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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/NCT01458548




Registration number
NCT01458548
Ethics application status
Date submitted
18/10/2011
Date registered
25/10/2011
Date last updated
25/10/2011

Titles & IDs
Public title
Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (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 (Including 1st+2nd Amendment)
Secondary ID [1] 0 0
PTLD-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-transplantation 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
Treatment: Drugs - CHOP

Treatment: Drugs: Rituximab
Rituximab 375 mg/m2 IV on days 1, 8, 15 and 22.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
number of patients with complete and partial remission
Timepoint [1] 0 0
1 month (plus or minus 7 days) after the last cycle of chemotherapy
Primary outcome [2] 0 0
response duration
Timepoint [2] 0 0
from date of best response until the date of first documented progression, assessed up to 3 years
Secondary outcome [1] 0 0
number of patients with treatment-related death
Timepoint [1] 0 0
from start of treatment, assessed up to 12 months after the end of treatment
Secondary outcome [2] 0 0
overall survival
Timepoint [2] 0 0
from start of treatment until date of death from any cause, assessed up to 3 years

Eligibility
Key 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 )
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
N/A
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
70
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
France
State/province [1] 0 0
Paris
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Sweden
State/province [3] 0 0
Göteborg

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

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01458548
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ralf U Trappe, MD
Address 0 0
Charite University, 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/NCT01458548