Condition category
Haematological Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

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 measures

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

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

http://www.hovon.nl

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes