Contact information
Type
Scientific
Primary contact
Dr H.R. Koene
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Haematology
Postbus 22660
Amsterdam
1100 DE
Netherlands
+31 (0)20 566 9111
h.r.koene@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HO64
Study information
Scientific title
Acronym
HOVON 64 ITP
Study hypothesis
The percentage of patients reaching complete response (CR), good response (GR) or moderate response (MR) in each treatment arm is greater than 50%.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Immune thrombocytopaenic purpura (ITP)
Intervention
All patients will be randomised between:
Arm A: conventional dose rituximab 375 mg/m^2, 4 weekly doses
Arm B: conventional dose rituximab 375 mg/m^2, 2 weekly + 2 weekly doses, dependent on response
Arm C: high dose rituximab 750 mg/m^2, 2 weekly doses
Intervention type
Drug
Phase
Not Specified
Drug names
Rituximab
Primary outcome measure
The response (CR/GR/MR/NR) to treatment.
Secondary outcome measures
1. Need for emergency treatment (platelet count less than 10 or haemorrhagic diathesis, haemorrhage/bleeding defined by grade 3 or 4 according to NCI CTCAE v3.0)
2. Time to treatment failure/relapse
Overall trial start date
01/09/2005
Overall trial end date
01/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age minimal 18 years
2. Subjects with relapsed or refractory ITP (fulfilling the diagnostic criteria given in appendix A) and platelet numbers less than 30 x 10^9/l
3. Having completed first line treatment with corticosteroids
4. Written informed consent
5. World Health Organization (WHO) performance status less than or equal to 2
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. The presence of an accessory spleen in splenectomized patients
2. Use of anticoagulants or chemotherapy or known other disorders and/or treatments influencing the platelet number within 3 months of randomisation date (tranexaminic acid [Cyklokapron®] treatment is allowed)
3. Pulsed or high dose corticosteroids, IVIG or splenectomy within 3 weeks prior to randomisation. Maintenance corticosteroid therapy is allowed.
4. Prior therapy with rituximab
5. ITP treatments (other than corticosteroids, IVIG or splenectomy) within 3 months prior to randomisation (e.g. cyclosporin, vincristine). Stable treatment with non-immunosuppressive medication (i.e. danazol, dapson, vitamin C) is permitted.
6. Inadequate renal and liver function, i.e. creatinine or bilirubin greater than 25 x the upper normal value
7. Neutrophil count less than 15 x 10^9/l and haemoglobin level less than 62 mmol/l
8. Active bleeding (defined by grade 3 or 4 according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3.0)
9. Pregnant or lactating
10. Systemic infections: active viral infections, including human immunodeficiency virus (HIV)
11. Seriously immunocompromised patients
12. Systemic autoimmune disorders (e.g. systemic lupus erythematosus [SLE])
13. Current malignant disease
14. Any experimental therapy within 30 days prior to randomisation
Recruitment start date
01/09/2005
Recruitment end date
01/05/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DE
Netherlands
Sponsor information
Organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands) - Data Centre
Sponsor details
Erasmus Medical Centre
Daniel den Hoed Kliniek
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 439 1568
hdc@erasmusmc.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list