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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00137995




Registration number
NCT00137995
Ethics application status
Date submitted
25/08/2005
Date registered
30/08/2005

Titles & IDs
Public title
R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma
Scientific title
Randomized Study of ICE Plus RITUXIMAB Versus DHAP Plus Rituximab in Previously Treated Patients With Diffuse Large B-cell Lymphoma, Followed by Randomized Maintenance With Rituximab
Secondary ID [1] 0 0
CORAL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Large-Cell, Diffuse 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rituximab
Treatment: Drugs - Etoposide
Treatment: Drugs - Carboplatine
Treatment: Drugs - Ifosfamide + Mesna
Treatment: Drugs - Cisplatine
Treatment: Drugs - Cytosine Arabinoside
Treatment: Drugs - Dexamethasone
Treatment: Drugs - BCNU
Treatment: Drugs - Etoposide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Melphalan

Experimental: R-ICE - R-ICE + R-BEAM /ASCT Rituximab, Etoposide, Carboplatine, Ifosfamide + Mesna BCNU, Etoposide, Cytarabine, Melphalan Autologous Stem Cell Transplantation

Experimental: R-DHAP - R-DHAP + R-BEAM /ASCT Rituximab, Cisplatine, Cytosine Arabinoside, Dexamethasone BCNU, Etoposide, Cytarabine, Melphalan Autologous Stem Cell Transplantation


Treatment: Drugs: Rituximab
375 mg/m² D-2/D1

Treatment: Drugs: Etoposide
100 mg/m² D1-D2-D3

Treatment: Drugs: Carboplatine
max 800mg D2

Treatment: Drugs: Ifosfamide + Mesna
5 g/m² from D2 to D13

Treatment: Drugs: Cisplatine
100 mg/m² from D1 to D13

Treatment: Drugs: Cytosine Arabinoside
2000 mg/m²/12 h D2 D3

Treatment: Drugs: Dexamethasone
40 mg From D1 to D4

Treatment: Drugs: BCNU
300mg/m² on D-6

Treatment: Drugs: Etoposide
200 mg/m² from D-6 to D-3

Treatment: Drugs: Cytarabine
100 mg/m² from D-6 to D-3

Treatment: Drugs: Melphalan
140 mg/m² on D-2
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MARR (mobilization adjusted response rate)
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
EFS (event free survival)
Timepoint [2] 0 0
2 years post transplantation
Secondary outcome [1] 0 0
Progression rate
Timepoint [1] 0 0
2 years post transplantation
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
2 years post transplantation
Secondary outcome [3] 0 0
Duration of response
Timepoint [3] 0 0
2 years post transplantation

Eligibility
Key inclusion criteria
* Patients with CD20-positive diffuse large B-cell lymphoma. Disease must be histologically proven in case of relapse or partial response.
* Aged 18 to 65 years
* First relapse after complete remission (CR), less than partial remission (PR) or partial response to first line treatment not achieving documented or confirmed complete remission.
* Eligible for transplant
* Previously treated with chemotherapy regimen containing anthracyclines with or without rituximab.
* ECOG performance status 0 to 2.
* Minimum life expectancy of 3 months.
* Signed written informed consent prior to randomization.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Burkitt, mantle-cell and T-cell lymphoma.
* CD20-negative diffuse large cell lymphoma
* Documented infection with HIV and hepatitis B virus [HBV] (in the absence of vaccination)
* Central nervous system or meningeal involvement by lymphoma.
* Not previously treated with anthracycline-containing regimens
* Prior transplantation
* Contra-indication to any drug contained in the chemotherapy regimens.
* Any serious active disease or co-morbid condition (according to the investigator's decision and information provided in the Investigational Drug Brochure [IDB]).
* Poor renal function (creatinine level > 150µmol/l or 1.5-2.0 x upper limit of normal [ULN]); poor hepatic function (total bilirubin level > 30mmol/l [> 1.5 x ULN], transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma; poor bone marrow reserve as defined by neutrophils < 1.5G/l or platelets < 100G/l, unless related to bone marrow infiltration.
* Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
* Pregnant women
* Adult patients unable to provide informed consent because of intellectual impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 3
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
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
481
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Australian leukemia and lymphoma group - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Belgium
State/province [2] 0 0
Yvoir
Country [3] 0 0
Czechia
State/province [3] 0 0
Praha
Country [4] 0 0
Finland
State/province [4] 0 0
Turku
Country [5] 0 0
Germany
State/province [5] 0 0
Hamburg
Country [6] 0 0
Israel
State/province [6] 0 0
Tel-Hashomer
Country [7] 0 0
Sweden
State/province [7] 0 0
Uppsala
Country [8] 0 0
Switzerland
State/province [8] 0 0
Lausanne
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Lymphoma Study Association
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Christian Gisselbrecht
Address 0 0
Lymphoma Study Association
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00137995