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Clinical picture: Benign

Trial: HOVON 64 ITP

1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms

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HO64 news

Closure of the HOVON 64 ITP study

At this moment 156 patients have been included in the HOVON 64 ITP study.

As agreed, the study will be closed as soon as the 156th patient is included.

This means that you wil not be able to include any more ITP patients into the HOVON 64 ITP study, from this moment. We thank you for participating in this trial.


1. Overview


Anti-CD20 treatment of relapsed or refractory Immune Thrombocytopenic Purpura (ITP) after first line corticosteroid treatment



Study details

Type of study

Prospective randomized Phase II study

Target number of patients


Date of activation


Approved by

METC AMC, June 9, 2005;
amendment 1: May 16, 2006;
amendment 2: January 29, 2008

Change history / amendement

Amendment 2 is active

Study objectives

The main objective of the current study is to investigate the effectiveness of three different dosing schedules rituximab in refractory or relapsed ITP patients, whether or not already splenectomized.
Furthermore, stratification for splenectomy will be performed to reliably assess whether treatment of non-splenectomized patients with rituximab results in avoidance of splenectomy after 1 year follow up.

2. Patient eligibility criteria

Inclusion criteria

Age minimal 18 years
Subjects with relapsed or refractory ITP (fulfilling the diagnostic criteria given in appendix A) and platelet numbers <30 x 10^9/l
Having completed first line treatment with corticosteroids
Written informed consent
WHO performance status <= 2

Exclusion criteria

The presence of an accessory spleen in splenectomized patients.
Use of anticoagulants or chemotherapy or known other disorders and/or treatments influencing the platelet number within 3 months of randomization date (tranexaminic acid (Cyklokapron) treatment is allowed).
Pulsed or high dose corticosteroids, IVIG or splenectomy within 3 weeks prior to randomization. Maintenance corticosteroid therapy is allowed.
Prior therapy with rituximab.
ITP treatments (other than corticosteroids, IVIG or splenectomy) within 3 months prior to randomization (e.g. cyclosporine, vincristine). Stable treatment with non-immunosuppressive medication (i.e. danazol, dapson, vitamin C) is permitted.
Inadequate renal and liver function, i.e. creatinin or bilirubin >2.5 x the upper normal value
Neutrophil count <1.5 x 10^9/l and hemoglobin level <6.2 mmol/l.
Active bleeding (defined by grade 3 or 4 according to NCI CTCAE v3.0)
Pregnant or lactating
Systemic infections: active viral infections, including HIV
Seriously immunocompromised patients
Systemic autoimmune disorders (e.g. Systemic lupus erythematosus (SLE))
Current malignant disease
Any experimental therapy within 30 days prior to randomization.

3. Registration (& randomization) of patients


Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...:

Registration criteria

The following information will be requested:

Protocol number
Institution name
Name of caller/responsible investigator
Patients initials or code
Date of birth
Patients hospital record number
WHO performance status
Date of ITP diagnosis
Eligibility criteria
Splenectomy status

4. Participating parties

Principal investigator

J.J. Zwaginga (

Coordinating investigator(s)

H.R. Koene
G. Vreugdenhil
P.C. Huijgens
B. Biemond


B. van der Holt (

Trial manager

M. Luten (

Central data management

R. Hollestein (

Other functions

Central Laboratory Analysis (Sanquin Research)
M. de Haas (
L. Porcelijn (

Please contact monitors at

5. Participating sites

Included patients *
NL-Alkmaar-Noordwest Ziekenhuisgroep
NL-Amersfoort-Meander MC
NL-Amstelveen-Ziekenhuis Amstelland
NL-Amsterdam-Sint Lucas Andreas ZH, Lucas
NL-Amsterdam-Slotervaart Ziekenhuis
NL-Beverwijk-Rode Kruis Ziekenhuis
Show 25 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos

7. Download documentation / forms


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