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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00004179




Registration number
NCT00004179
Ethics application status
Date submitted
21/01/2000
Date registered
27/01/2003
Date last updated
27/07/2017

Titles & IDs
Public title
Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Scientific title
Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study
Secondary ID [1] 0 0
EORTC-20981
Secondary ID [2] 0 0
EORTC-20981
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 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
Other interventions - rituximab
Treatment: Drugs - CHOP regimen
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - prednisone
Treatment: Drugs - vincristine sulfate

Other interventions: rituximab


Treatment: Drugs: CHOP regimen


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: doxorubicin hydrochloride


Treatment: Drugs: prednisone


Treatment: Drugs: vincristine sulfate


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response to treatment
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
from randomization
Secondary outcome [2] 0 0
Progression Free survival
Timepoint [2] 0 0
from randomization

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically proven stage III or IV follicular non-Hodgkin's
lymphoma (NHL)

- Relapsed after or no response (no change/progressive disease) to no more than 2
adequate non-anthracycline-containing systemic chemotherapy regimens

- At least 2 months of single-agent therapy (e.g., chlorambucil) AND/OR

- At least 2 consecutive courses of polychemotherapy (e.g., cyclophosphamide,
vincristine, and prednisone) or purine analogues

- Complete or partial remission or no change for at least 4 weeks after completion of
prior therapy OR progression during one of a maximum of 2 prior therapy regimens

- CD20 positive

- At least 1 bidimensionally measurable mass

- No greater than 10,000,000/mL circulating tumor cells

- IgG levels at least 3 g/L

- No low-grade NHL transformed into intermediate- or high-grade NHL

- No symptomatic CNS lymphoma

- No bone marrow involvement only NOTE: A new classification scheme for adult
non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate", or
"high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase less than 2.5 times ULN

Renal:

- Creatinine less than 2.5 times ULN

- BUN less than 2.5 times ULN

Cardiovascular:

- No severe cardiac disease (i.e., severe heart failure requiring symptomatic treatment)

Pulmonary:

- No severe pulmonary disease

Other:

- No severe neurologic or psychiatric disease

- No severe metabolic disease

- Not pregnant

- Fertile patients must use effective contraception

- No prior malignancy within the past 5 years except nonmelanomatous skin cancer,
carcinoma in situ of the cervix, or other cancer curatively treated with surgical
therapy

- HIV negative

- No uncontrolled asthma or allergy requiring steroids

- No known hypersensitivity or prior anaphylactic reaction to murine proteins or any
component of study drug

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior rituximab

- No prior allogeneic or autologous peripheral blood stem cell transplantation

- Concurrent filgrastim (G-CSF) for stem cell mobilization allowed

Chemotherapy:

