOP administration the patients directly enter R-CHOP chemotherapy.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective is the evaluation of the efficacy.For this aim the overall objective response rates after therapy = complete and partial response and the duration of the response will be measured.
Timepoint [1] 0 0
evaluated 4 weeks after comleting therapy
Secondary outcome [1] 0 0
The secondary objective is to determine the adverse events and tolerability of rituximab and/or chemotherapy. Furthermore, the long-term safety will be determined, especially the frequency of complicating infections and the overall survival.
Timepoint [1] 0 0
within 2 years of follow up

Eligibility
Key inclusion criteria
* PTLD with or without EBV association, confirmed after biopsy or resection of tumor
* 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 )
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102 - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Italy
State/province [4] 0 0
Torino
Country [5] 0 0
Poland
State/province [5] 0 0
Gdynia
Country [6] 0 0
Sweden
State/province [6] 0 0
Göteborg

Funding & Sponsors
Primary sponsor type
Other
Name
Charite University, Berlin, Germany
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hanno Riess, MD
Address 0 0
Charité, Campus Virchow-Klinikum Berlin, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Trappe RU, Dierickx D, Zimmermann H, Morschhauser ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00590447