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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
This phase-II trial will investigate the efficacy, safety and the tolerability of a
sequential therapy consisting of 4 courses of single agent rituximab followed by 4 courses of
R-CHOP chemotherapy in patients with CD20+ posttransplant lymphoproliferative disorders
(PTLD). However, responders to rituximab achieving a CR after the first 4 applications of
rituximab will go on with rituximab monotherapy and will not receive chemotherapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00590447
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00590447