- See Disease Characteristics

- No prior anthracyclines or mitoxantrone

- No concurrent chemotherapy for stem cell mobilization

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified
Minimum age
18 Years
Maximum age
120 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Cancer Therapy Centre at Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Institute of Oncology at Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [6] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [7] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [8] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [9] 0 0
St. George Hospital and Community Health Service - Sydney
Recruitment hospital [10] 0 0
Westmead Breast Centre at NSW Breast Cancer Institute - Westmead
Recruitment hospital [11] 0 0
Westmead Hospital - Westmead
Recruitment hospital [12] 0 0
Wollongong Hospital - Wollongong
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Wesley Medical Centre - Auchenflower
Recruitment hospital [14] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [15] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [16] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [17] 0 0
Townsville General Hospital - Townsville
Recruitment hospital [18] 0 0
Royal Adelaide Hospital Cancer Centre - Adelaide
Recruitment hospital [19] 0 0
Ashford Cancer Centre - Ashford
Recruitment hospital [20] 0 0
Flinder Medical Centres - Bedford Park
Recruitment hospital [21] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [22] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [23] 0 0
St. John of God Hospital - Ballarat
Recruitment hospital [24] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [25] 0 0
John Fawkner Hospital - Coburg
Recruitment hospital [26] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [27] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [28] 0 0
Frankston Hospital - Frankston
Recruitment hospital [29] 0 0
Geelong Hospital - Geelong
Recruitment hospital [30] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [31] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [32] 0 0
Garden Consulting Rooms - Mornington
Recruitment hospital [33] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [34] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [35] 0 0
Mount Medical Centre - Perth
Recruitment hospital [36] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [37] 0 0
Sir Charles Gairdner Hospital - Perth - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
NSW 2031 - Randwick
Recruitment postcode(s) [6] 0 0
2065 - St. Leonards
Recruitment postcode(s) [7] 0 0
2010 - Sydney
Recruitment postcode(s) [8] 0 0
2050 - Sydney
Recruitment postcode(s) [9] 0 0
2217 - Sydney
Recruitment postcode(s) [10] 0 0
2145 - Westmead
Recruitment postcode(s) [11] 0 0
2500 - Wollongong
Recruitment postcode(s) [12] 0 0
4066 - Auchenflower
Recruitment postcode(s) [13] 0 0
4029 - Brisbane
Recruitment postcode(s) [14] 0 0
4102 - Brisbane
Recruitment postcode(s) [15] 0 0
4120 - Greenslopes
Recruitment postcode(s) [16] 0 0
4810 - Townsville
Recruitment postcode(s) [17] 0 0
5000 - Adelaide
Recruitment postcode(s) [18] 0 0
5035 - Ashford
Recruitment postcode(s) [19] 0 0
5042 - Bedford Park
Recruitment postcode(s) [20] 0 0
5011 - Woodville
Recruitment postcode(s) [21] 0 0
7000 - Hobart
Recruitment postcode(s) [22] 0 0
3350 - Ballarat
Recruitment postcode(s) [23] 0 0
3128 - Box Hill
Recruitment postcode(s) [24] 0 0
3058 - Coburg
Recruitment postcode(s) [25] 0 0
8006 - East Melbourne
Recruitment postcode(s) [26] 0 0
3065 - Fitzroy
Recruitment postcode(s) [27] 0 0
3199 - Frankston
Recruitment postcode(s) [28] 0 0
3200 - Geelong
Recruitment postcode(s) [29] 0 0
3084 - Heidelberg
Recruitment postcode(s) [30] 0 0
3181 - Melbourne
Recruitment postcode(s) [31] 0 0
3931 - Mornington
Recruitment postcode(s) [32] 0 0
3050 - Parkville
Recruitment postcode(s) [33] 0 0
6160 - Fremantle
Recruitment postcode(s) [34] 0 0
6000 - Perth
Recruitment postcode(s) [35] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
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Antwerp
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Ghent
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Belgium
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Leuven
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Roeselare
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Belgium
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Wilrijk
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Canada
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Alberta
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Canada
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British Columbia
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Canada
State/province [10] 0 0
Manitoba
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Canada
State/province [11] 0 0
New Brunswick
Country [12] 0 0
Canada
State/province [12] 0 0
Newfoundland and Labrador
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Canada
State/province [16] 0 0
Saskatchewan
Country [17] 0 0
Denmark
State/province [17] 0 0
Copenhagen
Country [18] 0 0
Denmark
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Vejle
Country [19] 0 0
Egypt
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Cairo
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France
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Bordeaux
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France
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Villejuif
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Hungary
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Budapest
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Italy
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Aviano
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Netherlands
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's-Gravenhage
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's-Hertogenbosch
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Alkmaar
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Almere
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Amersfont
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Amsterdam
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Apeldoorn
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Bergen-op-Zoom
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Capelle aan den Ijssel
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Purmerend
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Roermond
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Roosendaal
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Stadskanaal
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Zeist
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Christchurch
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New Zealand
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Hamilton
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Norway
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Bergen
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Norway
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Oslo
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Norway
State/province [92] 0 0
Trondheim
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Poland
State/province [93] 0 0
Warsaw
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Portugal
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Lisbon
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Slovakia
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Bratislava
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Slovenia
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Ljubljana
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South Africa
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Brooklyn Square
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South Africa
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Johannesburg
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South Africa
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Parktown
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Sweden
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Gothenburg (Goteborg)
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Sweden
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Linkoping
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Sweden
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Lulea
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Sweden
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Lund
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Sweden
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Orebro
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Sweden
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Stockholm
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Sweden
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Sundsvall
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Sweden
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Umea
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England
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United Kingdom
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Northern Ireland
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Wales
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United Kingdom
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Chichester
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Hull
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Kettering, Northants
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Stafford
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United Kingdom
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Swindon,

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lymphoma Trials Office
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Stichting Hemato-Oncologie voor Volwassenen Nederland
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australasian Leukaemia and Lymphoma Group
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
NCIC Clinical Trials Group
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Nordic Lymphoma Group
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells
and either kill them or deliver cancer-killing substances to them without harming normal
cells. It is not yet known whether chemotherapy is more effective with or without rituximab
for relapsed non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab
to see how well they work compared to combination chemotherapy alone in treating patients
with relapsed non-Hodgkin's lymphoma.
Trial website
https://clinicaltrials.gov/show/NCT00004179
Trial related presentations / publications
Deconinck E, Miadi-Fargier H, Pen CL, Brice P. Cost effectiveness of rituximab maintenance therapy in follicular lymphoma: long-term economic evaluation. Pharmacoeconomics. 2010;28(1):35-46. doi: 10.2165/11314070-000000000-00000.
Pompen M, Huijgens PC, et al.: Cost-effectiveness of rituximab for maintenance in patients with follicular non-Hodgkin's lymphoma in the Dutch setting. [Abstract] Blood 112 (11): A-2364, 2008.
Van Oers MH, Hagenbeek A, Van Glabbeke M, Teodorovic I. Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma: a phase III randomized clinical trial--Intergroup Collaborative Study. Ann Hematol. 2002 Oct;81(10):553-7. Epub 2002 Oct 17.
Public notes

Contacts
Principal investigator
Name 0 0
M. H. J. Van Oers, MD
Address 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
Other publications